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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
1,000
The interventions include modeling and action-planning to enhance self-efficacy.
Stanford University School of Medicine
Stanford, California, United States
Metabolic control HbA1C
Time frame: Baseline to 12 months
Symptom:fatigue
Single item visual numeric scale. Examined at baseline, 6 months and 12 months. Paired t-tests used to assess if change significant.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline to 12 months
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