Participatory Design of Patient-centered Depression and Diabetes Care

Depression Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02178176
• Other study ID #: 1K18HS023445-01
• Status: Not yet recruiting
• Phase: N/A
• First received: June 26, 2014
• Last updated: July 25, 2014
• Start date: July 2014

Study information

• Verified date: July 2014
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Agency for Healthcare Research and Quality:
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Education, 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.
• Education, 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression: nine-item Patient Health Questionnaire (PHQ-9)		Baseline and 14 weeks	No
Primary	Glycemic control: hemoglobin A1c		Baseline and 14 weeks	No
Primary	Adherence to oral hypoglycemic agents: Medication Event Monitoring System		Over 14 weeks	No