Depression, Type 2 Diabetes Mellitus
Conditions
Keywords
adherence, diabetes mellitus, depression, primary health care
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.
Interventions
BEHAVIORALAdherence Intervention
Factors affecting adherence are addressed using a problem solving process.
Sponsors
American Diabetes Association
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C | 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Nine Item Patient Health Questionnaire (PHQ-9) | 3 months | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Integrated Care Intervention 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. | 94 |
| Usual Care | 88 |
| Total | 182 |
Baseline characteristics
| Characteristic | Integrated Care Intervention | Usual Care | Total |
|---|---|---|---|
| Age Continuous | 57.8 Years STANDARD_DEVIATION 9.4 | 57.1 Years STANDARD_DEVIATION 9.6 | 57.4 Years STANDARD_DEVIATION 10.3 |
| Region of Enrollment United States | 94 participants | 88 participants | 182 participants |
| Sex: Female, Male Female | 64 Participants | 58 Participants | 122 Participants |
| Sex: Female, Male Male | 30 Participants | 30 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 94 | 0 / 88 |
| serious Total, serious adverse events | 0 / 94 | 0 / 88 |
Outcome results
Primary
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
Population: Analysis proceeded at the patient level and patients were analyzed according to the treatment to which they were randomized (intent-to-treat).
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Integrated Care Intervention | Hemoglobin A1C | 60.9 Percentage of participants with HbA1c <7 | 1.8 |
| Usual Care | Hemoglobin A1C | 35.7 Percentage of participants with HbA1c <7 | 1.9 |
Secondary
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
Population: Analysis proceeded at the patient level and patients were analyzed according to the treatment to which they were randomized (intent-to-treat).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Integrated Care Intervention | Nine Item Patient Health Questionnaire (PHQ-9) | 58.7 Percentage of participants with PHQ-9 <5 |
| Usual Care | Nine Item Patient Health Questionnaire (PHQ-9) | 30.7 Percentage of participants with PHQ-9 <5 |