Caregiver Support for Poorly Controlled Type 2 Diabetes
Joint Patient and Caregiver Intervention for Older African Americans With Type 2 Diabetes
Recruiting
N/AInterventional Study
Type 2 Diabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
50 – 120
Sex
Any
Study type
Interventional
Purpose
Health Services Research
Participants needed
100 (estimated)
Sponsor
Medical College of Wisconsin · Other
Who this trial is looking for
This trial is looking for older African Americans with poorly controlled type 2 diabetes and their informal caregivers. Participants will receive support through phone sessions focused on diabetes education and community needs over six months.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 50 years old.
I identify as Black or African American.
I have been diagnosed with type 2 diabetes and my blood sugar is not well controlled.
I can communicate in English.
I have a family member or close friend willing to support me in the study.
You may not be able to join if
I have significant mental confusion or dementia.
I have a history of alcohol or drug abuse.
I am currently experiencing psychosis or an acute mental disorder.
I have a life expectancy of less than 6 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
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This study will test the preliminary efficacy of a joint patient/informal caregiver telephone-delivered intervention that includes diabetes education; problem solving around social needs; and behavioral activation for older African Americans with poorly controlled type 2 diabetes by randomizing 100 patient/caregiver dyads to the Joint Home intervention (n=50) and usual care (n=50) arms.
The aims …
This study will test the preliminary efficacy of a joint patient/informal caregiver telephone-delivered intervention that includes diabetes education; problem solving around social needs; and behavioral activation for older African Americans with poorly controlled type 2 diabetes by randomizing 100 patient/caregiver dyads to the Joint Home intervention (n=50) and usual care (n=50) arms.
The aims of the study are:
Aim 1: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on patient clinical outcomes (hemoglobin A1c, blood pressure, and LDL-Cholesterol).
Aim 2: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) Joint Home DM-BAT on patient quality of life.
Aim 3: To test the preliminary efficacy of home-based, joint patient and caregiver intervention (Joint Home-DM-BAT) on caregiver quality of life and caregiver burden.
Trial Locations
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Eligibility Criteria
Patient Inclusion Criteria:
1. Age ≥50 years of age;
2. Self-identified as Black/African American;
3. Clinical diagnosis of T2DM and poorly controlled, defined as HbA1c ≥8% at the screening visit;
4. Able to communicate in English; and
5. Has an informal caregiver (family member or close friend wil…
Patient Inclusion Criteria:
1. Age ≥50 years of age;
2. Self-identified as Black/African American;
3. Clinical diagnosis of T2DM and poorly controlled, defined as HbA1c ≥8% at the screening visit;
4. Able to communicate in English; and
5. Has an informal caregiver (family member or close friend willing to participate in the study for 6 months.
Caregiver Inclusion Criteria:
1. Willing to attend 4, one-hour sessions with the study participant;
2. Willing to support the study participant for study duration (6 months); and
3. Willing to complete brief baseline, 3- and 6-month assessments.
Patient/Caregiver Exclusion Criteria:
1. Mental confusion at screening assessment suggesting significant dementia;
2. Alcohol or drug abuse/dependency at screening assessment;
3. Active psychosis or acute mental disorder at screening assessment; and
4. Life expectancy \<6 months at screening.
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