Improving Self Management Skills of Older Adults With Diabetes

Not Applicable

Completed

• Conditions: Diabetes; Type 2 Diabetes
• Interventions: Behavioral: Diabetes Self Management Program

• Registration Number: NCT01943357
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-11
• Study First Posted: 2013-09-16
• Primary Completion: 2016-03
• Study Completion: 2017-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• type 2 diabetes
• WellPoint insurance or medicare supplement plan participant
• 18 years or older

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Exclusion Criteria

• Treatment for cancer in past year
• Pregnant
• Under 18
• Previously taken a Stanford self-management program

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diabetes Self-Management Program	Diabetes Self Management Program	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.

Primary Outcome Measures

Name	Time	Method
Metabolic control HbA1C	Baseline to 12 months

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States