Diabetes Mellitus, Type 2
Conditions
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.
Interventions
BEHAVIORALDiabetes BOOST
Participants will receive supportive care using technology for DSMT in addition to usual care.
BEHAVIORALUsual Care
Participants will receive usual care for DSMT.
Sponsors
Daniel Amante
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, 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.
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Process Evaluation | 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
| Measure | Time frame | Description |
|---|---|---|
| Diabetes self-efficacy | 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) |
| Diabetes treatment satisfaction | 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) |
| Change in HbA1c Percentage | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel J Amante, PhD, MPH
UMass Chan Medical School
Outcome results
None listed