Clinical trial NCT01098253: Integrating Depression Services Into DM Management
Official title: Integrating Depression Services Into Type 2 Diabetes Mellitus Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Depression
Keywords: adherence
diabetes mellitus
depression
primary health care
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2010-04-02
Enrollment: 182
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this proposal is to integrate depression services into improving adherence for oral hypoglycemic agents so that a single program can assist patients. The investigators hypothesized that patients in the intervention would demonstrate improved adherence to patients' oral hypoglycemic agents and antidepressants as well as improved clinical outcomes.

Detailed description: Many older patients do not take their medications for Type 2 diabetes mellitus (DM) as prescribed by their physician. Depression is common among patients with Type 2 DM and may be the reason why patients do not take their medications as prescribed. A program in which Type 2 DM and depression are treated together in primary care would improve the health of older patients with both Type 2 diabetes and depression and would be practical in real world practices with competing demands for limited resources. There is an urgent need for research that can bring potentially life-extending strategies to older patients with both diabetes and depression. People can better control their Type 2 DM if they treat their depression and the same strategies can be used to help patients take their medications for both conditions. In this program patients were involved in identifying problems with taking their medicines and working on solutions. The aims of this program were to improve how patients take their medications for Type 2 DM and depression as well as blood glucose control and symptoms of depression over 3 months. To see whether this program works the investigators compared the results of patients receiving this program to those who do not receive the program. Findings may lead to the development of other programs in which depression and chronic medical conditions are treated together.

Eligibility criteria: Inclusion Criteria:

* 30 years and older
* a current diagnosis of Type 2 DM
* current prescription for an oral hypoglycemic agent
* current prescription for an antidepressant
* able to communicate in English
* willing to give informed consent.

Exclusion Criteria:

* inability to give informed consent
* significant cognitive impairment at baseline (Mini-Mental State Examination (MMSE) \<21)
* residence in a care facility that provides medications
* unwillingness or inability to use the Medication Event Monitoring System

Primary outcomes:
measure: Hemoglobin A1C
timeFrame: 3 months
Secondary outcomes:
measure: Nine Item Patient Health Questionnaire (PHQ-9)
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Hillary R. Bogner, MD
role: PRINCIPAL_INVESTIGATOR
References: