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

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.

scholarly journals Mindfulness Awareness Practice (MAP) to Prevent Dementia in Older Adults with Mild Cognitive Impairment: Protocol of a Randomized Controlled Trial and Implementation Outcomes

2021 ◽  
Vol 18 (19) ◽  
pp. 10205
Author(s):  
Ted Kheng Siang Ng ◽  
Lei Feng ◽  
Johnson Fam ◽  
Iris Rawtaer ◽  
Alan Prem Kumar ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Cognitive Decline ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Randomized Controlled ◽  
Community Dwelling Older Adults

Background: With an aging population, developing non-pharmacological interventions (NPIs) to delay dementia has become critical. Apart from cognitive decline, dementia is associated with multiple pathophysiology, including increased oxidative stress, dysregulated gene expressions, cytokine, neurotrophin, and stress markers, telomere shortening, and deteriorations in brain connectivity. Although mindfulness practices have been proposed to ameliorate these biological changes, no empirical studies were conducted. We thus aimed to investigate the effects of mindfulness awareness practice (MAP) to prevent cognitive decline and improve peripheral biomarkers in community-dwelling older adults diagnosed with mild cognitive impairment (MCI). Methods/Design: This was a single-blinded and parallel-group randomized controlled trial with two arms (intervention and active control arms), conducted over nine months. A total of 60 consenting community-dwelling older adults diagnosed with MCI were planned to be randomized in a 1:1 ratio to either the MAP or the Health Education Program (HEP). Interventions were performed weekly for the initial 12 weeks, and monthly for the subsequent six months. Outcome measures were assessed at baseline, 3-month, and 9-month post-intervention by blinded assessors. Primary outcomes were neurocognitive tests, comprehensive peripheral biomarkers, and brain imaging scans. Secondary outcomes included basic health screening measures, affective symptoms, and measures of physical functions. Linear-mixed models were used to examine the effects of MAP on these outcome measures. Significance: This is the first randomized controlled trial to systematically investigate the effects of a mindfulness intervention in improving cognitive functions and various biomarkers in community-dwelling older adults diagnosed with MCI. Our findings have the potential to inform mindfulness intervention as a novel approach to delay dementia.

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

Trials ◽  
2013 ◽  
Vol 14 (1) ◽  
pp. 202 ◽  
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

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

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

Feasibility randomized controlled trial of a mind-body activity program for older adults with chronic pain and cognitive decline: The virtual “Active Brains” study

2021 ◽  
Author(s):  
James D Doorley ◽  
Ryan A Mace ◽  
Paula J Popok ◽  
Victoria A Grunberg ◽  
Anya Ragnhildstveit ◽  
...  
Keyword(s):  
Older Adults ◽  
Chronic Pain ◽  
Randomized Controlled Trial ◽  
Cognitive Decline ◽  
Controlled Trial ◽  
A Priori ◽  
Exit Interviews ◽  
Randomized Controlled ◽  
Activity Program ◽  
Body Activity

Abstract Background and Objectives Chronic pain (CP) and cognitive decline (CD) are highly co-morbid and debilitating among older adults. We iteratively developed Active Brains–Fitbit (AB-F), a group mind-body activity program aided by a Fitbit that is feasible and associated with improvements in physical, cognitive, and emotional functioning when delivered in person to older adults with CP and CD. We adapted our intervention and methodology for remote delivery to bypass barriers to participation. Here we report on a feasibility randomized controlled trial of the virtual AB-F versus a Health Enhancement Program (HEP) educational control followed by qualitative exit interviews. Research Design and Methods Older adults (age ≥ 60) with CP and CD (2 cohorts) completed eight weeks of AB-F (n = 8) or HEP (n = 11). Study procedures were fully remote via live video. Quantitative analyses explored feasibility and acceptability markers and within group improvements in outcomes. Qualitative analyses were primarily deductive using the Framework Method. Results AB-F met a-priori set feasibility benchmarks, similar to our in-person pilot. Participation in AB-F was associated with preliminary signals of improvement in multimodal physical function, emotional function (anxiety), cognitive function, pain intensity, and coping (e.g., pain self-efficacy, catastrophizing). Participation in HEP was associated with smaller or negligible improvements. Exit interviews confirmed feasibility and satisfaction with our completely remote interventions and methodology. Discussion and Implications Results provide evidence for the feasibility of our completely remote study, and for initial markers of improvement after AB-F. The results will inform a fully powered remote efficacy trial.

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

2018 ◽  
Vol 18 (1) ◽  
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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