跳至主要内容
临床试验/NCT05819749
NCT05819749已完成不适用

Expanding the Diabetes Homelessness Medication Support (D-Homes) Program to Spanish Speaking Hispanics

Hennepin Healthcare Research Institute2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Acceptability of Intervention

研究概览

简要总结

This single-arm trial of the Diabetes Homeless Medication Support intervention for Spanish-speaking people (n=12) will test the perception and feasibility of anticipated study procedures.

详细描述

This study has an overall goal to modify and pilot test a previously developed collaborative care intervention using motivational interviewing and behavioral activation alongside education and psychosocial support to improve medication adherence tailored to the experiences of people experiencing homelessness and diabetes (DH). The intervention was developed in English. This study is intended to test the modified intervention for DH who speak Spanish (DH-SH). The study team's central hypothesis is that medication adherence and diabetes self-care (and eventual glycemic control, health care use/cost) will improve with an intervention tailored to the unique context of DH-SH.

This protocol tests patient perceptions of the feasibility and acceptability of study procedures and refines the D-Homes treatment manual through test cases (n=12). The study team hypothesizes that the D-Homes manual and study procedures will be feasible and acceptable to DH-SH as measured by self-report and post-treatment interview.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • Age 18 yrs or older
  • Spanish-speaking
  • Recent homelessness by federal definition (HEARTH ACT)
  • Any housing instability in the last 12 mo. (includes supported housing or worry about paying rent)
  • Significant housing instability in the last 24 mos. (includes any stay in shelter, outside, or places not meant for human habitation)
  • Self-reported diagnosis of type 2 diabetes, later verified in medical record
  • Plan to stay in local area or be reachable by phone for the next 16 weeks
  • Willingness to work on medication adherence and diabetes self-care

排除标准

  • Inability to provide informed consent (e.g. presence of a legal guardian, prisoners)
  • Active psychosis or intoxication precluding ability to give informed consent
  • Pregnant or lactating females
  • Patients who choose to opt out of research

结局指标

主要结局

Acceptability of Intervention

时间窗: at 16 weeks

Client Satisfaction Questionnaire, 8-item version, with a score range from 8-32, higher score indicating higher satisfaction.

次要结局

  • Change in Glycemic Control(Baseline and 16 weeks)
  • Health-related Quality of Life(Baseline and 16 weeks)
  • Diabetes Medication Adherence(Baseline and 16 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验