Participatory Design of Patient-centered Depression and Diabetes Care
1 other identifier
interventional
78
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 26, 2014
CompletedFirst Posted
Study publicly available on registry
June 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedMay 17, 2016
May 1, 2016
1.4 years
June 26, 2014
May 13, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Education, encouragement, card sort
EXPERIMENTALEducation, encouragement
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 26, 2014
First Posted
June 30, 2014
Study Start
September 1, 2013
Primary Completion
February 1, 2015
Last Updated
May 17, 2016
Record last verified: 2016-05