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Article

Recruitment Feasibility for a Randomized Controlled Pilot Study of Animal-Assisted Intervention for Hospitalized Older Adults

by
Lisa Townsend
1,2,3,4,*,
Nancy R. Gee
2,3,
Erika Friedmann
5,
Megan K. Mueller
6 and
Sandra B. Barker
2,3
1
Division of Adolescent Medicine, Virginia Commonwealth University School of Medicine, Richmond, VA 23298, USA
2
Department of Psychiatry, Virginia Commonwealth University School of Medicine, Richmond, VA 23298, USA
3
Center for Human-Animal Interaction, Virginia Commonwealth University School of Medicine, Richmond, VA 23298, USA
4
Children’s Hospital of Richmond, Richmond, VA 23298, USA
5
School of Nursing, University of Maryland, Baltimore, MD 21201, USA
6
Tufts Institute for Human-Animal Interaction, Cummings School of Veterinary Medicine, Tufts University, Medford, MA 02155, USA
*
Author to whom correspondence should be addressed.
J. Ageing Longev. 2024, 4(4), 404-416; https://doi.org/10.3390/jal4040029
Submission received: 14 October 2024 / Revised: 27 November 2024 / Accepted: 28 November 2024 / Published: 3 December 2024
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Abstract

:
This study evaluated the feasibility of recruiting hospitalized older adults into a randomized controlled trial (RCT) comparing an animal-assisted intervention (AAI) involving visits from therapy dogs with an active control (conversation with a volunteer) and treatment as usual (TU) for addressing health and mental health outcomes. Recruitment occurred on acute care hospital units and a long-term physical rehabilitation facility. Feasibility data included the number of recruitment contacts, recruitment rate, and reasons for non-enrollment. The recruitment pool included 1124 patients; the recruitment rate was 4.8% (n = 54). This study explored the difficulties inherent in recruiting medically ill, hospitalized older adults for an RCT of hospital-based therapy dog visits. We believe this is the first RCT of its kind to evaluate the feasibility of recruiting this population for an animal-assisted intervention. Although the intervention was well received, older adults’ illnesses presented significant barriers to study enrollment. Strategies for improving the recruitment of hospitalized older adults for RCTs are discussed.

