DM-BOOST Para Latinx: a Diabetes Mellitus Program Using Behavioral Economics to Optimize Outreach and Self-management Support With Technology for Latinx Patients

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

DM-BOOST Para Latinx: a Diabetes Mellitus Program Using Behavioral Economics to Optimize Outreach and Self-management Support With Technology for Latinx Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05583877
• Other study ID #: STUDY00000376
• Secondary ID: 1K01DK131318
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: June 2024
• Source: University of Massachusetts, Worcester
• Contact: Daniel J Amante, PhD, MPH
• Phone: 508-856-8480
• Email: daniel.amante[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The specific aims of this project are to culturally adapt the DM-BOOST intervention for Latinx patients, usability test 'DM-BOOST para Latinx' to optimize cultural appropriateness and patient engagement and conduct a feasibility evaluation of DM-BOOST para Latinx. These aims will be accomplished via a community-based participatory research approach in collaboration with clinical, community and patient partners. This project will inform subsequent proposals to evaluate implementation of DM-BOOST in the UMass Memorial Health Care system.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: May 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Aims 1 and 2 Patient Inclusion Criteria:

• Age > 18 years

• Diagnosis of type 2 diabetes

• Identifies as Hispanic/Latinx

• Spanish language preference

Aims 1 and 2 Patient Exclusion Criteria:

• Cognitive impairment

• Current prisoner

• Pregnant women

Aim 3 Patient Inclusion Criteria:

• Age > 18 years

• Diagnosis of type 2 diabetes

• Identifies as Hispanic/Latinx

• Spanish language preference

Aim 3 Patient Exclusion Criteria:

• Cognitive impairment

• Current prisoner

• Pregnant women

• Completed DSMT in previous year

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Diabetes BOOST
Participants will receive supportive care using technology for DSMT in addition to usual care.
• Usual Care
Participants will receive usual care for DSMT.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Daniel Amante	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Process Evaluation	Evaluate engagement by examining the number of DSMT appointments scheduled, cancellation/no show rates and total number of DSMT-related encounters completed.	3 - 6 months
Secondary	Diabetes self-efficacy	Diabetes self efficacy will be measured at baseline and 3 months after enrolling in the study using the Diabetes Management Self-Efficacy Scale. Participants will provide feedback on set of questions, using a 5-point Likert scale( with 1=Strong Disagree, 2=Somewhat Disagree, 3= Neutral, 4=Somewhat Agree, 5= Strongly Agree)	3 months
Secondary	Diabetes treatment satisfaction	Diabetes Treatment Satisfaction will be measured at 3 months after enrolling in the study using the Diabetes Treatment Satisfaction Questionnaire Change tool. Participants will be asked to share how their experience of current treatment has changed from their experience of treatment before the study began. They will answer each question by choosing 3 for Much More Satisfied Now up to -3 for Much Less Satisfied Now. (3,2,1,0,-1,-2,-3)	3 months
Secondary	Diabetes self-management skills	Self-management skills will be measured at 3 months after enrolling in the study. Participants will complete the Summary of Diabetes Self-Care Activities (SDSCA) measure. The SDSCA measures frequency of performing diabetes self-care activities over the last seven days including diet, exercise, blood glucose testing, foot care and tobacco use. The respondent marks the number of days on which the indicated behavior was performed on an eight-point Likert scale to answer the questions. The first ten items are summed to a total score as well as to four sub scores: diet (item 1-4), exercise (item 5-6), blood-glucose testing (item 7-8) and foot-care (item 9-10). For the first ten items, a higher score indicates greater self-care activities. The eleventh item focuses on smoking habits and assesses the average number of cigarettes smoked per day. A higher score on the eleventh item indicates worse self-care.	3 months
Secondary	Change in HbA1c Percentage	Measurement of HbA1c values to determine impact of intervention. HbA1c values at baseline visit will be compared with values at 3-6 months after participant's enrollment. These data will be obtained through EHR chart review.	6 months