The movement-to-music (M2M) study: study protocol for a randomized controlled efficacy trial examining a rhythmic teleexercise intervention for people with physical disabilities

Abstract Background People with physical disabilities need exercise routines that are enjoyable, readily available in the home, adapted to their functional level, and eliminate common barriers to exercise participation related to transportation and time commitment. The purpose of the movement-to-music (M2M) study is to address these issues by establishing a remotely delivered, rhythmic exercise program for people with physical disabilities. Methods The study is a two-arm randomized controlled efficacy trial examining a 12-week remotely delivered M2M intervention (eM2M) in 108 people with physical disabilities. The primary outcomes are changes in cardiorespiratory fitness and muscle strength at post 12-week intervention. Discussion The eM2M study will enhance our understanding of an alternative intervention design and delivery mode that removes common barriers to exercise participation experienced by people with physical disabilities. The eM2M intervention may be an alternative option for people with physical disabilities to obtain regular exercise, especially during a pandemic when exercising in indoor facilities may be problematic. Trial registration ClinicalTrials.gov NCT03797378. Registered on January 9, 2019, with the trial name “Movement-to-Music: Lakeshore Examination of Activity, Disability, and Exercise Response Study (M2M LEADERS)”.

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Telehealth Behavioral Intervention for Diabetes Management in Adults With Physical Disabilities: Intervention Fidelity Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.31695 ◽

2021 ◽

Author(s):

Ayse Zengul ◽

Eric Evans ◽

Allyson Hall ◽

Haiyan Qu ◽

Amanda Willig ◽

...

Keyword(s):

Artificial Intelligence ◽

Randomized Controlled Trial ◽

Behavior Change ◽

Diabetes Management ◽

Physical Disabilities ◽

Controlled Trial ◽

Health Coaching ◽

Intervention Fidelity ◽

Randomized Controlled ◽

People With Physical Disabilities

BACKGROUND Diabetes mellitus is a major health problem among people with physical disabilities. Health coaching has been proven to be an effective approach in terms of behavioral changes, patient self-efficacy, adherence to treatment, health service use, and health outcomes. Telehealth systems combined with health coaching have the potential to improve the quality of health care by increasing access to services. Treatment fidelity is particularly important for behavior change studies; however, fidelity protocols are inadequately administered and reported in the literature. OBJECTIVE The aim of this study is to outline all the intervention fidelity strategies and procedures of a telecoaching intervention—artificial intelligence for diabetes management (AI4DM)—which is a randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth platform in adults with type 2 diabetes and permanent impaired mobility. AI4DM aims to create a web-based disability-inclusive diabetes self-management program. We selected the National Institutes of Health Behavior Change Consortium (NIH BCC) fidelity framework to describe strategies to ensure intervention fidelity in our research. METHODS We have developed fidelity strategies based on the five fidelity domains outlined by the NIH BCC—focusing on study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. The design of the study is grounded in the social cognitive theory and is intended to ensure that both arms would receive the same amount of attention from the intervention. All providers will receive standardized training to deliver consistent health coaching to the participants. The intervention will be delivered through various controlling and monitoring strategies to reduce differences within and between treatment groups. The content and structure of the study are delivered to ensure comprehension and participation among individuals with low health literacy. By constantly reviewing and monitoring participant progress and protocol adherence, we intend to ensure that participants use cognitive and behavioral skills in real-world settings to engage in health behavior. RESULTS Enrollment for AI4DM will begin in October 2021 and end in October 2022. The results of this study will be reported in late 2022. CONCLUSIONS Developing and using fidelity protocols in behavior change studies is essential to ensure the internal and external validity of interventions. This study incorporates NIH BCC recommendations into an artificial intelligence embedded telecoaching platform for diabetes management designed for people with physical disabilities. The developed fidelity protocol can provide guidance for other researchers conducting telehealth interventions within behavioral health settings to present more consistent and reproducible research. CLINICALTRIAL ClinicalTrials.gov NCT04927377; http://clinicaltrials.gov/ct2/show/NCT04927377. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/31695

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Telehealth Behavioral Intervention for Diabetes Management in Adults With Physical Disabilities: Intervention Fidelity Protocol for a Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/31695 ◽

2021 ◽

Vol 10 (9) ◽

pp. e31695

Author(s):

Ayse Zengul ◽

Eric Evans ◽

Allyson Hall ◽

Haiyan Qu ◽

Amanda Willig ◽

...