1. Introduction

The challenge of recruiting older adults for participation in randomized controlled trials (RCTs) is not new [1]. Factors such as ill health, fatigue, and trial demand characteristics influence potential participants’ decisions about whether to enroll. Hospitalized older adults represent a unique subpopulation in that they are particularly at risk of social isolation, loneliness, and associated sequelae and are less likely to enroll in intervention and health outcome research. McDonald et al. [2] found that among 122 publicly funded RCTs in the UK, half of which were conducted in hospitals, only 31% reached their target planned recruitment goals.
Rigorous studies of health interventions and outcomes are critical to improving the lives of older adults struggling with acute and chronic illnesses that require inpatient hospital stays. Older adults are at particular risk of loneliness given their increased potential for social isolation due to medical illnesses and the physical limitations associated with aging. The sequelae of hospitalization include decreased mobility, independence, and engagement in self-care activities [3]; furthermore, hospitalization is associated with increased rates of depression among older adults [4]. These factors further increase the likelihood of subsequent inpatient stays [5]. Hospitalization and the associated disruption in social connections and activities place older adults at increased risk for chronic loneliness, which exacts a toll on physical and psychological health—so much so that it has been designated a worldwide public health concern [6]. Loneliness is linked with an array of negative health outcomes such as depression, anxiety, sleep disruption, functional disability, and impaired cognition [7] as well as increased risk of mortality [8].
The healthcare sector is uniquely positioned to mobilize evidence-based interventions to address loneliness and potentially mitigate its consequences [9]. The feasibility of a variety of short-term, inpatient interventions for older adult inpatients has been evaluated, including video game-based exercise [10,11], music therapy [12], physical rehabilitation [13], bedside photographs [14], and goal-planning conversations [15]. Despite the wide array of interventions studied, little research has evaluated animal-assisted interventions using randomized controlled trial methodology among hospitalized older adults. For this study, we used the International Association of Human–Animal Interaction Organizations (IAHAIO) [16] definition of animal-assisted interventions (AAIs): “a goal oriented and structured intervention that intentionally includes or incorporates animals in health, education and human services (e.g., social work) for the purpose of therapeutic gains in humans”. This definition subsumes terms such as “animal-assisted activities” and “therapy animal visits” and is differentiated from “animal-assisted therapies”, which involve licensed providers and the formal documentation of therapeutic progress.
The role of therapy animals in treating depression and anxiety among older adults in long-term residential care has been well studied. However, methodological differences in intervention design, dosage, and implementation hamper our ability to draw precise conclusions regarding efficacy. Many studies suggest potential efficacy but do not address causal or mechanistic questions [17,18]. Such studies demonstrate that therapy animal visits are popular among patients [18] and staff [19,20] and suggest causal relationships between therapy animal visits and reduction in depressive symptoms [17], pain [21], and lack of motivation [22] among many types of patients. However, given the recruitment challenges associated with RCTs involving older adults, understanding strategies for participant enrollment, engagement, and retention in animal-assisted interventions is key to establishing feasibility.
Given the absence of randomized controlled studies of animal-assisted interventions for hospitalized older adults, we employed an RCT design to evaluate the efficacy of therapy animal visits for addressing depression, loneliness, and anxiety in this vulnerable patient population with the aim of establishing the feasibility of recruitment and intervention methods. Our study also addresses a significant limitation in the existing literature by utilizing a consistent, well-defined animal-assisted visit protocol. In this paper, we focus on recruitment methodology and findings relevant to the feasibility of recruiting and enrolling hospitalized older adults in the study. Findings are presented in accordance with the CONSORT guidelines for pilot and feasibility trials (see Figure 1) [23].
The study was approved by the University Institutional Review Board (protocol #HM20021567) and was deemed exempt from review by the University’s Institutional Animal Care and Use Committee. It was also reviewed and approved by the Mars Research Review Board and the Waltham Animal Welfare and Ethical Review Board. The study protocol was defined as a pilot feasibility trial with enrollment/non-enrollment outcomes specified as outcome variables for the study. During recruitment, the study staff recognized and honored passive non-consent or reluctance to participate. This is often indicated through non-verbal signals/body language or deferring consent. The study staff noted all the examples of observed passive non-consent or unenthusiastic “consent” and documented this per protocol. We did not pursue participants if they did not present a clear indication that they wished to hear about and potentially participate in the study. Our presentation of these recruitment data follows the CONSORT reporting guidelines for feasibility RCTs.

2. Materials and Methods

The aims of the larger primary study were to (1) evaluate the feasibility of a therapy dog visitation intervention over three consecutive days compared to a conversational control intervention (CC) and a treatment-as-usual control condition (TAU); (2) assess the efficacy of therapy dog visitation compared to CC and TAU for improving depression, anxiety, mood, loneliness, and health-related quality-of-life outcomes; (3) obtain information required to estimate sample size for a large randomized controlled trial (RCT) evaluating the outcomes of the therapy dog visitation program among a larger sample of inpatients. This paper focuses on Aim 1.

2.1. Intervention

The dogs involved in this study are privately owned, registered therapy dogs who are a part of the Center for Human–Animal Interaction “Dogs on Call” (DOC) program [24]. DOC is an evidence-based program that provides therapy dog visits to patients, staff, and students at an academic hospital and medical center. All the dog-handler teams must hold current registration with Pet Partners or Alliance of Therapy Dogs with an accompanying American Kennel Club Canine Good Citizen title and complete a series of on-site evaluations by DOC personnel to ensure that the dogs are comfortable in the hospital setting. The handlers are registered hospital volunteers who undergo a background check and trainings on patient interactions and privacy during the onboarding process.
(1)
Animal-assisted intervention (AAI): Participants took part in a 20 min, non-scripted interaction with a Dogs on Call therapy dog and handler team on three consecutive days. The handlers were provided with specific discussion topics, such as sports, the weather, dogs, or other animals to facilitate fidelity and treatment consistency.
(2)
Conversational control (CC): Participants interacted with a therapy dog handler who visited them without a dog and participated in a 20 min, informal social interaction with similar discussion topics as described above. The sessions were repeated on three consecutive days.
(3)
Treatment as Usual (TAU): Participants received treatment as usual without any additional intervention. They were asked to engage in their usual activities, such as watching television, reading, or resting, during the 20 min “intervention” period.
(4)
Participants were asked to complete a set of 1-month and 6-month follow-up questionnaires following their discharge from the hospital.

