Skip to main content
OpenTrials
Completed

NCT Number: NCT01098253

Integrating Depression Services Into DM Management

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Adherence intervention

Behavioral

Factors affecting adherence are addressed using a problem solving process.

Primary outcomes

  1. Hemoglobin A1C

    Time frame: 3 months

    HbA1c levels will be obtained in accordance with ADA guidelines (1) employing the in2it A1C Analyzer. The Analyzer offers accurate point of care HbA1c testing. Point of care testing using this device has acceptable precision and agreement in comparison with laboratory services

Secondary outcomes

  1. Nine Item Patient Health Questionnaire (PHQ-9)

    Time frame: 3 months

    Depressive symptoms were measured using the nine-item Patient Health Questionnaire (PHQ-9). PHQ-9 scored on a range from 0 to 27, where lower scores represent fewer depressive symptoms.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

Integrating Depression Services Into Type 2 Diabetes Mellitus Management

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 2, 2010
Registry last updated
Mar 9, 2012

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.