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Integrating Depression Services Into DM Management

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ClinicalTrials.gov Identifier: NCT01098253
Recruitment Status : Completed
First Posted : April 2, 2010
Results First Posted : March 9, 2012
Last Update Posted : March 9, 2012
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Hillary Bogner, University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Depression Behavioral: Adherence Intervention Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Integrating Depression Services Into Type 2 Diabetes Mellitus Management
Study Start Date : January 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Adherence Intervention
Factors affecting adherence to oral hypoglycemic agents and antidepressants were addressed using a problem solving process.
 Behavioral: Adherence Intervention
Factors affecting adherence are addressed using a problem solving process.
No Intervention: Usual Care


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01098253


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
American Diabetes Association
Investigators
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Principal Investigator: Hillary R. Bogner, MD University of Pennsylvania
More Information
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Responsible Party: Hillary Bogner, MD MSCE/ Assistant Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01098253    
Other Study ID Numbers: 1-09-CR-07
First Posted: April 2, 2010    Key Record Dates
Results First Posted: March 9, 2012
Last Update Posted: March 9, 2012
Last Verified: February 2012
Keywords provided by Hillary Bogner, University of Pennsylvania:
adherence
diabetes mellitus
depression
primary health care
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Depression
Depressive Disorder
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders