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Clinical Trials/NCT04710940
NCT04710940
Completed
Not Applicable

Development and Feasibility Testing of a Diabetes Mellitus Program Using Behavioral Economics to Optimize Outreach and Self-management Support With Technology.

Daniel Amante1 site in 1 country66 target enrollmentJanuary 13, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
Daniel Amante
Enrollment
66
Locations
1
Primary Endpoint
Completion of diabetes self-management training (Aim 3)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

DM-BOOST uses clinical informatics tools to identify types of patients with gaps in diabetes care and deploy tailored, proactive outreach methods rooted in behavioral economics to nudge them towards increased engagement with diabetes self-management training and leverage patient-facing technologies to enhance longitudinal patient self-management support.

Detailed Description

In DM-BOOST, the Principal investigator will deploy a mixed-methods, patient-centered approach to intervention development and initiate a multiphase optimization strategy (MOST) to learn how to maximize patient engagement and support of self-management training. In this pilot, study team will complete the first phase (Preparation), and initiate feasibility piloting of the second phase (Optimization). Completion of optimization and MOST's final phase (Evaluation), will occur in a subsequent project. In the preparation phase, Principal investigator will first analyze EHR and claims data in the UMCCTS data lake to identify sociodemographic characteristics associated with gaps in diabetes care to develop patient persona archetypes (Aim 1). Next, Principal investigator will selectively recruit patients of identified persona types as consultants, elicit stakeholder feedback during community engagement studios and conduct usability testing to iteratively design the intervention (Aim 2). Study team will then conduct a feasibility pilot (Aim 3) to assess user experience of the intervention implementation and collect exploratory outcome data to be used to inform a subsequent, complete optimization trial.

Registry
clinicaltrials.gov
Start Date
January 13, 2021
End Date
January 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Daniel Amante
Responsible Party
Sponsor Investigator
Principal Investigator

Daniel Amante

Assistant Professor

University of Massachusetts, Worcester

Eligibility Criteria

Inclusion Criteria

  • Adults (age 18+)
  • Cognitively able to consent (Aims 2 and 3)
  • Diagnosed with type 2 diabetes (Aims 1-3)
  • Receive primary care at UMMHC in past 12 months at time of initial analysis (Aims 1-3)
  • English speaking (Aims 2 and 3)
  • Have access to patient portal or a smart phone (Aim 3)

Exclusion Criteria

  • Adults unable to consent (lacking cognitive capacity) (Aims 2 and 3)
  • Individuals who are not yet adults (infants, children, teenagers) (Aims 1-3)
  • Pregnant women (Aims 1-3)
  • Prisoners (Aims 1-3)
  • Non-English speaking (Aims 2 and 3)

Outcomes

Primary Outcomes

Completion of diabetes self-management training (Aim 3)

Time Frame: 9 months

Completion of diabetes self-management training.

Intervention Acceptability (Aim 2)

Time Frame: 1 month

Patient-reported assessment of intervention acceptability via usability testing. Qualitative data collection informed by the Technology Acceptance Model with assessment of perceived usefulness, ease of use, behavioral intention to use and external factors. No quantitative data measured.

Secondary Outcomes

  • Clinical utilization (Aim 3)(9 months)
  • Diabetes self-efficacy (Aim 3)(3 months)
  • Diabetes treatment satisfaction (Aim 3)(3 months)
  • Diabetes self-management skills (Aim 3)(3 months)
  • Hemoglobin A1C (HbA1C) (Aim 3)(6 months)
  • Patient engagement with Diabetes Self-Management Training (Aim 3)(9 months)

Study Sites (1)

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