An interventional study of Adherence Intervention in Type 2 Diabetes Mellitus and Depression, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2012-03-09.
Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 182 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
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Exclusion Criteria:
Factors affecting adherence to oral hypoglycemic agents and antidepressants were addressed using a problem solving process.
Behavioral: Adherence Intervention
Factors affecting adherence are addressed using a problem solving process.
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
Time frame: 3 months
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.
Time frame: 3 months
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.
| Milestone | Integrated Care Intervention | Usual Care |
|---|---|---|
| Started | 94 | 88 |
| Completed | 92 | 88 |
| Not completed | 2 | 0 |
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
| Percentage of participants with HbA1c <7 | Integrated Care Intervention | Usual Care |
|---|---|---|
| Hemoglobin A1C | 60.9 ± 1.8 | 35.7 ± 1.9 |
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.
| Percentage of participants with PHQ-9 <5 | Integrated Care Intervention | Usual Care |
|---|---|---|
| Nine Item Patient Health Questionnaire (PHQ-9) | 58.7 | 30.7 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Integrated Care Intervention | — | 0/94 (0%) | 0/94 (0%) |
| Usual Care | — | 0/88 (0%) | 0/88 (0%) |
| Age Continuous(Years) | Integrated Care Intervention | Usual Care | Total |
|---|---|---|---|
| Mean | 57.8 ± 9.4 | 57.1 ± 9.6 | 57.4 ± 10.3 |
| Sex: Female, Male(Participants) | Integrated Care Intervention | Usual Care | Total |
|---|---|---|---|
| Female | 64 | 58 | 122 |
| Male | 30 | 30 | 60 |
| Region of Enrollment(participants) | Integrated Care Intervention | Usual Care | Total |
|---|---|---|---|
| United States | 94 | 88 | 182 |
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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University of Pennsylvania