Participatory Design of Patient-centered Depression and Diabetes Care

University of Pennsylvania

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Depression

Treatments: Behavioral: Education, encouragement, card sort; Behavioral: Education, encouragement

Study type: Interventional

Funder types: Other

Identifiers

NCT02178176

1K18HS023445-01

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

78 participants in 2 patient groups

Education, encouragement, card sort

Experimental group

Treatment:

Behavioral: Education, encouragement, card sort

Education, encouragement

Active Comparator group

Treatment:

Behavioral: Education, encouragement