2.2. Setting

Hospitalized older adults were recruited from two inpatient facilities: an academic teaching hospital (Site 1) and a long-term physical rehabilitation facility (Site 2). Table 1 highlights specific medical floors on which recruitment took place at Site 1. At Site 2, participants were recruited from every floor except for the traumatic brain injury unit.

2.3. Recruitment Procedures: Participant Identification and Consent

At both sites, clinical staff were informed about the study and given fliers summarizing the study activities. The study team visited units at Site 1 once or twice weekly to obtain a list of patients that they were approved to approach. Providers at Site 2 generated a weekly list of patients and the study team approached them at the beginning of each week. In both cases, the study staff approached patients in their rooms to explain the study after seeking permission from the clinical staff to enter clinical units. The interested patients were given an information packet that outlined the study procedures and contained informed consent for study screening and enrollment. Potential participants were approached a maximum of three times unless they provided a clear indication that they wished to continue discussing the study. This method allowed the study team to honor passive non-consent while maximizing the ability to recruit the interested patients whose treatment regimen required multiple contacts before recruitment was able to be completed.

2.4. Inclusion/Exclusion Criteria

The study inclusion criteria consisted of the following: (1) age 60 years or older; (2) projected hospital admission lasting for five days; (3) English-speaking; (4) ability to understand study procedures and provide written informed consent; and (5) Brief Interview for Mental Status (BIMS) score of 13 or greater. The exclusion criteria included (1) fear of or allergy to, dogs; (2) documented contact precautions requiring study staff to don extra personal protective equipment; or (3) a positive SARS-CoV-2 test.

2.5. Recruitment Uptake

Study referrals and recruitment outcomes were tracked, including study site, patient name, unit, contact date, and outcome. Figure 1 illustrates the recruitment outcomes for all the patients approached. Outcome codes were recorded as follows: (1) enrolled; (2) declined; (3) considering participation; (4) screen failures; (5) patient unavailable; (6) not appropriate for the study; (7) missed opportunity; and (8) duplicate referral. “Considering participation” indicated the patients who remained undecided whether they wished to join the study. “Screen failures” represented the patients who expressed interest in study participation but did not meet inclusion criteria. The “patient unavailable” code was applied for the patients who resided in the unit but were unable to be contacted because they were sleeping or attending medical procedures. The “not appropriate for the study code” included patients on contact precautions as well as the patients who were transferred elsewhere, discharged before contact could be made, or were scheduled to be discharged before the study procedures could be completed. The “missed opportunity” code included the patients who had expressed interest in the study but were not re-contacted due to time constraints or the enrollment of other participants. “Duplicate referrals” included the patients who had been referred to the study previously and declined participation. If patients spontaneously provided a reason why they declined to participate, the reason was recorded.

2.6. Criteria for Progressing from Pilot Study to Larger Randomized Controlled Trial

A priori criteria for considering the pilot to be successful were (1) the ability to recruit 60 participants [25]; (2) retaining participants in the study through the first intervention visit; and (3) statistically significant effects favoring the animal-assisted intervention condition compared to the conversational control and treatment-as-usual conditions. We present the results for the first criterion in this paper. The findings for the second and third are presented elsewhere. A chi-squared test using the equiprobability model was employed to evaluate the differences between our enrollment rate and those of similar randomized feasibility studies. These comparison studies were identified through a literature search based on population (older adults), setting (inpatient), delivery of an intervention, and the reported ratio of enrolled vs. eligible participants. Pearson’s standardized residuals were used to determine whether differences between study enrollment rates were statistically significant using a cutoff value of ±2.0 [26].

