Participatory Design of Patient-centered Depression and Diabetes Care
Primary Purpose
Depression, Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education, encouragement, card sort
Education, encouragement
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
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)
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Education, encouragement, card sort
Education, encouragement
Arm Description
Outcomes
Primary Outcome Measures
Depression: nine-item Patient Health Questionnaire (PHQ-9)
Glycemic control: hemoglobin A1c
Adherence to oral hypoglycemic agents: Medication Event Monitoring System
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02178176
Brief Title
Participatory Design of Patient-centered Depression and Diabetes Care
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Education, encouragement, card sort
Arm Type
Experimental
Arm Title
Education, encouragement
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Education, encouragement, card sort
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education, encouragement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression: nine-item Patient Health Questionnaire (PHQ-9)
Time Frame
Baseline and 14 weeks
Title
Glycemic control: hemoglobin A1c
Time Frame
Baseline and 14 weeks
Title
Adherence to oral hypoglycemic agents: Medication Event Monitoring System
Time Frame
Over 14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Participatory Design of Patient-centered Depression and Diabetes Care
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