JMIR Publications

ABSTRACT

Background:

Diabetes Mellitus is a major health problem among people with physical disabilities. Health coaching has been proven as an effective approach in terms of behavior changes, patient self-efficacy, adherence to treatment, health service utilization 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:

This study outlines all the intervention fidelity strategies and procedures of a telecoaching intervention Artificial Intelligence for Diabetes Management (AI4DM), which is a randomized control trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth platform in adults with Type 2 Diabetes (T2D) and permanent impaired mobility. AI4DM aims to create an online disability-inclusive diabetes self-management program. We selected the National Institutes of Health Behavior Change Consortium (NIH BCC) fidelity framework to describe strategies to assure intervention fidelity in our research.

Methods:

We have developed the 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 social cognitive theory and 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 for participants. The intervention will be delivered through various controlling and monitoring strategies to reduce differences within/between treatment groups. The content and structure of the study are delivered to ensure comprehension and participation among low health literacy individuals. By constantly reviewing and monitoring participant progress and protocol adherence, we intend to ensure participants use cognitive and behavioral skills in real-world settings to engage in health behavior.

Results:

Enrolment for AI4DM begins in August 2021 and will end in August 2022. The results of the study will be reported in late 2022.

Conclusions:

Developing and utilizing fidelity protocols in behavior change studies is essential to ensure the internal and external validity of the interventions. This study incorporated 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. Clinical Trial: ClinicalTrials.gov: NCT04927377