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

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

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

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

scholarly journals Implementation and Evaluation of a Digitally Enabled Precision Public Health Intervention to Reduce Inappropriate Gabapentinoid Prescription: Cluster Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Andre Q Andrade ◽  
Jean-Pierre Calabretto ◽  
Nicole L Pratt ◽  
Lisa M Kalisch-Ellett ◽  
Gizat M Kassie ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavior Change ◽  
General Practitioners ◽  
Controlled Trial ◽  
Mode Of Delivery ◽  
Audit And Feedback ◽  
Professional Behavior ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Digital Delivery

BACKGROUND Digital technologies can enable rapid targeted delivery of audit and feedback interventions at scale. Few studies have evaluated how mode of delivery affects clinical professional behavior change and none have assessed the feasibility of such an initiative at a national scale. OBJECTIVE The aim of this study was to develop and evaluate the effect of audit and feedback by digital versus postal (letter) mode of delivery on primary care physician behavior. METHODS This study was developed as part of the Veterans’ Medicines Advice and Therapeutics Education Services (MATES) program, an intervention funded by the Australian Government Department of Veterans’ Affairs that provides targeted education and patient-specific audit with feedback to Australian general practitioners, as well as educational material to veterans and other health professionals. We performed a cluster randomized controlled trial of a multifaceted intervention to reduce inappropriate gabapentinoid prescription, comparing digital and postal mode of delivery. All veteran patients targeted also received an educational intervention (postal delivery). Efficacy was measured using a linear mixed-effects model as the average number of gabapentinoid prescriptions standardized by defined daily dose (individual level), and number of veterans visiting a psychologist in the 6 and 12 months following the intervention. RESULTS The trial involved 2552 general practitioners in Australia and took place in March 2020. Both intervention groups had a significant reduction in total gabapentinoid prescription by the end of the study period (digital: mean reduction of 11.2%, <i>P</i>=.004; postal: mean reduction of 11.2%, <i>P</i>=.001). We found no difference between digital and postal mode of delivery in reduction of gabapentinoid prescriptions at 12 months (digital: –0.058, postal: –0.058, <i>P</i>=.98). Digital delivery increased initiations to psychologists at 12 months (digital: 3.8%, postal: 2.0%, <i>P</i>=.02). CONCLUSIONS Our digitally delivered professional behavior change intervention was feasible, had comparable effectiveness to the postal intervention with regard to changes in medicine use, and had increased effectiveness with regard to referrals to a psychologist. Given the logistical benefits of digital delivery in nationwide programs, the results encourage exploration of this mode in future interventions.

scholarly journals The Effect of Health Coaching and Education on the Control of Type 2 Diabetes: A Randomized Controlled Trial

2022 ◽  
Vol 10 (1) ◽  
pp. 27-31
Author(s):  
Mona Hamdy Soliman ◽  
Roqaya Ali Alqahtani ◽  
Bashyer Alhothali ◽  
Soulaf Alsaeed ◽  
Soha Aly Elmorsy
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Health Coaching ◽  
Randomized Controlled

scholarly journals mHealth Technology and Nurse Health Coaching to Improve Health in Diabetes: Protocol for a Randomized Controlled Trial

2018 ◽  
Vol 7 (2) ◽  
pp. e45 ◽  
Author(s):  
Sheridan Miyamoto ◽  
Madan Dharmar ◽  
Sarina Fazio ◽  
Yajarayma Tang-Feldman ◽  
Heather M Young
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Health Coaching ◽  
Randomized Controlled ◽  
Mhealth Technology ◽  
Improve Health

scholarly journals Mechanisms of Action of a Web-Based Intervention With Health Professional Support to Increase Adherence to Nebulizer Treatments in Adults With Cystic Fibrosis: Qualitative Interview Study (Preprint)

2019 ◽  
Author(s):  
Sarah J Drabble ◽  
Alicia O'Cathain ◽  
Alexander J Scott ◽  
Madelynne A Arden ◽  
Samuel Keating ◽  
...  
Keyword(s):  
Cystic Fibrosis ◽  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Controlled Trial ◽  
Qualitative Interview ◽  
Mechanisms Of Action ◽  
Self Management ◽  
Randomized Controlled ◽  
Qualitative Interview Study ◽  
Adherence Data

BACKGROUND Adherence to nebulizer treatments in adults with cystic fibrosis (CF) is often low. A new complex intervention to help adults with CF increase their adherence to nebulizer treatments was tested in a pilot randomized controlled trial (RCT) in 2 UK CF centers. Patients used a nebulizer with electronic monitoring capabilities that transferred data automatically to a digital platform (CFHealthHub) to monitor adherence over time and to a tailored website to display graphs of adherence data and educational and problem-solving information about adherence. A trained interventionist helped patients identify ways to increase their adherence. OBJECTIVE This study aims to explore the mechanisms of action underpinning the intervention. METHODS A qualitative interview study was conducted concurrently with a pilot RCT. In total, 25 semistructured interviews were conducted with 3 interventionists at 2 time points, 14 patients in the intervention arm of the trial, and 5 members of the multidisciplinary teams offering wider care to patients. A framework approach was used for the analysis. RESULTS The intervention was informed by a theoretical framework of behavior change. There was evidence of the expected behavior change mechanisms of action. There was also evidence of additional mechanisms of action associated with effective telehealth interventions for self-management support: relationships, visibility, and fit. Patients described how building a relationship with the interventionist through face-to-face visits with someone who cared about them and their progress helped them to consider ways of increasing adherence to medication. Rather than seeing the visibility of adherence data to clinicians as problematic, patients found this motivating, particularly if they received praise about progress made. The intervention was tailored to individuals, but there were challenges in how the intervention fitted into some patients’ busy lives when delivered through a desktop computer. CONCLUSIONS The mechanisms of action associated with effective telehealth interventions for self-management operated within this new intervention. The intervention was modified to strengthen mechanisms of action based on these findings, for example, delivery through an app accessed via mobile phones and then tested in an RCT in 19 UK CF centers. CLINICALTRIAL International Standard Randomized Controlled Trial Number 13076797; http://www.isrctn.com/ISRCTN13076797

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