3. Results

Recruitment began in November 2021 and ended in May 2023, a period of 18 months. During that time, a potential 1124 participants were referred to the study (see Figure 1). The overall recruitment rate was 4.8% (n = 54). A total of 37.8% (n = 425) declined participation, with 4.6% (n = 52) considering but not enrolling, 0.8% (n = 9) screen failures, 26.6% (n = 299) unavailable, 24.2% (n = 272) not study appropriate, 0.6% (n = 7) missed opportunities, and 0.5% (n = 6) duplicate referrals. The average number of contacts made to potential participants was 2.8 (SD = 2.9). The median number of contacts was 2.0. Most participants (n = 44) were recruited from the long-term physical rehabilitation facility, with fewer enrollments (n = 10) in the acute care hospital. Recruitment efforts were terminated due to declining enrollment numbers and the need to deploy staff to other projects.
The final number of enrolled participants reached 54 of the intended 60. The enrollees’ average age was 70.51 years (SD = 8.01), range = 59–91 years. (Due to an administrative error, one 59-year-old participant was enrolled in the study.) Most of the sample (80%) reported having at least some college education. Seventy-two percent were retired. Table 2 provides demographic characteristics for the enrollees. Demographic data were not gathered for the people who declined participation.
Table 3 presents the enrollment rates for other intervention feasibility studies in hospitalized older adult populations for comparison with our enrollment. Comparison studies were chosen from a literature review with the following criteria: (1) pilot/feasibility studies using (2) randomized controlled trial methods to (3) evaluate an intervention in (4) hospitalized older adults. The average rate of enrollment for those studies was 20.4%. A video game-based exercise intervention had the highest enrollment rate, with 62% success [27]. Lengthier interventions requiring multiple sessions and employing regular exercise or activities generated lower rates of participant uptake [28,29]. Table 2 shows that the recruitment rate (4.8%) for the current study was among the lowest rates in this set of hospital-based intervention feasibility RCTs conducted with older adults. The chi-squared results indicated that the enrollment rate distribution across the comparison studies differed significantly [ χ 2 (7, N = 8) 138.73, p = 0.000], with the current study having a lower recruitment rate than the others. Figure 2 presents the standardized distribution of the studies; Brown [28], the current study, and Ingadottir [30] demonstrated lower enrollment rates than would be expected. In comparison, Altorfer [27] had higher enrollment rates.

4. Discussion

Randomized controlled trials for seriously ill, hospitalized older adults represent one of the most difficult types of studies to conduct. Our study was among a group of older adult intervention feasibility studies demonstrating significantly lower recruitment rates than expected compared to other studies. An important common characteristic of the lowest recruiting studies is that they offered adjunctive interventions in addition to regular treatment. Brown [28] offered a 13-month exercise program initiated during inpatient hospitalization and continued post-discharge. Ingadottir [30] offered nutritional supplements over a 12-month period, also spanning inpatient to post-discharge time periods. Intervention length and difficulties with sustaining exercise and nutritional changes may explain the lower enrollment rates for those studies. Our study represented a brief, adjunctive intervention during the patients’ hospital stays; however, it was adjunctive and not linked with rehabilitation and recovery activities, such as physical therapy. As such, it may have been viewed as an “extra” task to be completed. Altorfer [27] demonstrated the greatest recruitment success among the comparison studies. That study employed a videogame-based exercise and cognitive intervention linked with physical rehabilitation activities during inpatient care. The game was “challenge”-based, with participants receiving feedback on achievements and progression toward increased difficulty levels—the structure appears very similar to culturally popular video games. It is likely that the structure and presentation of Altorfer’s exergame engaged the same mechanisms that maintain people’s interest in video game play. We next discuss the barriers encountered in our study along with strategies to mitigate them and enhance recruitment success.

4.1. Barriers to Recruitment and Enrollment

4.1.1. Patient Unavailability

One of the most common reasons for enrollment difficulty is related to patient unavailability due to other medical procedures. This was especially common at Site 2, the long-term rehabilitation facility. Patients admitted to this hospital were medically stable yet required extensive physical therapy to recover physical functioning. Common medical illnesses among these patients included stroke, fall-related injuries, and amputations. Patients spent most of their day engaged in physical and occupational therapies as well as activity groups for socialization. The recruitment staff frequently had to check multiple times to find patients in their rooms. Once patients were provided with the study information packets, the recruiters either had to schedule a time to return or continue checking the patient’s room to conduct informed consent if a patient expressed interest in study participation. This is consistent with the findings of other studies in this patient population [13].

4.1.2. Late Referrals

Potential participants who expressed interest in the study were sometimes ineligible because they were nearing their discharge date and would have been unable to complete study procedures. Ninety-five participants were ineligible for this reason.

