Clinical trial NCT04710940: Development and Feasibility Testing of DM-BOOST Intervention.
Official title: Development and Feasibility Testing of a Diabetes Mellitus Program Using Behavioral Economics to Optimize Outreach and Self-management Support With Technology.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Worcester Polytechnic Institute
First posted: 2021-01-15
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The purpose of this study is to develop and usability test a patient-centric intervention designed to improve implementation of diabetes self-management training. To accomplish this, 3 specific aims will be completed.

Aim 1 - Retrospective data from the UMass Medical School EHR data repository will be analyzed to identify different clusters of patients with diabetes.

Aim 2 - To facilitate a patient-centric design of the DM-BOOST intervention, Patient Research Expert Panel (PREP) members (n\</=10) will be recruited from various patient types identified in Aim 1 (Aim 2a), participate in Community Engagement Studios to inform intervention conceptualization (Aim 2b) and usability test the intervention (Aim 2c).

Aim 3 - The intervention will be pilot tested in n\</=70 patients with type 2 diabetes (T2D). Participants will be randomized to either intervention or comparison groups.
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Intervention Acceptability (Aim 2)
timeFrame: 1 month
measure: Completion of diabetes self-management training (Aim 3)
timeFrame: 9 months
Secondary outcomes:
measure: Clinical utilization (Aim 3)
timeFrame: 9 months
measure: Diabetes self-efficacy (Aim 3)
timeFrame: 3 months
measure: Diabetes treatment satisfaction (Aim 3)
timeFrame: 3 months
measure: Diabetes self-management skills (Aim 3)
timeFrame: 3 months
measure: Patient engagement with Diabetes Self-Management Training (Aim 3)
timeFrame: 9 months
measure: Hemoglobin A1C (HbA1C) (Aim 3)
timeFrame: 6 months
Other outcomes:
measure: Predictors of guideline-concordant diabetes care (sociodemographic predictors) (Aim 1)
timeFrame: Assessed at baseline
measure: Predictors of guideline-concordant diabetes care (HbA1c level) (Aim 1)
timeFrame: Assessed at baseline
measure: Predictors of guideline-concordant diabetes care (BMI) (Aim 1)
timeFrame: Assessed at baseline
measure: Predictors of guideline-concordant diabetes care (Smoking Status) (Aim 1)
timeFrame: Assessed at baseline
measure: Predictors of guideline-concordant diabetes care (Cholesterol level) (Aim 1)
timeFrame: Assessed at baseline
measure: Predictors of guideline-concordant diabetes care (Clinical utilization) (Aim 1)
timeFrame: Assessed at baseline
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Daniel J Amante, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: