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Behavioural Intervention

Diabetes Management Intervention for Diabetes (DM-BOOST Trial)

N/A

Waitlist Available

Led By Daniel J Amante, PhD, MPH

Research Sponsored by Daniel Amante

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

DM-BOOST Trial Summary

This trial uses clinical informatics tools to find patients with gaps in their diabetes care, and then uses personalized outreach methods and technologies to help them manage their diabetes better.

Who is the study for?

This trial is for adults over 18 with type 2 diabetes who have seen their primary care doctor at UMMHC in the past year. Participants must be able to consent, speak English, and have access to a patient portal or smartphone.Check my eligibility

What is being tested?

DM-BOOST intervention is being tested against usual care for type 2 diabetes. It uses clinical informatics to identify patients needing better diabetes management and employs behavioral tactics plus technology for ongoing support.See study design

What are the potential side effects?

Since DM-BOOST primarily involves information tools and self-management training rather than medication, it may not have typical drug side effects but could include stress or anxiety from lifestyle changes.

DM-BOOST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Completion of diabetes self-management training (Aim 3)

Intervention Acceptability (Aim 2)

Secondary outcome measures

Clinical utilization (Aim 3)

Diabetes self-efficacy (Aim 3)

Diabetes self-management skills (Aim 3)

+3 more

Other outcome measures

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

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

Predictors of guideline-concordant diabetes care (Clinical utilization) (Aim 1)

+3 more

DM-BOOST Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention - Diabetes BOOSTExperimental Treatment1 Intervention

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.

Group II: Usual CareActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diabetes BOOST

2021

N/A

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Daniel AmanteLead Sponsor

1 Previous Clinical Trials

70 Total Patients Enrolled

Worcester Polytechnic InstituteOTHER

16 Previous Clinical Trials

29,813 Total Patients Enrolled

Daniel J Amante, PhD, MPHPrincipal InvestigatorUMass Medical School

1 Previous Clinical Trials

70 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there presently any open opportunities to volunteer for this trial?

"Confirmed. According to clinicaltrials.gov, this research is currently seeking volunteers and was first published on January 13th 2021 before being last modified on September 13th 2022. 70 individuals are required for the trial at one location."

Answered by AI

What is the ultimate purpose of this medical experiment?

"This nine-month clinical trial will assess the Intervention Acceptability (Aim 2) of patients, with secondary objectives including an evaluation of Diabetes self-management skills (using the Summary of Diabetes Self-Care Activities Measure), self-efficacy (measured through a five point Likert scale survey), and treatment satisfaction (assessed via the Diabetes Treatment Satisfaction Questionnaire Change tool)."

Answered by AI

How many participants is the research team recruiting for this experiment?

"Affirmative. According to the data available from clinicaltrials.gov, this medical study still has open recruitment slots for 70 patients at a single location. Initially posted on January 13th 2021 and last updated September 13th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Development and Feasibility Testing of DM-BOOST Intervention.

Daniel Amante 2021. "Development and Feasibility Testing of DM-BOOST Intervention.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04710940.