4.1.3. Lack of Interest

The most common reason participants declined was a simple lack of interest in hearing about the study or participating in research. A total of 317 participants indicated that they were not interested in learning about the study. We note that this category likely subsumes many potential reasons why people declined to hear about the study.

4.1.4. Physically Ill Health, Pain, and Fatigue

Consistent with other research [29], 24 participants declined participation due to pain, fatigue, and other symptoms of their illnesses. For some, the energy required to speak with the study recruiters was too much, and this was evident in the first few moments of conversation. This was especially common at Site 1, which included several intensive care units. Patients on these units were acutely ill and struggling with a new-onset illness, injury, or significant exacerbation of the existing conditions. With that said, other participants enrolled despite evidence of significant pain. It is unclear what factors determined whether a patient’s pain was prohibitive to study enrollment.

4.1.5. Intervention Complexity and Burden

Our study involved seven visits, including baseline measures, three intervention days, post-intervention measures, and two sets of follow-up questionnaires mailed to the participants at 1 and 6 months after the intervention. The recruiters observed that the initial description of the study upon introduction to the patient could seem overwhelming given the large amount of information necessary to convey. Feedback from eight patients during recruitment interactions suggests that some patients felt that the level of commitment was too burdensome, which is consistent with the findings of other researchers [30].

4.1.6. Cognitive Deficits

Nine patients expressed interest in study participation and began the screening process to determine eligibility but were excluded due to cognitive impairment. Five out of nine in this group were ineligible for the study because their scores on the BIMS fell below the requisite 13/15 points. Four additional patients had a documented diagnosis of dementia, which precluded study recruitment.

4.1.7. Contact Precautions

Thirteen potential participants were unable to be approached given contact precaution orders that precluded study participation. In some cases, patients were diagnosed with highly communicable bacterial infections or tested positive for the SARS-CoV-2 virus. In other cases, patients were immunocompromised, making exposure to the study team a potential risk to their health.

4.1.8. Staffing Issues

Budget considerations allowed for hiring part-time rather than full-time research assistants. Given the part-time nature of the work, the research assistants frequently held other jobs, which limited their available time for recruitment and follow-up with potential participants. Additionally, recruitment proved so time-consuming that the research assistants often filled their weekly hour limit with efforts to enroll participants, which left little time for conducting the intervention. Recruitment efforts and study interventions were supplemented by the faculty as needed to compensate for gaps in research assistant availability.

4.2. Intervention Characteristics That Facilitated Recruitment

4.2.1. Integration with Clinical Staff

The Dogs on Call hospital visitation program is a long-standing program in the hospital setting at Site 1. Nearing the completion of its twenty-second year, the program is widely popular and well received, providing meaningful interactions with thousands of patients, visitors, and healthcare workers throughout the hospital. Clinical staff on the units where recruitment was conducted often maintained collections of Dogs on Call trading cards depicting the visiting therapy dogs. When study investigators approached clinical managers regarding the study, they commonly received an enthusiastic welcome accompanied by offers of assistance to support approved recruitment strategies. Although Site 2 did not have a formal therapy dog visitation program, it had a facility dog for a short time and as such they welcomed the study enthusiastically in part because it would bring therapy dogs to their facility. The study team interacted regularly with the clinical staff at Site 2 and offered staff, but not other patients, therapy dog visits when a dog was present for the study. A positive relationship between the study team and clinical staff facilitated recruitment and there were no barriers regarding the acceptability of hospital-based therapy dog visitation to surmount. We recognize that it is possible that this will not be a universal experience for other researchers attempting to evaluate a therapy dog intervention in other hospital facilities that do not currently operate a therapy dog visitation program. Because the Dogs on Call program is so well established as a best practice model it is considered a highly desirable program by regional hospitals.

4.2.2. High Acceptability of Animal-Assisted Intervention

Consistent with the findings of other researchers [32], the idea of therapy dog visitation was generally well received among the patients. Some who declined indicated that although they loved the idea of visits from a therapy dog, they felt too overwhelmed to navigate study participation. Only ten potential participants declined the study because they disliked dogs, while six declined because they were “cat people”. Only one participant withdrew because she was randomized to one of the control conditions.

