[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06279637":3,"trial-entities:NCT06279637":76,"trial-summary:NCT06279637":80},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":38,"secondary_outcomes":43,"sex":44,"minimum_age":45,"maximum_age":46,"healthy_volunteers":47,"eligibility_criteria":48,"std_ages":52,"locations":55,"central_contacts":68,"overall_officials":73,"references":74,"see_also_links":75},"NCT06279637","PRO00046457","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)","RECRUITING","2026-07-31","2025-07","2025-07-29","2024-03-04","Medical College of Wisconsin","OTHER",true,"This study will test the preliminary efficacy of a joint patient\u002Finformal 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\u002Fcaregiver dyads to the Joint Home intervention (n=50) and usual care (n=50) arms.\n\nThe aims of the study are:\n\nAim 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).\n\nAim 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.\n\nAim 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.",null,[19],"Type 2 Diabetes",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[24],"NA",{"count":26,"type":27},100,"ESTIMATED",[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Joint Home-DM-BAT Intervention","8 weekly sessions of telephone-delivered, manualized education on diabetes management, problem solving of social needs, and behavioral activation.",[31],{"type":30,"name":35,"description":36,"armGroupLabels":37},"Usual Care","Diabetes education materials will be mailed weekly and monthly according to the booster schedule",[35],[39],{"measure":40,"description":41,"timeFrame":42},"Glycemic Control (Hemoglobin A1C [HbA1C])","About 10cc of blood will be drawn by trained phlebotomists and sent to the lab for testing.","Change in baseline HbA1C at 6 months post intervention follow-up",[],"ALL","50 Years","120 Years",false,{"inclusion":49,"exclusion":50,"raw_text":51},[],[],"Patient Inclusion Criteria:\n\n1. Age ≥50 years of age;\n2. Self-identified as Black\u002FAfrican American;\n3. Clinical diagnosis of T2DM and poorly controlled, defined as HbA1c ≥8% at the screening visit;\n4. Able to communicate in English; and\n5. Has an informal caregiver (family member or close friend willing to participate in the study for 6 months.\n\nCaregiver Inclusion Criteria:\n\n1. Willing to attend 4, one-hour sessions with the study participant;\n2. Willing to support the study participant for study duration (6 months); and\n3. Willing to complete brief baseline, 3- and 6-month assessments.\n\nPatient\u002FCaregiver Exclusion Criteria:\n\n1. Mental confusion at screening assessment suggesting significant dementia;\n2. Alcohol or drug abuse\u002Fdependency at screening assessment;\n3. Active psychosis or acute mental disorder at screening assessment; and\n4. Life expectancy \\\u003C6 months at screening.",[53,54],"ADULT","OLDER_ADULT",[56],{"facility":13,"status":8,"city":57,"state":58,"zip":59,"country":60,"contacts":61,"geoPoint":65},"Milwaukee","Wisconsin","53226","United States",[62],{"name":63,"role":64},"Aprill Dawson","CONTACT",{"lat":66,"lon":67},43.0389,-87.90647,[69],{"name":70,"role":64,"phone":71,"email":72},"Aprill Z Dawson, PhD, MPH","414-955-8828","adawson@mcw.edu",[],[],[],{"nct_id":4,"conditions":77,"biomarkers":79},[78],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":15,"summary":81,"prompt_version":91},{"design":82,"status":83,"heading":84,"summary":85,"follow_up":86,"word_count":87,"commitments":88,"compensation":89,"drugs_mentioned":90},"This is an interventional study that will randomly assign 100 patient and caregiver pairs to either the Joint Home-DM-BAT intervention or usual care.","completed","Joint Intervention for Older African Americans with Type 2 Diabetes","This study is testing a program called Joint Home-DM-BAT for older African Americans with poorly controlled type 2 diabetes. This program involves 8 weekly phone sessions that teach about diabetes management, problem-solving for social needs, and ways to become more active. It's compared to usual care, which involves receiving diabetes education materials by mail. The study aims to see if Joint Home-DM-BAT can improve blood sugar control (measured by Hemoglobin A1C [HbA1C]), blood pressure, and cholesterol, as well as quality of life. You may be able to join if you are an African American aged 50-120 with type 2 diabetes and an HbA1c of 8% or higher, and have a family member or close friend willing to participate with you. The study plans to enroll 100 patient-caregiver pairs.","Blood sugar control (HbA1C) will be measured at 6 months after the intervention ends.",128,"Participants in the Joint Home-DM-BAT group will have 8 weekly telephone sessions. Diabetes education materials will be mailed weekly and monthly to the usual care group.","Not stated in the trial record.",[35],"v2"]