Keyword(s):

Artificial Intelligence ◽

Randomized Controlled Trial ◽

Behavior Change ◽

Diabetes Management ◽

Physical Disabilities ◽

Controlled Trial ◽

Health Coaching ◽

Intervention Fidelity ◽

Randomized Controlled ◽

People With Physical Disabilities

Background Diabetes mellitus is a major health problem among people with physical disabilities. Health coaching has been proven to be an effective approach in terms of behavioral changes, patient self-efficacy, adherence to treatment, health service use, and health outcomes. Telehealth systems combined with health coaching have the potential to improve the quality of health care by increasing access to services. Treatment fidelity is particularly important for behavior change studies; however, fidelity protocols are inadequately administered and reported in the literature. Objective The aim of this study is to outline all the intervention fidelity strategies and procedures of a telecoaching intervention—artificial intelligence for diabetes management (AI4DM)—which is a randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth platform in adults with type 2 diabetes and permanent impaired mobility. AI4DM aims to create a web-based disability-inclusive diabetes self-management program. We selected the National Institutes of Health Behavior Change Consortium (NIH BCC) fidelity framework to describe strategies to ensure intervention fidelity in our research. Methods We have developed fidelity strategies based on the five fidelity domains outlined by the NIH BCC—focusing on study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. The design of the study is grounded in the social cognitive theory and is intended to ensure that both arms would receive the same amount of attention from the intervention. All providers will receive standardized training to deliver consistent health coaching to the participants. The intervention will be delivered through various controlling and monitoring strategies to reduce differences within and between treatment groups. The content and structure of the study are delivered to ensure comprehension and participation among individuals with low health literacy. By constantly reviewing and monitoring participant progress and protocol adherence, we intend to ensure that participants use cognitive and behavioral skills in real-world settings to engage in health behavior. Results Enrollment for AI4DM will begin in October 2021 and end in October 2022. The results of this study will be reported in late 2022. Conclusions Developing and using fidelity protocols in behavior change studies is essential to ensure the internal and external validity of interventions. This study incorporates NIH BCC recommendations into an artificial intelligence embedded telecoaching platform for diabetes management designed for people with physical disabilities. The developed fidelity protocol can provide guidance for other researchers conducting telehealth interventions within behavioral health settings to present more consistent and reproducible research. Trial Registration ClinicalTrials.gov NCT04927377; http://clinicaltrials.gov/ct2/show/NCT04927377. International Registered Report Identifier (IRRID) PRR1-10.2196/31695

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Home-based exercise program for older adults with Motoric Cognitive Risk syndrome: feasibility study

Neurodegenerative Disease Management ◽

10.2217/nmt-2020-0064 ◽

2021 ◽

Author(s):

Anne Felicia Ambrose ◽

Emma Gulley ◽

Tanya Verghese ◽

Joe Verghese

Keyword(s):

Older Adults ◽

Training Session ◽

Exercise Program ◽

Cognitively Impaired ◽

Exercise Participation ◽

Cognitive Risk ◽

Home Based ◽

Barriers To Exercise ◽

Telephonic Coaching ◽

Stretching Exercises

Aim: We developed a home-based goal-directed exercise program with telephonic coaching to overcome barriers to exercise participation in cognitively impaired older adults. Methods: Six patients with Motoric Cognitive Risk syndrome at high risk for dementia were enrolled, three assigned to goal-directed exercises and three to stretching exercises. All participants underwent an in-person training session followed by a session at home with a telephonic coach. Sessions were supervised by a physiatrist, and exercise programs were personalized. Results: In-person training and remote telephonic coaching support promoted adherence. There were no adverse effects and interventions were rated highly. Participant and logistical barriers were identified that can inform design of home-based clinical trials. Conclusion: Home-based exercises are safe and feasible in older adults with Motoric Cognitive Risk.

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