Integrating Depression Services Into DM Management

NCT ID: NCT01098253

Last Updated: 2012-03-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-04-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Adherence Intervention

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

Group Type EXPERIMENTAL

Adherence Intervention

Intervention Type BEHAVIORAL

Factors affecting adherence are addressed using a problem solving process.

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adherence Intervention

Factors affecting adherence are addressed using a problem solving process.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

American Diabetes Association

OTHER

Sponsor Role collaborator

Responsible Party

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Hillary Bogner

MD MSCE/ Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hillary R. Bogner, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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1-09-CR-07

Identifier Type: -

Identifier Source: org_study_id

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