Participatory Design of Patient-centered Depression and Diabetes Care

Not Applicable

Completed

• Conditions: Depression; Type 2 Diabetes Mellitus
• Interventions: Behavioral: Education, encouragement; Behavioral: Education, encouragement, card sort

• Registration Number: NCT02178176
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-06-27
• Study First Posted: 2014-06-30
• Primary Completion: 2015-02
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-13
• Last Update Posted: 2016-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Education, encouragement	Education, encouragement	-
Education, encouragement, card sort	Education, encouragement, card sort	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States