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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

Tracking Information
First Submitted Date  ICMJE April 1, 2010
First Posted Date  ICMJE April 2, 2010
Results First Submitted Date  ICMJE November 29, 2011
Results First Posted Date  ICMJE March 9, 2012
Last Update Posted Date March 9, 2012
Study Start Date  ICMJE January 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2010)
Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 3 months ]
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Integrating Depression Services Into DM Management
Official Title  ICMJE Integrating Depression Services Into Type 2 Diabetes Mellitus Management
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Depression
Intervention  ICMJE Behavioral: Adherence Intervention
Factors affecting adherence are addressed using a problem solving process.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2012)
182
Original Estimated Enrollment  ICMJE
 (submitted: April 1, 2010)
280
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01098253
Other Study ID Numbers  ICMJE 1-09-CR-07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hillary Bogner, University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE American Diabetes Association
Investigators  ICMJE
Principal Investigator: Hillary R. Bogner, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date February 2012

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