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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Diabetes BOOST
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention - Diabetes BOOST<br>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<br>* Participants will receive supportive care using technology for DSMT in addition to usual care.<br>|
| Active Comparator: Usual Care<br>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<br>* Participants will receive usual care for DSMT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |