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

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ClinicalTrials.gov Identifier: NCT05583877
Recruitment Status : Not yet recruiting
First Posted : October 18, 2022
Last Update Posted : May 6, 2023
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Daniel Amante, University of Massachusetts, Worcester

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: Diabetes BOOST Behavioral: Usual Care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The purpose of this study is to culturally-adapt a patient-centric intervention designed to improve implementation of diabetes self-management training in Spanish-speaking patients. To accomplish cultural adaptation of the DM-BOOST intervention, a Patient Research Expert Panel (PREP) (n</=4) will participate in Community Engagement Studios to inform adaptations (Aim 1) and usability test the intervention (Aim 2). A randomized pilot with new patients (n</=70) will then be conducted to assess feasibility (Aim 3).
Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Supportive Care
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
Estimated Study Start Date : January 1, 2024
Estimated Primary Completion Date : February 1, 2025
Estimated Study Completion Date : May 1, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention - Diabetes BOOST
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 to review the functionality of their patient portal and refine diabetes-related goals. 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
Participants will receive supportive care using technology for DSMT in addition to usual care.
Active Comparator: Usual Care
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
Participants will receive usual care for DSMT.


Outcome Measures
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Primary Outcome Measures :
  1. Process Evaluation [ Time Frame: 3 - 6 months ]
    Evaluate engagement by examining the number of DSMT appointments scheduled, cancellation/no show rates and total number of DSMT-related encounters completed.


Secondary Outcome Measures :
  1. Diabetes self-efficacy [ Time Frame: 3 months ]
    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)

  2. Diabetes treatment satisfaction [ Time Frame: 3 months ]
    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. Diabetes self-management skills [ Time Frame: 3 months ]
    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.

  4. Change in HbA1c Percentage [ Time Frame: 6 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05583877


Contacts
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Contact: Daniel J Amante, PhD, MPH 508-856-8480 daniel.amante@umassmed.edu
Contact: Geraldine Puerto, MPH 508-856-8976 geraldine.puerto@umassmed.edu

Locations
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United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Contact: Daniel Amante, PhD, MPH    774-418-3645    Daniel.Amante@umassmed.edu   
Contact: Geraldine Puerto, MPH    508-856-8976    Geraldine.Puerto@umassmed.edu   
Principal Investigator: Daniel Amante, PhD, MPH         
Sponsors and Collaborators
Daniel Amante
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Daniel J Amante, PhD, MPH UMass Chan Medical School
More Information
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Responsible Party: Daniel Amante, Assistant Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT05583877    
Other Study ID Numbers: STUDY00000376
1K01DK131318 ( U.S. NIH Grant/Contract )
First Posted: October 18, 2022    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases