Participatory Design of Patient-centered Depression and Diabetes Care

Study Overview
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Brief Summary
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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.

Conditions
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Depression, Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Education, encouragement, card sort
* Behavioral: Education, encouragement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older a current diagnosis of Type 2 DM HbA1c 7% current prescription for an oral hypoglycemic agent able to communicate in English willing to give informed consent Exclusion Criteria: acutely suicidal or psychotic (patients will not be randomized and PI or physician covering for PI will be paged immediately) significant cognitive impairment at baseline (a total score on Mini-Mental State Examination (MMSE) 21) markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or NYHA Class III or IV congestive heart failure)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education, encouragement, card sort<br> | Behavioral: Education, encouragement, card sort<br>* 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.<br>|
| Active Comparator: Education, encouragement<br> | Behavioral: Education, encouragement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |