Promoting activity, Independence and stability in early dementia (PrAISED): a, multisite, randomised controlled, feasibility trial

Abstract

BackgroundWe tested the feasibility of delivering and evaluating a complex therapy intervention which aimed to promote activity and independence for people with early dementia (PrAISED). Feasibility questions were on: recruitment, randomisation, intervention delivery, adherence and withdrawals, level of supervision required, adverse events, data collection and sample size assumptions.MethodsWe conducted a three-arm, multi-site, single-blind, randomised controlled feasibility trial. Eligibility criteria were aged 65 years or older, diagnosed mild dementia or mild cognitive impairment, able to walk without human help, and communicate in English, no co-morbidities that prevented participation in cognitive assessment and capacity to give consent. Participants were recruited from Memory Assessment Service clinics and the ‘Join Dementia Research’ register.Patient participants were randomised 1:1:1 to a high intensity supervision PrAISED intervention, moderate intensity supervision PrAISED intervention or brief falls prevention assessment and advice (control). The PrAISED intervention aimed for participants to complete three hours of PrAISED exercises a week for 12 months. It included individualised activity and exercise plans and supervised exercises with regular re-assessment and progression, and was delivered by occupational therapists, physiotherapists and rehabilitation support workers. Primary efficacy outcome was the Disability Assessment for Dementia (DAD), measured after 12 months. Secondary outcomes included physical activity, quality of life, mood, cognition, strength, balance, rate of falls, frailty and carer strain. Falls and activity were ascertained by monthly diary.ResultsBetween September 2016 and March 2017 we recruited 60 patient participants and 54 carer participants from two sites. Forty-nine patient participants completed a follow-up interview. Feasibility outcomes were mostly satisfactory, including recruitment and retention, intervention delivery and data completeness for most scales used. We could not maintain blinding of researchers at follow-up and experienced difficulties collecting data using some questionnaires and devices. Participants only completed a mean 77 (moderate supervision) and 71 (high supervision) minutes per week of PrAISED exercises over 12 months. We recorded 19 adverse events, none serious and related to the intervention.ConclusionWe conclude that with some adjustments to the trial protocol, it is feasible to deliver the PrAISED intervention and conduct a trial.Trial registrationClinicalTrials.gov: NCT02874300 (first posted 22nd August 2016), ISRCTN: 10550694 (date assigned 31st August 2016).

Implementing an Online Virtual Falls Prevention Intervention During a Public Health Pandemic for Older Adults with Mild Cognitive Impairment: A Feasibility Trial

“…These findings are largely consistent with our prior work 17,18 and with the work of others who have focused on other types of exercise intervention programs targeting older adults with cognitive impairment. [31][32][33] The findings, however, contrast with a previous Tai Ji Quan intervention study that ran for a similar length of time (6 months) but showed no significant impact on the Timed Up and Go Test. 34 Although there has been an increasing number of falls prevention trials targeting community-dwelling older adults with cognitive impairment, 13 ours is the first that focuses on evaluating a dual-task intervention specifically targeted at older adults with MCI, a precursor to ADRD.…”

Applying the RE-AIM implementation framework to evaluate fall prevention interventions in community dwelling adults with cognitive impairment: A review 

“…The majority of studies (n = 8) were exercise interventions (31)(32)(33)(34)(35)(36)(37)(38), while 3 were multifactorial (5,39,40), and 1 provided medication treatment (41). Five of the 12 included studies were self-described as "feasibility" studies (5,31,32,36,37). Overall, the studies were published from 2010 to 2020.…”

“…Adoption is speci cally segmented at two levels, setting and staff, while Maintenance has criteria that relate to both individual and organizational level. Only one intervention was delivered at multiple sites and it was not designed to test or measure implementation at different sites based on these criteria (32). Not knowing differences in settings and providers makes it di cult to determine what criteria might be needed for a site to successfully deliver the intervention, who in a real-world setting is best suited to deliver the intervention, or what settings might be appropriate for translation.…”

“…Overall, participant attendance or completion rates and qualitative measures of implementation were not well reported by studies. Additionally, only 4 studies speci ed a theory or framework that informed the development of the intervention and while no studies stated involvement of participants or caregivers in designing the intervention, 4 studies did include caregivers in implementation of intervention components (5,32,33,37). Additionally, four studies purposefully tailored their intervention methods and delivery to the individual participants in their study through individual activity/exercise plans that may have been adjusted for age, illness-related de cits, and/or tailored and specialized programming.…”

“…The 4 criteria reported by all studies were participant characteristics, sample size, and intervention details, consistent with CONSORT guidelines (42). Five of the included studies reported on 20 or more of the 62 possible RE-AIM criteria (5,32,33,37,39) and three of these studies were ones that self-identi ed as "feasibility" studies (5,32,37). The study that reported the most criteria (23 out of 62) was a randomized trial to test the feasibility of study components and acceptability of a home hazard reduction and balance and strength exercise fall prevention program (5).…”