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The Effectiveness of Small-group Community-based Information Sessions on Clinical Trial Recruitment for Secondary Prevention of Alzheimer's Disease.

ABSTRACT: Effective and practical recruitment strategies are needed to ensure successful recruitment into the Alzheimer disease clinical trials. To facilitate successful recruitment for the NIH-sponsored A4 (Anti-Amyloid treatment in Asymptomatic Alzheimer's disease, NCT02008357) trial for the secondary prevention of Alzheimer disease, we developed a small-group community information session to attract and recruit potential research participants. After a successful media campaign, 213 participants were screened through telephone for eligibility, identifying 127 potential participants. Participants were given the option of a traditional one-on-one recruitment session or a small-group session. One-on-one recruitment was performed for 15 participants requesting this procedure, and yielded an overall recruitment rate of 67% (n=10). Substantially more individuals (n=112, 88%) requested small-group sessions to learn about the study. After attending the small-group informational sessions, 98% of potential participants self-reported a greater understanding of the study; and the recruitment rate from these sessions was 90%. Small-group sessions not only improved recruitment success rates, but also contributed to significantly shorter median time for consent processes (20 vs. 60 min) and reduced staff time spent on persons not recruited. Small-group education programs are an effective strategy for enhancing recruitment success and facilitating practical recruitment into clinical trials with high recruitment demands.

SUBMITTER: Tarrant SD

PROVIDER: S-EPMC5116426 | biostudies-literature | 2017 Apr-Jun

REPOSITORIES: biostudies-literature

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The Effectiveness of Small-group Community-based Information Sessions on Clinical Trial Recruitment for Secondary Prevention of Alzheimer's Disease.

Tarrant Sarah D SD Bardach Shoshana H SH Bates Kendra K Nichols Heather H Towner Jacqueline J Tamatha Clay C Caban-Holt Allison A Van-Eldik Linda J LJ Murphy Richard R RR Sperling Reisa R Jicha Gregory A GA

Alzheimer disease and associated disorders 20170401 2

Effective and practical recruitment strategies are needed to ensure successful recruitment into the Alzheimer disease clinical trials. To facilitate successful recruitment for the NIH-sponsored A4 (Anti-Amyloid treatment in Asymptomatic Alzheimer's disease, NCT02008357) trial for the secondary prevention of Alzheimer disease, we developed a small-group community information session to attract and recruit potential research participants. After a successful media campaign, 213 participants were sc ...[more]

PMID: 27213625

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Project description:BackgroundIn Alzheimer's disease (AD), pathological changes may arise up to 20 years before the onset of dementia. This pre-dementia window provides a unique opportunity for secondary prevention. However, exposing non-demented subjects to putative therapies requires reliable biomarkers for subject selection, stratification, and monitoring of treatment. Neuroimaging allows the detection of early pathological changes, and longitudinal imaging can assess the effect of interventions on markers of molecular pathology and rates of neurodegeneration. This is of particular importance in pre-dementia AD trials, where clinical outcomes have a limited ability to detect treatment effects within the typical time frame of a clinical trial. We review available evidence for the use of neuroimaging in clinical trials in pre-dementia AD. We appraise currently available imaging markers for subject selection, stratification, outcome measures, and safety in the context of such populations.Main bodyAmyloid positron emission tomography (PET) is a validated in-vivo marker of fibrillar amyloid plaques. It is appropriate for inclusion in trials targeting the amyloid pathway, as well as to monitor treatment target engagement. Amyloid PET, however, has limited ability to stage the disease and does not perform well as a prognostic marker within the time frame of a pre-dementia AD trial. Structural magnetic resonance imaging (MRI), providing markers of neurodegeneration, can improve the identification of subjects at risk of imminent decline and hence play a role in subject inclusion. Atrophy rates (either hippocampal or whole brain), which can be reliably derived from structural MRI, are useful in tracking disease progression and have the potential to serve as outcome measures. MRI can also be used to assess comorbid vascular pathology and define homogeneous groups for inclusion or for subject stratification. Finally, MRI also plays an important role in trial safety monitoring, particularly the identification of amyloid-related imaging abnormalities (ARIA). Tau PET to measure neurofibrillary tangle burden is currently under development. Evidence to support the use of advanced MRI markers such as resting-state functional MRI, arterial spin labelling, and diffusion tensor imaging in pre-dementia AD is preliminary and requires further validation.ConclusionWe propose a strategy for longitudinal imaging to track early signs of AD including quantitative amyloid PET and yearly multiparametric MRI.

