Effects of exercise and nutrition supplementation in community-dwelling older Chinese people with sarcopenia: a randomized controlled trial

Abstract Background For the rising number of people living with dementia, cost-effective community-based interventions to support psychosocial care are needed. The FindMyApps intervention has been developed with and for people with dementia and their caregivers, to help them use tablets to facilitate self-management and engagement in meaningful social activities. A feasibility study and exploratory pilot trial evaluating FindMyApps have been carried out. This definitive trial further evaluates the effectiveness of the intervention and, for the first time, the cost-effectiveness. Methods A randomized controlled non-blinded single-center two-arm superiority trial will be conducted. Community-dwelling people with Mild Cognitive Impairment (MCI), or dementia with a Mini Mental-State Examination (MMSE) of > 17 and < 26, or Global Deterioration Scale 3 or 4, with an informal caregiver and access to a wireless internet connection will be included. In total, 150 patient-caregiver dyads will be randomly allocated to receive either usual care (control arm – tablet computer; n = 75 dyads) or usual care and the FindMyApps intervention (experimental arm – tablet computer and FindMyApps; n = 75 dyads). The primary outcomes are: for people with dementia, self-management and social participation; for caregivers, sense of competence. In addition to a main effect analysis, a cost-effectiveness analysis will be performed. In line with MRC guidance for evaluation of complex interventions a process evaluation will also be undertaken. Discussion Results of the trial are expected to be available in 2023 and will be submitted for publication in international peer-reviewed scientific journals, in addition to conference presentations and reporting via the EU Marie Sklodowska-Curie DISTINCT ITN network. By providing evidence for or against the effectiveness and cost-effectiveness of the FindMyApps intervention, the results of the trial will influence national implementation of FindMyApps. We hope that the results of the trial will further stimulate research and development at the intersection of technology and psycho-social care in dementia. We hope to further demonstrate that the randomized controlled trial is a valuable and feasible means of evaluating new digital technologies, to stimulate further high-quality research in this growing field. Trial registration number Netherlands Trial Register: NL8157; registered 15th November 2019.

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The ACHIEVE Trial: Lessons Learned From Nesting a Randomized Controlled Trial Within an Observational Cohort Study

Innovation in Aging ◽

10.1093/geroni/igaa057.2950 ◽

2020 ◽

Vol 4 (Supplement_1) ◽

pp. 811-811

Author(s):

Jennifer Deal ◽

Nicholas Reed ◽

David Couper ◽

Kathleen Hayden ◽

Thomas Mosley ◽

...

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Observational Study ◽

Cognitive Decline ◽

Controlled Trial ◽

Lessons Learned ◽

Community Dwelling ◽

Randomized Controlled ◽

Study Staff ◽

Increased Risk

Abstract Hearing impairment in older adults is linked to accelerated cognitive decline and a 94% increased risk of incident dementia in population-based observational studies. Whether hearing treatment can delay cognitive decline is unknown but could have substantial clinical and public health impact. The NIH-funded ACHIEVE randomized controlled trial of 977 older adults aged 70-84 years with untreated mild-to-moderate hearing loss, is testing the efficacy of hearing treatment versus health education on cognitive decline over 3 years in community-dwelling older adults (Clinicaltrials.gov Identifier: NCT03243422.) This presentation will describe lessons learned from ACHIEVE’s unique study design. ACHIEVE is nested within a large, well-characterized multicenter observational study, the Atherosclerosis Risk in Communities Study. Such nesting within an observational study maximizes both operational and scientific efficiency. With trial results expected in 2022, this presentation will focus on the benefits gained in design and recruitment/retention, including dedicated study staff, well-established protocols, and established study staff-participant relationships. Part of a symposium sponsored by Sensory Health Interest Group.

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The postcard intervention against depression among community-dwelling older adults: study protocol for a randomized controlled trial

Trials ◽

10.1186/1745-6215-14-202 ◽

2013 ◽

Vol 14 (1) ◽

pp. 202 ◽

Cited By ~ 2

Author(s):

Hissei Imai ◽

Toshiaki A Furukawa ◽

Kiyohito Okumiya ◽

Taizo Wada ◽

Eriko Fukutomi ◽

...

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Study Protocol ◽

Controlled Trial ◽

Community Dwelling ◽

Randomized Controlled ◽

Community Dwelling Older Adults

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Six Versus 12 Weeks of Outpatient Physical Therapy Including Progressive Resistance Training in Cognitively Intact Older Adults After Hip Fracture: A Multicenter Randomized Controlled Trial

The Journals of Gerontology Series A ◽

10.1093/gerona/glab256 ◽

2021 ◽

Author(s):

