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Integrating Depression Services Into DM Management

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Hillary Bogner, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01098253
First received: April 1, 2010
Last updated: February 8, 2012
Last verified: February 2012
History of Changes

April 1, 2010
February 8, 2012
January 2009
April 2011   (final data collection date for primary outcome measure)
Hemoglobin A1C [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01098253 on ClinicalTrials.gov Archive Site
Nine Item Patient Health Questionnaire (PHQ-9) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The Centers for Epidemiologic Studies Depression (CES-D) scale was developed by the Center for Epidemiologic Studies at the National Institute of Mental Health for use in studies of depression in community samples to measure self-reported depression symptoms
Not Provided
Not Provided
 
Integrating Depression Services Into DM Management
Integrating Depression Services Into Type 2 Diabetes Mellitus 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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Depression
Behavioral: Adherence Intervention
Factors affecting adherence are addressed using a problem solving process.
  • Experimental: Adherence Intervention
    Factors affecting adherence to oral hypoglycemic agents and antidepressants were addressed using a problem solving process.
    Intervention: Behavioral: Adherence Intervention
  • No Intervention: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
182
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01098253
1-09-CR-07
Yes
Hillary Bogner, University of Pennsylvania
University of Pennsylvania
American Diabetes Association
Principal Investigator: Hillary R. Bogner, MD University of Pennsylvania
University of Pennsylvania
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP