Depression, Type 2 Diabetes Mellitus
Conditions
Brief summary
The burden of diabetes is anticipated to grow yet the proportion of adults whose diabetes is controlled is decreasing over time. This project can have a significant public health impact because we are refining and pilot testing a primary-care based intervention aimed at improving patient engagement and function which are critical components of diabetes care and are associated with improved glycemic control, lower disease-related health-care expenditures, and reduced mortality.
Interventions
BEHAVIORALEducation, encouragement, card sort
Patients will identify factors involved in nonadherence. For each factor influencing adherence, the interventionist will engage the patient in a 4-step problem solving process. We will recognize patients' social and cultural context by addressing health-related priorities identified by the patient. The goal will be to identify those priorities which are likely to influence engagement in care and adherence to treatment. We will assess both biomedical (physical symptoms, diet and exercise) and nonbiomedical (financial, social and emotional) needs patients with Type 2 diabetes mellitus and depressive symptoms may wish to discuss in the context of their health. After the patients complete the card sort, interventionists will engage the patient in the 4-step problem solving process.
BEHAVIORALEducation, encouragement
Patients will identify factors involved in nonadherence. For each factor influencing adherence, the interventionist will engage the patient in a 4-step problem solving process.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years and older 2. a current diagnosis of Type 2 DM 3. HbA1c 7% 4. current prescription for an oral hypoglycemic agent 5. able to communicate in English 6. willing to give informed consent
Exclusion criteria
1. acutely suicidal or psychotic (patients will not be randomized and PI or physician covering for PI will be paged immediately) 2. significant cognitive impairment at baseline (a total score on Mini-Mental State Examination (MMSE) 21) 3. markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or NYHA Class III or IV congestive heart failure)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression: nine-item Patient Health Questionnaire (PHQ-9) | Baseline and 14 weeks |
| Glycemic control: hemoglobin A1c | Baseline and 14 weeks |
| Adherence to oral hypoglycemic agents: Medication Event Monitoring System | Over 14 weeks |
Countries
United States
Outcome results
None listed