scholarly journals Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial

2016 ◽  
Vol 5 (2) ◽  
pp. e107 ◽  
Author(s):  
Raj Padwal ◽  
Finlay Aleck McAlister ◽  
Peter William Wood ◽  
Pierre Boulanger ◽  
Miriam Fradette ◽  
...  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
David Peter Neal ◽  
Yvonne J. F. Kerkhof ◽  
Teake P. Ettema ◽  
Majon Muller ◽  
Judith Bosmans ◽  
...  

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.


2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 811-811
Author(s):  
Jennifer Deal ◽  
Nicholas Reed ◽  
David Couper ◽  
Kathleen Hayden ◽  
Thomas Mosley ◽  
...  

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.


Trials ◽  
2013 ◽  
Vol 14 (1) ◽  
pp. 202 ◽  
Author(s):  
Hissei Imai ◽  
Toshiaki A Furukawa ◽  
Kiyohito Okumiya ◽  
Taizo Wada ◽  
Eriko Fukutomi ◽  
...  

Author(s):  
Jan A Overgaard ◽  
Thomas Kallemose ◽  
Kathleen K Mangione ◽  
Morten T Kristensen

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


2001 ◽  
Vol 36 (5) ◽  
pp. 249-255 ◽  
Author(s):  
Peter Huxley ◽  
Sherrill Evans ◽  
Tom Burns ◽  
Tom Fahy ◽  
John Green

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