A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Other: iDSMESOther: Standard of Care
- Registration Number
- NCT05097534
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 150
- 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%
- 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
- Prisoners
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description iDSMES 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. Standard of Care Standard of Care Eligible study subjects randomized to the intervention arm will receive standard of care offered to patients with diabetes.
- Primary Outcome Measures
Name Time Method Change from baseline HbA1c at 12 months measurement of hemoglobin A1c (HbA1c %)
- Secondary Outcome Measures
Name Time Method Change from baseline blood pressure at 12 months measurement of systolic and diastolic blood pressure in mm Hg
Change from baseline weight at 12 months measurement of body weight in Kg
Change from baseline lipid profile at 12 months measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL
Change from baseline frequency of provider encounter at 12 months Frequency of provider encounter
Change from baseline frequency of feet examination for neuropathy at 12 months Frequency of feet examination for neuropathy
Change from baseline frequency of urine exam for microalbuminuria at 12 months Frequency of urine exam for microalbuminuria
Change from baseline frequency of oral health checkup at 12 months Frequency of oral health checkup
Change from baseline frequency of eye fundus examination at 12 months Frequency of eye fundus examination
Change from baseline patient-centeredness at 12 months General self-rated Health (GSRH): a single item survey- self-administered single question such as "in general, would you say that your health is? excellent, very good, good, fair, or poor?", where excellent is scored as "5" and poor is scored as "0".
Change from baseline frequency of emergency care visits for treatment of T2-related issues at 12 months Frequency of emergency care visits for treatment of T2-related issues
Change from baseline frequency of hospitalizations and re-admissions at 12 months Frequency of hospitalizations and re-admissions
Participation in iDSMES classes (for those in the intervention arm only) at 12 months Participation in iDSMES classes (total number of sessions attended)
Lifestyle change outcomes (for those in the intervention arm only) every session through study completion, an average of 1 year Physical activity minutes in the last week prior to session
Change from baseline secondary diabetes self-management behaviors at 12 months fifty-six-item survey. This includes a series of secondary diabetes self-management behaviors to explore mediating factors that might influence changes in glycemic control. We will assess the proportion of individuals with severe hypoglycemic episodes and use the brief modified Block seven-item diet screener with a four-week time horizon to determine the number of servings per day of fruit and vegetables.
Change from baseline self-efficacy in managing diabetes at 12 months This self-management resource center validated eight-item survey on patient confidence in performing certain activities. The survey is scored from 0 to 10 on a visual analog scale (VAS).
Change from baseline diabetes distress at 12 months a two-item screening tool on 17 potential problems in the life of patients with diabetes. Patients are asked to score the distress ensuing from each problem during the last month from 1 to 6, where 1 is "Not a problem" and 6 is "a very serious problem".
Change from baseline medication Adherence at 12 months "Morisky Green Levine" Medication Adherence Scale: a four-item tool queries about forgetfulness, carelessness, and feelings around taking medications, scored from 0 to 4.
Trial Locations
- Locations (1)
St. Vincent House Clinic
🇺🇸Galveston, Texas, United States