[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07091487":3,"trial-entities:NCT07091487":124,"trial-summary:NCT07091487":128},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":41,"secondary_outcomes":46,"sex":90,"minimum_age":91,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":92,"std_ages":96,"locations":99,"central_contacts":117,"overall_officials":120,"references":122,"see_also_links":123},"NCT07091487","IRB-FY2024-849","Effectiveness of the Diabetes Homeless Medication Support (D-HOMES) Program on Diabetes Management","RECRUITING","2029-09-30","2025-07","2025-07-29","2025-06-25","Katherine Vickery","OTHER",false,"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:\n\n* Do D-HOMES participants have greater reductions in HbA1c at 3 months than participants who received education?\n* Do D-HOMES participants have greater reductions in HbA1c at 6 and 12 months compared to those who received education?\n* 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?\n* What factors must be considered to make D-HOMES scalable?\n\nParticipants will:\n\n* complete 5 assessments including two baseline assessments and follow-ups at months 3,6, and 12\n* participate in a one-time education session or 10 weeks of wellness coaching.",null,[18],"Type 2 Diabetes",[18,20,21],"Homelessness","Behavioral Activation","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},256,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","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 coach will also provide a tailored tool matched to the patient's needs\u002Fgoals and tailored diabetes education as needed.",[35],"Diabetes Homeless Medication Support (D-HOMES)",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Enhanced Usual Care\u002F 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 adherence (e.g. pillbox).",[40],"Enhanced Usual Care\u002FEducation Session",[42],{"measure":43,"description":44,"timeFrame":45},"Change in HbA1c at 3 months","Measure effectiveness of D-HOMES (10 BA coach sessions over 3 mos.) vs. enhanced usual care (\\[EUC\\], a single brief diabetes educational session and referrals) on glycemic control, measured by HbA1c, among people who have recently experienced homelessness","From Baseline 1 to Month 3 assessment",[47,51,55,59,62,65,67,71,74,77,79,83,85,88],{"measure":48,"description":49,"timeFrame":50},"HbA1c at 6 months","Effectiveness of D-HOMES (10 BA coach sessions over 3 mos.) vs. enhanced usual care (\\[EUC\\], a single brief diabetes educational session and referrals) on glycemic control, measured by HbA1c, at 6 months","Baseline 1 to 6-month assessment",{"measure":52,"description":53,"timeFrame":54},"HbA1c at 12 months","Effectiveness of D-HOMES (10 BA coach sessions over 3 mos.) vs. enhanced usual care (\\[EUC\\], a single brief diabetes educational session and referrals) on glycemic control, measured by HbA1c, at 12 months","Baseline 1 to 12-month assessment",{"measure":56,"description":57,"timeFrame":58},"Diabetes self-care and medication adherence (DSMQ) - 3 months","The Diabetes Self-Management Questionnaire (DSMQ) is a brief, comprehensive 16-item self-report instrument designed to assess four subscales -Glucose Management, Dietary Control, Physical Activity, and Health-Care Use - as well as a global measure called the Sum Scale. This tool uses a likert scale of 0-3.","Baseline 2 to 3-month assessment",{"measure":60,"description":57,"timeFrame":61},"Diabetes self-care and medication adherence (DSMQ) - 6 months","Baseline 2 to 6-month assessment",{"measure":63,"description":64,"timeFrame":58},"Difficulties with diabetes management (PAID-5) at 3 months","The PAID-5 is a short, five-item questionnaire used to assess diabetes-related emotional distress. Each item is scored on a scale of 0 to 4. The total score ranges from 0 to 20, with scores of 8 or above indicating diabetes-related distress.",{"measure":66,"description":64,"timeFrame":61},"Difficulties with diabetes management (PAID-5) at 6 months",{"measure":68,"description":69,"timeFrame":70},"MHI-5 at 3 months","The Mental Health Inventory - Five Item (MHI-5) includes 5 questions about mental health over the past month. Responses are on a likert scale ranging from 1 = all the time to 6 = none of the time. Raw scores range from a minimum of 5 to a maximum of 30, where higher scores indicate better mental health.","Baseline 2 through 3-month assessment",{"measure":72,"description":69,"timeFrame":73},"MHI-5 at 6 months","Baseline 2 through 6-month assessment",{"measure":75,"description":76,"timeFrame":58},"Euro-QoL-5 at 3 months","The EuroQuol-5D-5L has 6 questions. 