Are Patients Whose Study Partners Are Spouses More Likely to be Eligible for Alzheimer's Disease Clinical Trials?
ABSTRACT Alzheimer's disease (AD) clinical trials enroll two participants: a patient and a study partner. The primary caregiver most often fills the role of study partner and most trial study partners are spousal caregivers.
AD trial inclusion criteria were applied to baseline data from 5,674 probable AD dementia research participants in the National Alzheimer's Coordinating Center Uniform Data Set. Eligibility was compared among patients with spousal, adult child, and other types of study partners.
Patients with spousal study partners were more frequently eligible than patients with adult child study partners. Compared to patients with spousal study partners, patients with adult child study partners were more frequently ineligible because of age, residence in skilled nursing facility, low scores on the Mini-Mental State Examination, highscores on the Hachinski Ischemia Scale, and failure to fulfill a minimum number of weekly visits with the study partner.
In this sample, patients with adult child study partners were less likely to qualify for AD clinical trials than were patients with spousal study partners. This may contribute to the lower representation of patients with adult child caregivers in these studies.
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ABSTRACT: ABSTRACT Background: Study partners for dementia research participants are vital to the research process, but little is known about their role, responsibilities, and experiences. Study partners are usually family members or friends - often the patient's informal caregiver - who are knowledgeable about and usually accompany the participant to study visits. This study examines researchers' perspectives on the role of study partners in dementia research. Methods: Qualitative data collection and analytic methods were used. Semi-structured individual interviews with principal investigators, study coordinators, and research nurses (i.e. researchers; n = 17) at two academic research sites were recorded, transcribed, and content analyzed to identify themes in the data. Results: According to researchers, study partners either make or help make research enrollment and post-enrollment decisions, serve as knowledgeable informants for the participants, manage the logistics that enable participants to comply with a study's protocol, and provide comfort and encouragement for the patient to engage in and complete a study. Researchers describe ideal qualities of study partners as being able to provide reliable information, being dependable and adherent to the protocol, and not expecting a benefit. They also report that study partners may face both practical and emotional challenges during research participation. However, researchers believe that study partners derive dementia-related education, caregiver support, and satisfaction from their involvement in research. Conclusions: Investigators, potential study partners, and institutional review boards should be aware of study partners' research responsibilities, challenges, and their interests as caregivers.International Psychogeriatrics 07/2014; 26(10):1-9. DOI:10.1017/S1041610214001203 · 1.89 Impact Factor
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ABSTRACT: Alzheimer disease (AD) research faces challenges to successful enrollment, especially to clinical trials and biomarker studies. Failure to recruit the planned number of participants in a timely manner threatens the internal validity and success of clinical research, raising concerns about external validity and generalizability of results, and possibly leading to disparities in disease treatment. Methods to improve recruitment exist, but require varying levels of staff effort and financial resources, and evidence of effectiveness is often lacking or inconsistent. In this review, we summarize some of the available methods to improve AD research recruitment, the available literature to support or refute these strategies, and some of the experiences at the authors' AD Research Centers. We discuss the use of community-based participatory research principles and participant registries as a means to enhance research enrollment and increase diversity of research samples.Alzheimer disease and associated disorders 12/2013; 28(1). DOI:10.1097/WAD.0000000000000016 · 2.69 Impact Factor
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ABSTRACT: Objective We investigated the proportion of people with dementia who are eligible for and willing to participate in intervention studies.Methods We systematically reviewed 12 studies fitting predetermined criteria, reporting eligibility or participation rates for dementia intervention trials or intervention studies that sought to increase recruitment. We assessed the study validity using a checklist, reported trial eligibility and participation rates and meta-analysed these where appropriate.ResultsIn higher quality studies, 26% [95% confidence interval 19–35%] of people with Alzheimer's disease (AD) attending memory clinics or receiving antidementia medication were eligible for industry drug trials, and 43% of eligible people agreed to participate in one study, suggesting 11% of these populations would take part in drug trials if approached. There was replicated, higher quality evidence that younger people, men and those with more education were more likely to be eligible for AD drug trials. No randomised controlled trials have investigated how to increase recruitment to dementia intervention studies.Conclusion One in 10 people with AD or taking donepezil would, according to best available evidence, take part in industry drug trials if approached. We found no data regarding non-pharmacological intervention or pragmatic drug trial recruitment, but eligibility and participation rates for these studies are probably higher. If international studies are extrapolated to the UK, they suggest the national target of recruiting 10% of people with dementia diagnoses to research may be achieved through a nationwide policy of asking all people with dementia and their carers for consent to be approached for research participation. Copyright © 2013 John Wiley & Sons, Ltd.International Journal of Geriatric Psychiatry 05/2014; 29(5). DOI:10.1002/gps.4034 · 3.09 Impact Factor