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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Type 2 Diabetes Mellitus
Depression
Intervention Behavioral: Adherence Intervention
Enrollment 182
Recruitment Details Patients were recruited from three primary care practices in Philadelphia, Pennsylvania. The protocol was approved by the University of Pennsylvania Institutional Review Board. From April 2010 to April 2011, patients were identified and enrolled.
Pre-assignment Details This trial consisted of two phases: the run-in phase and the randomized controlled trial phase. The purpose of the 2-week run-in phase was to collect pre-intervention adherence rates for all patients.
Arm/Group Title Integrated Care Intervention Usual Care
Hide Arm/Group Description We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status. [Not Specified]
Period Title: Overall Study
Started 94 88
Completed 92 88
Not Completed 2 0
Arm/Group Title Integrated Care Intervention Usual Care Total
Hide Arm/Group Description We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status. [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 94 88 182
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 94 participants 88 participants 182 participants
57.8  (9.4) 57.1  (9.6) 57.4  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 88 participants 182 participants
Female
64
  68.1%
58
  65.9%
122
  67.0%
Male
30
  31.9%
30
  34.1%
60
  33.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 94 participants 88 participants 182 participants
94 88 182
1.Primary Outcome
Title Hemoglobin A1C
Hide Description 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
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis proceeded at the patient level and patients were analyzed according to the treatment to which they were randomized (intent-to-treat).
Arm/Group Title Integrated Care Intervention Usual Care
Hide Arm/Group Description:
We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
[Not Specified]
Overall Number of Participants Analyzed 92 88
Measure Type: Number
Unit of Measure: Percentage of participants with HbA1c <7
60.9 35.7
2.Secondary Outcome
Title Nine Item Patient Health Questionnaire (PHQ-9)
Hide Description 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.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis proceeded at the patient level and patients were analyzed according to the treatment to which they were randomized (intent-to-treat).
Arm/Group Title Integrated Care Intervention Usual Care
Hide Arm/Group Description:
We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
[Not Specified]
Overall Number of Participants Analyzed 92 88
Measure Type: Number
Unit of Measure: Percentage of participants with PHQ-9 <5
58.7 30.7
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Integrated Care Intervention Usual Care
Hide Arm/Group Description We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status. [Not Specified]
All-Cause Mortality
Integrated Care Intervention Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Integrated Care Intervention Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/94 (0.00%)   0/88 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Integrated Care Intervention Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/94 (0.00%)   0/88 (0.00%) 
Our primary care sites might not be representative of most primary care practices. Patients in the usual care group did not have the same number of in person contacts as those in the integrated care intervention to control for attention.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Hillary R Bogner
Organization: University of Pennsylvania, Perelman School of Medicine
Phone: 215-746-4181
EMail: hillary.bogner@uphs.upenn.edu
Layout table for additonal information
Responsible Party: Hillary Bogner, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01098253    
Other Study ID Numbers: 1-09-CR-07
First Submitted: April 1, 2010
First Posted: April 2, 2010
Results First Submitted: November 29, 2011
Results First Posted: March 9, 2012
Last Update Posted: March 9, 2012