Diabetes Homeless Medication Support Single Arm Treatment Development Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 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 alone (n=15) will test the perception and feasibility of anticipated study procedures.
详细描述
This study is of a set of studies with an overall goal to develop and pilot test a 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). Our 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.
This protocol addresses a pilot study to test patient perceptions of the feasibility and acceptability of study procedures and refine the D-Homes treatment manual through test cases (n=15). With a hypothesis that the D-Homes manual and study procedures will be feasible and acceptable to DH 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
- 否
入选标准
- •Age 18 yrs. or older
- •English-speaking
- •Homelessness by federal definition in the last 12 mo.
- •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
- •HbA1c >/= 7.5%
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
- Diabetes Medication Adherence(Baseline to 12 weeks)
- Hemoglobin A1c(Baseline to 16 weeks)
- Psychological Wellness(Baseline to 16 weeks)