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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 13, 2022
First Posted Date  ICMJE October 18, 2022
Last Update Posted Date May 6, 2023
Estimated Study Start Date  ICMJE January 1, 2024
Estimated Primary Completion Date February 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2022)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2022)
  • 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)
  • 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)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2022)
  • 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)
  • 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)
  • Diabetes self-management skills [ Time Frame: 3 months ]
    Self-management skills will be measured at 3 months after enrolling in the study. Participant will be asked questions about their diabetes self-care activities during the past seven days using the Summary of Diabetes Self-Care Activities Measure.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE DM-BOOST Para Latinx: a Diabetes Mellitus Program Using Behavioral Economics to Optimize Outreach and Self-management Support With Technology for Latinx Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Behavioral: Diabetes BOOST
    Participants will receive supportive care using technology for DSMT in addition to usual care.
  • Behavioral: Usual Care
    Participants will receive usual care for DSMT.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Diabetes BOOST
  • 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.
    Intervention: Behavioral: Usual Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 13, 2022)		 70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2025
Estimated Primary Completion Date February 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Daniel J Amante, PhD, MPH 508-856-8480 daniel.amante@umassmed.edu
Contact: Geraldine Puerto, MPH 508-856-8976 geraldine.puerto@umassmed.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05583877
Other Study ID Numbers  ICMJE STUDY00000376
1K01DK131318 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Daniel Amante, University of Massachusetts, Worcester
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Daniel Amante
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Daniel J Amante, PhD, MPH UMass Chan Medical School
PRS Account University of Massachusetts, Worcester
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP