Clinical trial NCT05344859: GODART Pilot and Feasibility
Official title: A Feasibility and Pilot Trial of Gamification and AI-based Health Coaching Intervention Components for Diabetes Management Using the GODART Platform
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: We propose to use the multiphase optimization strategy (MOST) design, as an ideal approach for the study, that is based on the principle of resource management and continuous improvement. Our study aim aligns with the preparatory and optimization phases of MOST, and is structured to serve as the preparatory phase for a future large-scale MOST optimization phase.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to pilot and assess the feasibility of implementing an artificial intelligence-assisted individualized lifestyle modification intervention for glycemic control in rural populations, which can be delivered even with regular landline phone service. This study will provide us with the knowledge to plan a well-powered optimization trial in the future to develop an optimal (low-cost) intervention package that can be delivered in a sustainable manner to the rural portions of America.

Detailed description: Evidence-based guidelines for type 2 diabetes mellitus (T2DM) management aimed at glycemic control (reduced hemoglobin A1c) include a combination of diet, physical activity (PA), glucose monitoring, and medication adherences. However, the majority of individuals with T2DM are unable to follow these guidelines due to a lack of consistent health behavior counseling offered in the primary care setting. This problem is amplified in remote rural communities within the U.S. In response, this project aims to create an optimized telehealth-based intervention - Gamified Optimized Diabetes management with Artificial Intelligence-powered Rural Telehealth (GODART). GODART is grounded in the social cognitive theory and will serve as an automated behavior-monitoring and telecoaching platform. At the core, GODART is an automated conversational-style behavior-monitoring system using natural language-understanding technologies. In this project, we propose to pilot and feasibility test the various components of GODART by leveraging a multiphase optimization strategy (MOST). MOST is an efficient and rigorous resource-management and continuous- improvement framework for developing optimized interventions. Our proposal focuses on the MOST preparatory phase and will use full factorial experimentation. We will pilot and assess the feasibility of and evaluate two different intervention components, with two levels in each of the groups, yielding four experimental conditions. These groups will test the effect of (i) a fixed vs. adaptive (gamified) rewards program and (ii) automated vs. human-delivered weekly health coaching. We will end the project with exit interviews conducted with a subset of participants. Study findings will help us learn the feasibility of delivering such an intervention and its preliminary effectiveness in reducing HbA1c, leading to adequately powered confirmatory effectiveness studies.

Participants will be enrolled in the study in 2 phases:

Phase 1-The Feasibility Phase: Up to 16 participants will be enrolled in this phase of the study. Participants will be in the study for a duration of 14 days. This phase of the study is conducted to access the feasibility, usability, and accessibility of the GODART platform, before the actual intervention phase.

Phase 2- Intervention Phase: 88 participants will be enrolled in this phase of the study for a duration of 6 months.

Eligibility criteria: Inclusion Criteria:

1. a diagnosis of T2DM
2. HbA1C ≥7% to ≤ 10.5% for phase 1- 14 days and phase 2 of the study- 6 months.
3. ≥18 years of age
4. the ability to converse in and read English.

Exclusion Criteria:

1. Present or soon-planned pregnancy
2. Current enrollment in any structured lifestyle intervention study for diabetes or weight management.
3. Patients currently on insulin treatment
4. Major cardiac event in the past 6 months
5. Renal failure in the past 6 months
6. Listening and Speaking Impairment

Primary outcomes:
measure: Change in Hemoglobin A1C level between screening and 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Department of Family and Community Medicine, University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Tapan Mehta, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Mohanraj Thirumalai, PHD
role: PRINCIPAL_INVESTIGATOR
References: