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临床试验/NCT05583877
NCT05583877已完成不适用

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

Daniel Amante4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
4
主要终点
Process Evaluation

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Intervention - Diabetes BOOST

Experimental

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.

干预措施: Diabetes BOOST (Behavioral)

Usual Care

Active Comparator

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.

干预措施: Usual Care (Behavioral)

结局指标

主要结局

Process Evaluation

时间窗: 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.

次要结局

  • Diabetes self-efficacy(3 months)
  • Diabetes treatment satisfaction(3 months)
  • Change in HbA1c Percentage(6 months)

研究者

发起方
Daniel Amante
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniel Amante

Assistant Professor

University of Massachusetts, Worcester

研究点 (4)

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