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Integrating Depression Services Into DM Management

Primary Purpose

Type 2 Diabetes Mellitus, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adherence Intervention
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring adherence, diabetes mellitus, depression, primary health care

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adherence Intervention

Usual Care

Arm Description

Factors affecting adherence to oral hypoglycemic agents and antidepressants were addressed using a problem solving process.

Outcomes

Primary Outcome Measures

Hemoglobin A1C
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

Nine Item Patient Health Questionnaire (PHQ-9)
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.

Full Information

First Posted
April 1, 2010
Last Updated
February 8, 2012
Sponsor
University of Pennsylvania
Collaborators
American Diabetes Association
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1. Study Identification

Unique Protocol Identification Number
NCT01098253
Brief Title
Integrating Depression Services Into DM Management
Official Title
Integrating Depression Services Into Type 2 Diabetes Mellitus Management
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
American Diabetes Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Depression
Keywords
adherence, diabetes mellitus, depression, primary health care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adherence Intervention
Arm Type
Experimental
Arm Description
Factors affecting adherence to oral hypoglycemic agents and antidepressants were addressed using a problem solving process.
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Adherence Intervention
Intervention Description
Factors affecting adherence are addressed using a problem solving process.
Primary Outcome Measure Information:
Title
Hemoglobin A1C
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
Secondary Outcome Measure Information:
Title
Nine Item Patient Health Questionnaire (PHQ-9)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillary R. Bogner, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Integrating Depression Services Into DM Management

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