Integrating Depression Services Into DM Management

Study Overview
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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.

Official Title
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Integrating Depression Services Into Type 2 Diabetes Mellitus Management

Conditions
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Type 2 Diabetes Mellitus, Depression

Intervention / Treatment
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* Behavioral: Adherence Intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adherence Intervention<br>Factors affecting adherence to oral hypoglycemic agents and antidepressants were addressed using a problem solving process. | Behavioral: Adherence Intervention<br>* Factors affecting adherence are addressed using a problem solving process.<br>|
| No Intervention: Usual Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adherence, diabetes mellitus, depression, primary health care