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Joint Patient and Caregiver Intervention for Older African Americans With Type 2 Diabetes

Joint Patient and Caregiver Intervention for Older African Americans With Poorly Controlled Type 2 Diabetes (Joint Home-DM-BAT)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 120 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a phone-based program for Black/African American adults age 50 or older with poorly controlled type 2 diabetes and their family or friend caregivers. The program teaches diabetes care, helps solve problems with social needs, and helps people take part in activities. It will compare the program with usual care to see how it affects patient health, quality of life, and caregiver stress.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Patients must be age 50 or older.
  • Patients must identify as Black/African American.
  • Patients must have diagnosed type 2 diabetes and an A1c of 8% or higher at screening. A1c measures average blood sugar.
  • Patients must be able to communicate in English.
  • Patients must have a family member or close friend willing to join the study for 6 months.
  • Caregivers must attend four 1-hour sessions with the patient.
  • Caregivers must support the patient during the 6-month study.
  • Caregivers must complete short assessments at the start, at 3 months, and at 6 months.

Who can't join

  • Patients or caregivers with confusion at screening that suggests serious dementia, a condition that affects memory and thinking.
  • Patients or caregivers with alcohol or drug abuse or dependence at screening.
  • Patients or caregivers with active psychosis, which means trouble knowing what is real, or an acute mental health disorder at screening.
  • Patients or caregivers expected to live less than 6 months at screening.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (1)

WI