Diabetes Mellitus, Type 2
Conditions
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.
Interventions
OTHERiDSMES
Intensive Diabetes Self-Management Education and Support combined with Addressing Social Determinants of Health
OTHERStandard of Care
Standard of Care for patients with type 2 diabetes
Sponsors
The University of Texas Medical Branch, Galveston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 13-84, and 2. Patients diagnosed with type 2 diabetes, and 3. Patients have a BMI equal to or \>25 (23, if Asians), and 4. Hemoglobin A1c value equal to or \>7%
Exclusion criteria
1. Ages \<13 or \>84 2. Pregnancy. If a subject becomes pregnant, they will advised to discontinue the study. 3. Previous diagnosis of type 1 diabetes 4. 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 5. Other medical condition or medication administration deemed exclusionary by the study investigators 6. Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline HbA1c | at 6 months | measurement of hemoglobin A1c (HbA1c %) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline blood pressure | at 6 months | measurement of systolic and diastolic blood pressure in mm Hg |
| Change from baseline lipid profile | at 6 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 6 months | Frequency of provider encounter |
| Change from baseline frequency of feet examination for neuropathy | at 6 months | Frequency of feet examination for neuropathy |
| Change from baseline frequency of urine exam for microalbuminuria | at 6 months | Frequency of urine exam for microalbuminuria |
| Change from baseline frequency of oral health checkup | at 6 months | Frequency of oral health checkup |
| Change from baseline frequency of eye fundus examination | at 6 months | Frequency of eye fundus examination |
| Change from baseline frequency of emergency care visits for treatment of T2-related issues | at 6 months | Frequency of emergency care visits for treatment of T2-related issues |
| Change from baseline weight | at 6 months | measurement of body weight in Kg |
| 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 patient-centeredness | at 6 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 secondary diabetes self-management behaviors | at 6 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 6 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 6 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 6 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. |
| Change from baseline frequency of hospitalizations and re-admissions | at 6 months | Frequency of hospitalizations and re-admissions |
Countries
United States
Outcome results
None listed