Diabetes, Type 2 Diabetes
Conditions
Keywords
diabetes, patient education, self management, health improvement
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALDiabetes Self Management Program
The interventions include modeling and action-planning to enhance self-efficacy.
Sponsors
HealthCore, Inc.
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes * WellPoint insurance or medicare supplement plan participant * 18 years or older
Exclusion criteria
* Treatment for cancer in past year * Pregnant * Under 18 * Previously taken a Stanford self-management program
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Metabolic control HbA1C | Baseline to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| symptom: sleep | Baseline to 12 months | Single item visual numeric scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if change significant. |
| symptom: PHQ-8 depression | Baseline to 12 months | 8-item scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant. |
| symptoms: hypoglycemic index | Baseline to 12 months | 7-item scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant. |
| health behavior: blood glucose monitoring | Baseline to 12 months | 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. |
| Symptom:fatigue | Baseline to 12 months | Single item visual numeric scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if change significant. |
| Health behavior: communication with physician | baseline to 12 months | 3-item scale collected at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant. |
| health behavior: exercise | baseline to 12 months | 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. |
| health behavior/utilization: frequency of exams | baseline to 12 months | 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. |
| Health care utilization | baseline to 12 months | 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. |
| health behavior: medication adherence | baseline to 12 months | 3-item scale collected at baseline, 6 months and 12 months. Paired t-tests used to assess if any changes are significant. |
Countries
United States
Outcome results
None listed