Project description:BackgroundScreening to identify individuals with elevated brain amyloid (Aβ+) for clinical trials in Preclinical Alzheimer's Disease (PAD), such as the Anti-Amyloid Treatment in Asymptomatic Alzheimer's disease (A4) trial, is slow and costly. The Trial-Ready Cohort in Preclinical/Prodromal Alzheimer's Disease (TRC-PAD) aims to accelerate and reduce costs of AD trial recruitment by maintaining a web-based registry of potential trial participants, and using predictive algorithms to assess their likelihood of suitability for PAD trials.ObjectivesHere we describe how algorithms used to predict amyloid burden within TRC-PAD project were derived using screening data from the A4 trial.DesignWe apply machine learning techniques to predict amyloid positivity. Demographic variables, APOE genotype, and measures of cognition and function are considered as predictors. Model data were derived from the A4 trial.SettingTRC-PAD data are collected from web-based and in-person assessments and are used to predict the risk of elevated amyloid and assess eligibility for AD trials.ParticipantsPre-randomization, cross-sectional data from the ongoing A4 trial are used to develop statistical models.MeasurementsModels use a range of cognitive tests and subjective memory assessments, along with demographic variables. Amyloid positivity in A4 was confirmed using positron emission tomography (PET).ResultsThe A4 trial screened N=4,486 participants, of which N=1323 (29%) were classified as Aβ+ (SUVR ≥ 1.15). The Area under the Receiver Operating Characteristic curves for these models ranged from 0.60 (95% CI 0.56 to 0.64) for a web-based battery without APOE to 0.74 (95% CI 0.70 to 0.78) for an in-person battery. The number needed to screen to identify an Aβ+ individual is reduced from 3.39 in A4 to 2.62 in the remote setting without APOE, and 1.61 in the remote setting with APOE.ConclusionsPredictive algorithms in a web-based registry can improve the efficiency of screening in future secondary prevention trials. APOE status contributes most to predictive accuracy with cross-sectional data. Blood-based assays of amyloid will likely improve the prediction of amyloid PET positivity.

Project description:IntroductionCancer care has expanded from a disease-focused, survival-oriented model to an approach that now considers how survivors can live well in the aftermath of intensive therapy, where they may deal with significant changes to their bodies, mental health or emotional well-being. Research evidence supports the benefit of exercise during and following cancer treatments for cancer-related symptoms, physical functioning and fitness, and health-related quality of life. To move this efficacy evidence into practice, we designed and launched a 5-year study to evaluate the relative benefit from implementing a clinic-to-community-based cancer and exercise model of care.Methods and analysisA hybrid effectiveness and implementation trial design is being used to evaluate the effectiveness of delivery of community-based exercise and to collect data on implementation of the programme. The study opened in January 2017, with estimated completion by January 2022. The programme will be delivered in seven cities across the province of Alberta, Canada, with sites including three academic institutions, six YMCA locations, Wellspring Edmonton and Calgary, and six municipal fitness centres. Participants are adult cancer survivors (n=2500) from all tumour groups and stages and at any time point along their cancer treatment trajectory, up to 3 years post treatment completion. Survivors take part in a minimum of 60 min of mild-to-moderate intensity full body exercise twice weekly for a 12-week period. The primary effectiveness outcome is the proportion of participants meeting or exceeding 150 min of moderate intensity exercise per week at 1-year follow-up. The Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework will be utilised to capture individual-level and organizational-level impact of the exercise programme at 12 and 24 weeks and 1-year follow-up. The cohort of survivors participating in the study will allow for long-term (>5-year) evaluation of rates of cancer recurrence and secondary cancers beyond the funding period.Ethics and disseminationThe study was approved by the Health Research Ethics Board of Alberta. The study is funded by Alberta Innovates and the Alberta Cancer Foundation. The study will help to answer critical questions on the effectiveness of cancer-specific community-based exercise programming in both the short-term and the long-term. Collectively, the findings will help to inform the acceptability, adoption, feasibility, reach and sustainability of community-based exercise.Trial registration numberNCT02984163; Pre-results.

Project description:ObjectiveTo compare the benefits and harms of a Dutch 10-session Community Occupational Therapy programme for patients with Alzheimer's disease with the impact of a one session consultation at home in German routine healthcare.DesignA seven-centre, parallel group, active controlled randomised controlled trial. Patients and carers were not masked. Assessors were fully blind for treatment allocation for one of two primary-outcome measurements.SettingPatients' homes.ParticipantsPatients with mild to moderate Alzheimer's disease (Mini-Mental State Examination 14-24), living in the community with primary carer available and without severe depression or behavioural symptoms, were eligible.InterventionsExperimental 10 home visits within 5 weeks by an occupational therapist, educating patients in the performance of simplified daily activities and in the use of aids to compensate for cognitive decline; and educating carers in coping with behaviour of the patient and in giving supervision to the patient. Control one home visit including individual counselling of patient and carer and explanation of a leaflet on coping with dementia in daily life.Outcome measuresThe primary outcome was the patient's daily functioning measured with the Interview of Deterioration in Daily activities in Dementia and the Perceive, Recall, Plan and Perform System of Task Analysis. Assessments were at baseline, 6, 16 and 26 weeks, with a postal assessment at 52 weeks.Results141 patients were 1:1 randomised to the experimental (N=71) and control group (N=70). Data for 54 and 50 participants were analysed. Patients' daily functioning did not differ significantly between the experimental and control group at week 6, 16, 26 or 52 and remained stable over 26 weeks in both groups. No adverse events were associated with the interventions.ConclusionsIn German healthcare, a Dutch 10-session community occupational therapy was not better than a one-session consultation for the daily functioning of patients with Alzheimer's disease. Further research on the transfer of complex psychosocial is needed. International Clinical Trials Registry Platform DRKS00000053; Funded by the German Federal Ministry of Health.

Dataset Information

The Effectiveness of Small-group Community-based Information Sessions on Clinical Trial Recruitment for Secondary Prevention of Alzheimer's Disease.

Publications

The Effectiveness of Small-group Community-based Information Sessions on Clinical Trial Recruitment for Secondary Prevention of Alzheimer's Disease.

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