4.2.3. Flexible Communication and Convenient Intervention Schedule

Given the potential for sensory and mobility challenges in older adult populations [33], the study activities were designed for maximum flexibility in modes of communication with the participants. The study team employed verbal communication to introduce the study along with a printed study packet that conveyed the study activities succinctly in a one-page, large-print format. Study consent forms were reviewed verbally and left with potential participants as long as needed for their review, sometimes over several days. Following the review, the participants could engage with the study staff for clarification as needed. When introducing the study, the research staff indicated that intervention visits could be flexibly scheduled and modified as needed to accommodate medical procedures and visits from friends and family. All the intervention visits were conducted in the patients’ hospital rooms.

4.3. Protocol Modifications for Future Studies

This study met with many previously described challenges to conducting randomized controlled trials with hospitalized older adults. Table 4 presents the main challenges to study enrollment and suggested modifications to support a larger randomized controlled trial. These suggestions are based on our experience during the 18-month recruitment period. Many recommended modifications for older adults were implemented prior to recruitment initiation, including succinct, large-print materials; multiple modalities for communication; and allowing sufficient time for patients to review materials and ask questions [34]. Key modifications included budgeting for at least one full-time research assistant to support recruitment and intervention activities, reducing intervention complexity, streamlining the initial study description, and involving multiple sites to achieve the target number for a fully powered randomized controlled trial. Additional strategies include shifting intervention points to post-hospitalization in the context of medical follow-up and increasing study visibility through posters, flyers, and informational videos displayed in patient rooms and care areas as well as setting recruitment appointments with patients.

4.3.1. Staffing

Recruitment for this study consumed more staff resources than conducting the intervention and data collection. At times, multiple research team members assisted with recruitment. We recommend employing at least one full-time research assistant devoted solely to the project. This will provide for staff availability for recruitment and consistency in contact with patients.

4.3.2. Reducing Intervention Complexity/Streamlining Study Description

Some patients seemed overwhelmed by the initial study description, which included a discussion of the intervention visits along with additional data collection timepoints. The total number of study visits equaled seven over a six-month period, with five taking place during hospitalization and two follow-ups by mail. Participant feedback once enrolled suggested that the study burden was minimal; it appears that the bulk of the study “burden” on the participants was hearing the initial description. The study team focused on providing full verbal information regarding the time commitment for the study when introducing it to the participants. Upon reflection, this introduction could be streamlined to convey the same information more succinctly. Additional strategies include informing potential participants about the study early in their hospital/rehabilitation stay and providing multi-modal study advertisements, such as video-based descriptions displayed on hospital room television screens.

4.3.3. Involving Multiple Sites

The most important modification in our opinion will be involving multiple sites that also have established hospital-based therapy dog visitation programs. Many hospitals and rehabilitation facilities across the country have such programs; involving at least three other sites of comparable size would allow the recruitment of at least 200 participants if our site’s experience is representative. The Reducing End-of-Life Symptoms with Touch REST study provides an exemplar of a multi-site intervention trial for palliative care/hospice patients, including strategies for local recruitment, training, and fidelity monitoring [35].

4.3.4. Altering Intervention Points

Offering the study at or near patients’ discharge and conducting study activities after patients return home is a final suggestion for easing enrollment difficulties. Patients who are discharged have often experienced improvement in their medical conditions and associated fatigue and pain. Given that one of the intended outcomes of animal-assisted interventions is to improve health by intervening in symptoms of loneliness, the efficacy of such interventions could be evaluated equally well in an outpatient post-acute care context.

5. Conclusions: Implications for Progressing from Pilot Study to Larger Randomized Controlled Trial

Our enrollment data are consistent with the findings of many other studies in a medically fragile older adult population. This study adds the unique element of a popular therapy dog visitation program, which we expected to increase the older adults’ desire to participate. Nevertheless, we found recruitment to be difficult despite the high appeal of therapy dog visitation described in the AAI literature. Despite these challenges, research regarding health and mental health outcomes among seriously ill older adults remains an important public health goal. Looking ahead to maximizing chances for success in recruiting for a larger-scale clinical trial, we recommend obtaining buy-in from clinical staff—the staff support we received greatly facilitated recruitment efforts. In addition, creating broad awareness of the study upon hospital admission, hiring full-time staff for recruitment, and engaging multiple sites are the key modifications necessary for conducting this type of intervention study on a larger scale.
Our study contributes uniquely to the AAI literature by highlighting the barriers to randomized controlled trials in older adult populations. AAI science is largely characterized by non-randomized designs, including anecdotal studies, single-group designs, and quasi-experimental research. AAI researchers have called for the implementation of more stringent, methodologically rigorous studies that shed light on causal effects and mechanisms [36,37]. Our work highlights the barriers to conducting AAI RCTs in medically vulnerable populations and offers insights that can increase the likelihood of success.

