Participatory Design of Patient-centered Depression and Diabetes Care

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT02178176

Collaborator

(none)

Enrollment

Location

Arms

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Type 2 Diabetes Mellitus	Behavioral: Education, encouragement, card sort Behavioral: Education, encouragement	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Education, encouragement, card sort	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.
Active Comparator: Education, encouragement	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: Education, encouragement, card sort

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.

Active Comparator: Education, encouragement

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hillary Bogner, Associate Professor, University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT02178176

Other Study ID Numbers:

1K18HS023445-01

First Posted:

Jun 30, 2014

Last Update Posted:

May 17, 2016

Last Verified:

May 1, 2016

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Depression

Depressive Disorder

Study Results

No Results Posted as of May 17, 2016