Jan A Overgaard ◽

Thomas Kallemose ◽

Kathleen K Mangione ◽

Morten T Kristensen

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Hip Fracture ◽

Physical Therapy ◽

Controlled Trial ◽

Community Dwelling ◽

Walking Distance ◽

Randomized Controlled ◽

Multicenter Randomized Controlled Trial ◽

Cognitively Intact

Abstract Background Recovery of function and regaining muscle strength are challenging after hip fracture. We compared the effectiveness of a 12- versus 6-week outpatient physical therapy program with progressive resistive training (PRT) to increase strength and physical performance. Methods This parallel, superiority, 2-group randomized controlled trial was conducted in 4 clinics that enrolled community-dwelling, cognitively intact older adults (+60 years) with a surgical repair of a hip fracture and no major medical conditions. Participants received 12 or 6 weeks of PRT and standardized physical therapy, twice weekly. Pain was monitored throughout. Primary outcome was the change in the 6-minute walk test (6MWT) from baseline to 12-week follow-up. Randomization via a computer-generated allocation sequence was implemented using sealed, sequentially numbered opaque envelopes and assessors were blinded to group assignment. Results Participants (81% women) with a mean (SD) age of 77 (8.1) years were enrolled at an average of 18 days after hip fracture surgery and randomized into a 12-week group (n = 50) or a 6-week group (n = 50). Mean (SD) change scores in the 6MWT were 143.8 (81.1) and 161.5 (84.1) m in the 12- and 6-week groups, respectively (both exceeding the minimal clinically important difference of 55 m). The mean between-group difference was −17.7 m (95% CI −50.1, 14.8). Pain during training did not exceed moderate levels nor increase as training intensity increased. Conclusion Twelve weeks of physical therapy with PRT was not superior to 6 weeks in improving walking distance. Hip fracture-related pain was relatively low and indicated strength testing and training was well tolerated. Clinical Trials Registration Number: NCT01174589

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A randomized controlled trial of the effects of a comprehensive intervention program for community-dwelling older adults

Nippon Ronen Igakkai Zasshi Japanese Journal of Geriatrics ◽

10.3143/geriatrics.48.352 ◽

2011 ◽

Vol 48 (4) ◽

pp. 352-360 ◽

Cited By ~ 5

Author(s):

Ryota Sakurai ◽

Yoshinori Fujiwara ◽

Hunkyung Kim ◽

Kyoko Saito ◽

Masashi Yasunaga ◽

...

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Intervention Program ◽

Controlled Trial ◽

Community Dwelling ◽

Randomized Controlled ◽

Comprehensive Intervention ◽

Community Dwelling Older Adults

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Randomized controlled trial to evaluate a prevention program for frail community-dwelling older adults: a D-SCOPE protocol

BMC Geriatrics ◽

10.1186/s12877-018-0875-3 ◽

2018 ◽

Vol 18 (1) ◽

Cited By ~ 4

Author(s):

Deborah Lambotte ◽

Liesbeth De Donder ◽

Ellen E. De Roeck ◽

Lieve J. Hoeyberghs ◽

Anne van der Vorst ◽

...

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Prevention Program ◽

Controlled Trial ◽

Community Dwelling ◽

Randomized Controlled ◽

Community Dwelling Older Adults

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Use and effect of web-based embodied conversational agents for improving eating behavior and decreasing loneliness among community-dwelling older adults: A randomized controlled trial (Preprint)

10.2196/preprints.33974 ◽

2021 ◽

Author(s):

Lean L. Kramer ◽

Lex van Velsen ◽

Jenna L. Clark ◽

Bob C. Mulder ◽

Emely de Vet

Keyword(s):

Older Adults ◽

Randomized Controlled Trial ◽

Eating Behavior ◽

Controlled Trial ◽

Community Dwelling ◽

Embodied Conversational Agents ◽

Conversational Agents ◽

Web Based ◽

Randomized Controlled ◽

Community Dwelling Older Adults

BACKGROUND Embodied conversational agents (ECAs) have been proposed as a promising interaction modality for the delivery of programs focused on promoting lifestyle changes. However, it is not understood which factors influence use of an ECA and their health effects. OBJECTIVE We aim to (1) identify whether ECAs can persuade community-dwelling older adults to change their dietary behavior and whether ECAs use can decrease loneliness, (2) test these pathways to effects, and (3) understand the use of an ECA. METHODS The web-based eHealth app PACO is a fully automated 8-week intervention in which 2 ECAs engage older adults in dialogue to motivate them to change their dietary behavior and decrease their loneliness. PACO was developed via a human-centered and stakeholder-inclusive design approach and incorporates Self-determination Theory and various behavior change techniques For this study, an unblinded web-based randomized controlled trial was conducted. Participants were recruited via social media, an online panel, flyers and advertorials. The intervention group received access to the PACO service for eight weeks. The waitlist group received PACO after waiting for four weeks. The primary outcomes, eating behavior and loneliness, were assessed via self-assesed online questionnaires at intake, waitlist, after 4 weeks, and after eight weeks. In addition, the primary outcome—use—was assessed via data logs. Secondary outcomes were measured at the same times, via questionnaires or an optional interview. RESULTS In total, 32 participants completed the intervention. We found a significant correlation between use in minutes on the one hand, and perceived usefulness (r = .39, P =.030) and enjoyment on the other (r = .38, P = .032). However, these did not predict use in the full regression model (F(2,29) = 1.98, P = .16, R2 = .12). Additionally, PACO use did not lead to improvements in eating behavior (χ2(2) = .34, = .85) or a decrease in loneliness (χ2(2) = .02, = .99). CONCLUSIONS Our study did not provide any concluding evidence about factors that are linked to the use or health effects of ECAs. Future service design could benefit from either creating a functional design catered towards the predominant stage of the targeted population, or by personalizing the service based on an intake in which the end-user’s stage is determined. CLINICALTRIAL ClinicalTrials.gov NCT04510883; https://clinicaltrials.gov/ct2/show/NCT04510883 INTERNATIONAL REGISTERED REPORT RR2-10.2196/22186

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