Back to resultsDM-BOOST Para Latinx: a Diabetes Mellitus Program Using Behavioral Economics to Optimize Outreach and Self-management Support With Technology for Latinx Patients
Primary Purpose
Diabetes Mellitus, Type 2
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes BOOST
Usual Care
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2
Eligibility 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
Sites / Locations
- University of Massachusetts Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention - Diabetes BOOST
Usual Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Process Evaluation
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
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)
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)
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.
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.
Full Information
NCT ID
NCT05583877
First Posted
October 13, 2022
Last Updated
May 3, 2023
Sponsor
Daniel Amante
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT05583877
Brief Title
DM-BOOST Para Latinx: a Diabetes Mellitus Program Using Behavioral Economics to Optimize Outreach and Self-management Support With Technology for Latinx Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Amante
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention - Diabetes BOOST
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes BOOST
Intervention Description
Participants will receive supportive care using technology for DSMT in addition to usual care.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Participants will receive usual care for DSMT.
Primary Outcome Measure Information:
Title
Process Evaluation
Description
Evaluate engagement by examining the number of DSMT appointments scheduled, cancellation/no show rates and total number of DSMT-related encounters completed.
Time Frame
3 - 6 months
Secondary Outcome Measure Information:
Title
Diabetes self-efficacy
Description
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)
Time Frame
3 months
Title
Diabetes treatment satisfaction
Description
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)
Time Frame
3 months
Title
Diabetes self-management skills
Description
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.
Time Frame
3 months
Title
Change in HbA1c Percentage
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel J Amante, PhD, MPH
Phone
508-856-8480
Email
daniel.amante@umassmed.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Geraldine Puerto, MPH
Phone
508-856-8976
Email
geraldine.puerto@umassmed.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Amante, PhD, MPH
Organizational Affiliation
UMass Chan Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Amante, PhD, MPH
Phone
774-418-3645
Email
Daniel.Amante@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Geraldine Puerto, MPH
Phone
508-856-8976
Email
Geraldine.Puerto@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Daniel Amante, PhD, MPH
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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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