A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Change from baseline HbA1c
研究概览
简要总结
To improve diabetes self-management outcomes, patients with type 2 diabetes (n=150 - aged 13-84) recruited from St. Vincent Clinic (SVC) and Teen Health Center Inc., Clinics will be randomized using block randomization to receive standard of care or the integrated model. Patients in the intervention arm will be assessed for social and physical needs before being enrolled in a year-long education program (iDSMES). Enrollees will receive dietary counseling, physical and occupational therapy, in addition to other mental, financial and social benefits counseling. The investigators will compare the intervention outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 84 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 13-84, and
- •Patients diagnosed with type 2 diabetes, and
- •Patients have a BMI equal to or >25 (23, if Asians), and
- •Hemoglobin A1c value equal to or >7%
排除标准
- •Ages <13 or >84
- •Pregnancy. If a subject becomes pregnant, they will advised to discontinue the study.
- •Previous diagnosis of type 1 diabetes
- •Inability to participate for 12-month duration (e.g., Disorders that might compromise survival, planning to relocate outside the geographical coverage of University of Texas Medical Branch (UTMB) clinics
- •Other medical condition or medication administration deemed exclusionary by the study investigators
研究组 & 干预措施
iDSMES
Eligible study subjects randomized to the intervention arm will receive:
A. Intensive Diabetes Self-Management, Education, and Support (iDSMES). Participants will be enrolled in groups in a virtual or in-person setting with their lifestyle coach, in this one-year educational program B. Services addressing Social Determinants of Health All study subjects will have their data collected at time points around baseline, 6 months and 12 months from consenting including glycemic control, hypertension management, dyslipidemia management, prevention or management of complications, healthcare outcomes, lifestyle change outcomes, patient-centeredness outcomes, Secondary diabetes self-management behaviors, self-efficacy in managing diabetes, diabetes distress, and Morisky Green Levine Medication Adherence Scale.
干预措施: iDSMES (Other)
Standard of Care
Eligible study subjects randomized to the intervention arm will receive standard of care offered to patients with diabetes.
干预措施: Standard of Care (Other)
结局指标
主要结局
Change from baseline HbA1c
时间窗: at 12 months
measurement of hemoglobin A1c (HbA1c %)
Change from baseline HbA1c
时间窗: at 6 months
measurement of hemoglobin A1c (HbA1c %)
次要结局
- Change from baseline blood pressure(at 12 months)
- Change from baseline weight(at 12 months)
- Change from baseline lipid profile(at 12 months)
- Change from baseline frequency of provider encounter(at 12 months)
- Change from baseline frequency of feet examination for neuropathy(at 12 months)
- Change from baseline frequency of urine exam for microalbuminuria(at 12 months)
- Change from baseline frequency of oral health checkup(at 12 months)
- Change from baseline frequency of eye fundus examination(at 12 months)
- Change from baseline patient-centeredness(at 12 months)
- Change from baseline frequency of emergency care visits for treatment of T2-related issues(at 12 months)
- Change from baseline frequency of hospitalizations and re-admissions(at 12 months)
- Participation in iDSMES classes (for those in the intervention arm only)(at 12 months)
- Lifestyle change outcomes (for those in the intervention arm only)(every session through study completion, an average of 1 year)
- Change from baseline secondary diabetes self-management behaviors(at 12 months)
- Change from baseline self-efficacy in managing diabetes(at 12 months)
- Change from baseline diabetes distress(at 12 months)
- Change from baseline medication Adherence(at 12 months)
- Change from baseline weight(at 6 months)
- Change from baseline blood pressure(at 6 months)
- Change from baseline lipid profile(at 6 months)
- Change from baseline frequency of provider encounter(at 6 months)
- Change from baseline frequency of feet examination for neuropathy(at 6 months)
- Change from baseline frequency of urine exam for microalbuminuria(at 6 months)
- Change from baseline frequency of oral health checkup(at 6 months)
- Change from baseline frequency of eye fundus examination(at 6 months)
- Change from baseline frequency of emergency care visits for treatment of T2-related issues(at 6 months)
- Change from baseline frequency of hospitalizations and re-admissions(at 6 months)
- Change from baseline patient-centeredness(at 6 months)
- Change from baseline secondary diabetes self-management behaviors(at 6 months)
- Change from baseline self-efficacy in managing diabetes(at 6 months)
- Change from baseline diabetes distress(at 6 months)
- Change from baseline medication Adherence(at 6 months)