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| ID | Type | Description | Link |
|---|---|---|---|
| 109554 | Other Grant/Funding Number | NCOA |
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| Name | Class |
|---|---|
| HealthCore, Inc. | INDUSTRY |
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The study will help determine if the Better Choices Better Health Diabetes program (community-based or online, also known as the Diabetes Self-Management Program) improves the hbA1C of people with Type-II diabetes. The investigators will also examine 1) symptoms (fatigue, sleep, low blood sugar symptoms, depression, shortness of breath), 2) healthy behaviors (blood sugar monitoring; taking medications as prescribed; getting eye, foot, kidney and cholesterol exams; and activity), 3) the use of health care services. This project is a translational study to demonstrate the effectiveness of the intervention in the context of a major insurer.
Self-report questionnaires and hbA1c capillary blood collection kits will be administered at baseline (prior to the intervention), six-months and twelve-months. Differences between baseline and followup scores will be used to determine if participants have benefited from the intervention, using intent-to-treat methodology. Subgroups and delivery method (small-group or on-line) will be compared using repeated measures and analyses of covariance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Self-Management Program | Experimental | Behavioral: Diabetes Self Management Program. Consists of either a six-week small-group face-to-face program with two peer leaders or an six-week peer-facilitated Internet-based program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Self Management Program | Behavioral | The interventions include modeling and action-planning to enhance self-efficacy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Metabolic control HbA1C | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom:fatigue | Single item visual numeric scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if change significant. | Baseline to 12 months |
| symptom: sleep | Single item visual numeric scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if change significant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kate Lorig, DPH | Stanford School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94306 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Baseline to 12 months |
| symptom: PHQ-8 depression | 8-item scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant. | Baseline to 12 months |
| symptoms: hypoglycemic index | 7-item scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant. | Baseline to 12 months |
| health behavior: blood glucose monitoring | Self report of how often monitor glucose at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant. | Baseline to 12 months |
| health behavior: medication adherence | 3-item scale collected at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant. | baseline to 12 months |
| Health behavior: communication with physician | 3-item scale collected at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant. | baseline to 12 months |
| health behavior: exercise | Minutes of exercise during last week self-reported at baseline, 6-months and 12-months. Paired t-tests used to assess if any changes are significant. | baseline to 12 months |
| health behavior/utilization: frequency of exams | Self report of how often examine feet and have eye, cholesterol and kidney levels tested. Collected at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant. | baseline to 12 months |
| Health care utilization | Physician, ED, hospital visits in last six-months. Self reported at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant. | baseline to 12 months |