Author Contributions

Conceptualization, N.R.G., E.F. and S.B.B.; methodology, N.R.G., E.F., M.K.M., S.B.B. and L.T.; formal analysis, E.F.; investigation, N.R.G., L.T. and S.B.B.; data curation, L.T.; writing—original draft preparation, L.T.; writing—review and editing, L.T., N.R.G., E.F., M.K.M. and S.B.B.; supervision, L.T. and N.R.G.; project administration, N.R.G.; funding acquisition, N.R.G. All authors have read and agreed to the published version of the manuscript.

Funding

This research was funded by an unrestricted grant from Mars Petcare UK/Waltham Petcare Science Institute to the Center for Human–Animal Interaction/Medical College of Virginia Foundation which is a 501c(3) organization.

Institutional Review Board Statement

The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Virginia Commonwealth University (protocol code HM20021567 approved 5 October 2021). The protocol was deemed exempt from review by the Virginia Commonwealth University Animal Care and Use Committee.

Informed Consent Statement

Informed consent was obtained from all the subjects involved in the study.

Data Availability Statement

The datasets used in this article are not publicly available because they are part of an ongoing study.

Acknowledgments

The authors wish to thank the study participants for their generosity of time and spirit as well as the Dogs on Call volunteer research teams for making this work possible.

Conflicts of Interest

In the past three years, Dr. Townsend’s spouse has received research support, acted as a consultant, and/or has received honoraria from Abbvie, Acadia, Adamas, Afecta, Ajna, Akili, Alkermes, Allergan, American Academy of Child & Adolescent Psychiatry, American Psychiatric Press, Arbor, Axsome, BioXcel, Idorsia, Intracellular Therapies, Iqvia, Lundbeck, Medavante Prophase, MJH Life Sciences, Neurim, NIH, Novartis, Otsuka, Oxford University Press, PaxMedica, PCORI, Pfizer, Physicians’ Postgraduate Press, Radius, Receptor Life Sciences, Sage, Signant Health, Sunovion, Supernus Pharmaceuticals, Syneos, Takeda, Tris, and Viatris. Dr. Gee receives or has received research support, served as a member of the speaker’s bureau, acts or acted as a consultant for, and/or receives or received honoraria from Animal-Assisted Interventions Singapore; Deakin University, Australia; Mars Petcare, UK; Nestle Purina, France; Open University, Netherlands; Pet Partners; Purdue University; Society for Companion Animal Studies; Singapore National Parks; the Human–Animal Bond Research Institute; the University of Sydney, Australia; Wallis Annenberg Petspace; and the Waltham Petcare Science Institute, UK. Dr. Friedmann has received research support, acted as a consultant, and/or received honoraria from Mars Petcare, Florida Atlantic University, the National Institutes of Health, and the Waltham Petcare Science Institute. Dr. Mueller receives research support from the National Institutes of Health, the Human–Animal Bond Research Institute, Mars Petcare UK, and the Brain and Behavior Research Foundation and is a consultant for the Massachusetts Department of Public Health. Dr. Barker has received research support, acted as a consultant, and/or received honoraria or royalties from Iams Company, Mars Petcare, National Institutes of Health, Pet Partners, the Human–Animal Bond Research Institute, Wallis Annenberg Petspace, Virginia Veterinary Medical Association, National Board for Certified Counselors, Northern Virginia Mental Health Institute, University of Otago (New Zealand), Research Triangle Institute, Belgium Royal Academy of Medicine, University of Kansas-Wichita, and U.S. Psychiatric and Mental Health Congress. The sponsor had no role in the design, execution, interpretation, or writing of the study.

