Participatory Design of Patient-centered Depression and Diabetes Care

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Education, encouragement, card sort

Behavioral

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

Behavioral

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 outcomes

Depression: nine-item Patient Health Questionnaire (PHQ-9)

Time frame: Baseline and 14 weeks
Glycemic control: hemoglobin A1c

Time frame: Baseline and 14 weeks
Adherence to oral hypoglycemic agents: Medication Event Monitoring System

Time frame: Over 14 weeks

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2015
First posted: Jun 30, 2014
Registry last updated: May 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed