Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) Program on Diabetes Management

Обзор

The goal of this clinical trial is to learn if the Diabetes Homelessness Medication Support (D-HOMES) wellness coaching model is effective for adults who speak English or Spanish, have Type 2 diabetes with an HbA1c at or above 7.5, and have recently experienced homelessness. Researchers will compare a one-time education session about diabetes to 10 wellness coaching sessions to see if there are differences between the groups' health outcomes. The main questions it aims to answer are: * Do D-HOMES participants have greater reductions in HbA1c at 3 months than participants who received education? * Do D-HOMES participants have greater reductions in HbA1c at 6 and 12 months compared to those who received education? * Do D-HOMES participants have improvements in blood pressure control, quality of life, self-reported psychological wellness, diabetes distress, and diabetes medication adherence and self-management at 3, 6, and 12 months? * What factors must be considered to make D-HOMES scalable? Participants will: * complete 5 assessments including two baseline assessments and follow-ups at months 3,6, and 12 * participate in a one-time education session or 10 weeks of wellness coaching.

Вмешательства

• Поведенческое Diabetes Homeless Medication Support
  There will be 10 one-on-one sessions offered within 12 weeks to participants. Sessions will last approximately 30 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors and psychologiccal wellness to the extent that participants are willing. The coach will also help with resource and care coordination. The
• Поведенческое Enhanced Usual Care/ Education
  Trained diabetes wellness coaches will provide approximately 15 minutes of instruction about the basic concepts of diabetes. They will use handouts aligned with American Diabetes Association guidelines. They will use the ask-offer-ask method to review these with participants and answer basic questions. Handouts will cover (1) general diabetes knowledge, (2) healthy eating with diabetes, (3) physical activity with diabetes. The coach will also provide a general tool to support medication adherenc

Первичные конечные точки

• Change in HbA1c at 3 months [Срок оценки: From Baseline 1 to Month 3 assessment]

Вторичные конечные точки (12)

• HbA1c at 6 months [Срок оценки: Baseline 1 to 6-month assessment]
• HbA1c at 12 months [Срок оценки: Baseline 1 to 12-month assessment]
• Diabetes self-care and medication adherence (DSMQ) - 3 months [Срок оценки: Baseline 2 to 3-month assessment]
• Diabetes self-care and medication adherence (DSMQ) - 6 months [Срок оценки: Baseline 2 to 6-month assessment]
• Difficulties with diabetes management (PAID-5) at 3 months [Срок оценки: Baseline 2 to 3-month assessment]
• Difficulties with diabetes management (PAID-5) at 6 months [Срок оценки: Baseline 2 to 6-month assessment]
• MHI-5 at 3 months [Срок оценки: Baseline 2 through 3-month assessment]
• MHI-5 at 6 months [Срок оценки: Baseline 2 through 6-month assessment]
• Euro-QoL-5 at 3 months [Срок оценки: Baseline 2 to 3-month assessment]
• Euro-QoL-5 at 6 months [Срок оценки: Baseline 2 to 6-month assessment]
• Blood Pressure at 3 months [Срок оценки: Baseline 1 to 3-month assessment]
• Blood Pressure at 6 months [Срок оценки: Baseline 1 to 6-month assessment]

Критерии участия

Критерии включения

• Age 18 yrs. or older
• English or Spanish-speaking
• Recent homelessness by HUD and HHS definitions

• 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 with A1c >7.5%, later verified in medical record and study lab. test
• Plan to stay in local area or be reachable by phone for the next 12 months
• Willingness to work on medication adherence and diabetes self-care

Критерии исключения

• 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 people at initial enrollment, determined by specific screening questions.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Hennepin Healthcare Research Institute — Minneapolis

Идентификаторы

NCT: NCT07091487 · IRB-FY2024-849 · R01DK139152

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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