5 of these questions address mobility, self care, usual activities, pain\u002Fdiscomfort, and anxiety\u002Fdepression. These 5 questions are answered on a likert scale of 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, 5=unable to\u002Fextreme problems. The 6th question is a 0-100 scale of overall health. Data is presented as a health state or a 5-digit code representing the 1-5 responses of the 5 questions.",{"measure":78,"description":76,"timeFrame":61},"Euro-QoL-5 at 6 months",{"measure":80,"description":81,"timeFrame":82},"Blood Pressure at 3 months","Recorded in systolic\u002Fdiastolic mmHg","Baseline 1 to 3-month assessment",{"measure":84,"description":81,"timeFrame":50},"Blood Pressure at 6 months",{"measure":86,"description":87,"timeFrame":82},"Body Mass Index (BMI) at 3 months","Measured as BMI = weight (kg) \u002F height (m)\\^2",{"measure":89,"description":87,"timeFrame":50},"Body Mass Index (BMI) at 6 months","ALL","18 Years",{"inclusion":93,"exclusion":94,"raw_text":95},[],[],"Inclusion Criteria:\n\n1. Age 18 yrs. or older\n2. English or Spanish-speaking\n3. Recent homelessness by HUD and HHS definitions\n\n   1. Any housing instability in the last 12 mo. (includes supported housing or worry about paying rent)\n   2. Significant housing instability in the last 24 mos. (includes any stay in shelter, outside, or places not meant for human habitation)\n4. Self-reported diagnosis of type 2 diabetes with A1c \\>7.5%, later verified in medical record and study lab. test\n5. Plan to stay in local area or be reachable by phone for the next 12 months\n6. Willingness to work on medication adherence and diabetes self-care\n\nExclusion Criteria:\n\n1. Inability to provide informed consent (e.g., presence of a legal guardian, prisoners)\n2. Active psychosis or intoxication precluding ability to give informed consent\n3. Pregnant or lactating people at initial enrollment, determined by specific screening questions.",[97,98],"ADULT","OLDER_ADULT",[100],{"facility":101,"status":7,"city":102,"state":103,"zip":104,"country":105,"contacts":106,"geoPoint":114},"Hennepin Healthcare Research Institute","Minneapolis","Minnesota","55404","United States",[107,112],{"name":108,"role":109,"phone":110,"email":111},"Katherine D Vickery, MD, MSc","CONTACT","612-873-6852","katherine.vickery@hcmed.org",{"name":108,"role":113},"PRINCIPAL_INVESTIGATOR",{"lat":115,"lon":116},44.97997,-93.26384,[118],{"name":108,"role":109,"phone":119,"email":111},"6128736852",[121],{"name":108,"affiliation":101,"role":113},[],[],{"nct_id":4,"conditions":125,"biomarkers":127},[126],"Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":129,"summary":130,"prompt_version":140},true,{"design":131,"status":132,"heading":133,"summary":134,"follow_up":135,"word_count":136,"commitments":137,"compensation":138,"drugs_mentioned":139},"This interventional study plans to enroll 256 participants. It compares two behavioral interventions: the D-HOMES program (10 sessions) and Enhanced Usual Care\u002FEducation (1 session).","completed","D-HOMES Program for Type 2 Diabetes and Homelessness","This study is testing the \"Diabetes Homeless Medication Support (D-HOMES) Program\" to see if it helps adults with Type 2 diabetes who have recently experienced homelessness. You could be eligible if you are 18 or older, speak English or Spanish, and have a specific blood sugar level (HbA1c at or above 7.5). Researchers want to see if 10 one-on-one coaching sessions improve blood sugar control more than a single education session. The main goal is to see if participants in the D-HOMES program have better reductions in their HbA1c (a measure of average blood sugar over 2-3 months) after 3 months. The study aims to enroll 256 participants, but its current recruitment status is unclear.","Your HbA1c will be measured at 3, 6, and 12 months after starting the study to see the long-term effects.",115,"If you participate, you would either receive 10 one-on-one coaching sessions (30 minutes each over 12 weeks) or one 15-minute education session about diabetes.","Not stated in the trial record.",[32],"v2"]