Development and Feasibility Testing of DM-BOOST Intervention.

NCT04710940 | Completed

• 1 other identifier: H00017902
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Intervention Acceptability (Aim 2)

  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.

  1 month

• Completion of diabetes self-management training (Aim 3)

  Completion of diabetes self-management training.

  9 months

Secondary Outcomes (6)

• 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

• Patient engagement with Diabetes Self-Management Training (Aim 3)

  9 months

Other Outcomes (6)

• Predictors of guideline-concordant diabetes care (sociodemographic predictors) (Aim 1)

  Assessed at baseline

• Predictors of guideline-concordant diabetes care (HbA1c level) (Aim 1)

  Assessed at baseline

• Predictors of guideline-concordant diabetes care (BMI) (Aim 1)

  Assessed at baseline

Study Arms (2)

Intervention - Diabetes BOOST

EXPERIMENTAL

Intervention group participants will complete a baseline survey, receive a referral to DSMT from the research team, a mailed welcome letter and self-care education sent via a series of personalized patient portal secure messages, text messages, and video call. They will be sent text messages with information about one of the American Association of Diabetes Educators 7 self-care behaviors and will receive encouragement to author their own self-management behavioral goals. Participants will also complete a telehealth training video call with research staff and review the goals that the participant replied with. The participant will then be encouraged to send a patient portal message to their DSMT CDCES that includes their personalized goals prior to their scheduled DSMT session. They will then complete a 3-month follow-up survey and qualitative interview.

Behavioral: Diabetes BOOST

Usual Care

ACTIVE COMPARATOR

Comparison Group participants will complete a baseline survey, receive a DSMT referral request from research team to their primary care provider and a mailed welcome letter. The mailed letter will welcome the participant to the study and contain general information about diabetes self-care behaviors and goal setting. They will complete a DSMT session. They will then complete a 3-month follow-up survey and qualitative interview.

Behavioral: Usual Care

Interventions

Diabetes BOOST BEHAVIORAL

Participants will receive supportive care using technology for DSMT in addition to usual care.

Intervention - Diabetes BOOST

Usual Care BEHAVIORAL

Participants will receive usual care for DSMT.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Daniel Amante: lead
• Worcester Polytechnic Institute: collaborator

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Daniel J Amante, PhD, MPH

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: After completing the informed consent, study staff will enter the participant's information into pre-populated REDCap identification numbers. This will assign allocation based on the randomization table. Using this technique, participants will be blinded to allocation. However, research staff will not be blinded to provide personalized training for intervention and control. The investigator will be blinded to randomization for all participants during the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: January 15, 2021
• Study Start: January 13, 2021
• Primary Completion: November 1, 2022
• Study Completion: January 1, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)