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Jal 04 00029 g001
Figure 1. CONSORT enrollment flowchart.
Figure 1. CONSORT enrollment flowchart.
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Figure 2. Distribution of Pearson’s standardized residuals for selected older adult intervention studies. * Represents studies with significantly higher or lower enrollment rates.
Figure 2. Distribution of Pearson’s standardized residuals for selected older adult intervention studies. * Represents studies with significantly higher or lower enrollment rates.
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Table 1. Study recruitment sites and enrollment rates.
Table 1. Study recruitment sites and enrollment rates.
Site 1—Academic Teaching Hospital
UnitNumber Enrolled
Trauma and transplant 0
Cardiology 2
Orthopedics and neurosurgery 0
Acute care oncology 1
Acute care surgery 1
Surgical intensive care unit (ICU) 2
Cardiac ICU and coronary surgery 1
Neuroscience ICU 2
Orthopedic ICU 1
Total Enrolled = 10
Site 2—Inpatient Rehabilitation Facility
UnitNumber Enrolled
Neurology 14
Multi-specialty 27
Spinal injury 3
Total Enrolled = 44
Table 2. Demographic data for study enrollees.
Table 2. Demographic data for study enrollees.
n (%)
Sex
Female27 (50)
Male27 (50)
Marital Status
Married27 (50)
Widowed13 (24)
Divorced7 (13)
Single/Never married7 (13)
Race
White43 (80)
Black11 (20)
Hispanic/Latine Background
Yes1 (2)
No53 (98)
Table 3. Enrollment rate comparison for hospitalized older adult intervention studies.
Table 3. Enrollment rate comparison for hospitalized older adult intervention studies.
Author (Year) InterventionLengthSettingEnrollment Rate *
Brown (2006) [28]exercise24 weekshospital/home1.5%
Ingadottir (2019) [30] nutritional supplements12 monthshospital/home6.9%
Lindahl (2014) [29]ADL supports1–18.5 hhospital/home12.3%
Kosse (2013) (review) [13]physical rehabilitation3–14 sessions hospitalavg = 15.6%
Lange (2021) [31]melatonin for delirium5 nightshospital18.8%
Lee (2022) [15]goal-setting discussion1 sessionhospital25.9%
Altorfer (2021) [27]exergaming5 daysinpatient rehabilitation61.8%
* enrollment rates were calculated by dividing the number of participants enrolled and randomized by the number of potentially eligible patients admitted to the unit.
Table 4. Barriers to study recruitment and modifications to enhance feasibility.
Table 4. Barriers to study recruitment and modifications to enhance feasibility.
Recruitment ChallengesSuggested Modifications
Part-time staffingOne or more full-time research assistants
Multi-day interventionShortened intervention
Information overloadProvide study information at admission
Informational videos displayed on room televisions
Recruitment visits unexpectedProvide study fliers/advertisements throughout unit
Informational videos displayed on room televisions
Two-site recruitmentEngage multiple sites
Inpatients too illPost-discharge recruitment and follow-up
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MDPI and ACS Style

Townsend, L.; Gee, N.R.; Friedmann, E.; Mueller, M.K.; Barker, S.B. Recruitment Feasibility for a Randomized Controlled Pilot Study of Animal-Assisted Intervention for Hospitalized Older Adults. J. Ageing Longev. 2024, 4, 404-416. https://doi.org/10.3390/jal4040029

AMA Style

Townsend L, Gee NR, Friedmann E, Mueller MK, Barker SB. Recruitment Feasibility for a Randomized Controlled Pilot Study of Animal-Assisted Intervention for Hospitalized Older Adults. Journal of Ageing and Longevity. 2024; 4(4):404-416. https://doi.org/10.3390/jal4040029

Chicago/Turabian Style

Townsend, Lisa, Nancy R. Gee, Erika Friedmann, Megan K. Mueller, and Sandra B. Barker. 2024. "Recruitment Feasibility for a Randomized Controlled Pilot Study of Animal-Assisted Intervention for Hospitalized Older Adults" Journal of Ageing and Longevity 4, no. 4: 404-416. https://doi.org/10.3390/jal4040029

APA Style

Townsend, L., Gee, N. R., Friedmann, E., Mueller, M. K., & Barker, S. B. (2024). Recruitment Feasibility for a Randomized Controlled Pilot Study of Animal-Assisted Intervention for Hospitalized Older Adults. Journal of Ageing and Longevity, 4(4), 404-416. https://doi.org/10.3390/jal4040029

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