Improving Self Management Skills of Older Adults With Diabetes

Diabetes Clinical Trial

Official title:

Improving the Self Management Skills of Older Adults With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943357
• Other study ID #: 26679
• Secondary ID: 109554
• Status: Completed
• Phase: N/A
• First received: September 9, 2013
• Last updated: April 24, 2017
• Start date: September 2013
• Est. completion date: February 2017

Study information

• Verified date: April 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: February 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Behavioral:
• Diabetes Self Management Program
The interventions include modeling and action-planning to enhance self-efficacy.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	HealthCore, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic control HbA1C		Baseline to 12 months
Secondary	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
Secondary	symptom: sleep	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Stanford Patient Education Research Center