Improving Self Management Skills of Older Adults With Diabetes

NCT ID: NCT01943357

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-02-28

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.

Conditions

Type 2 Diabetes; Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Diabetes Self Management Program

Intervention Type: BEHAVIORAL

The interventions include modeling and action-planning to enhance self-efficacy.

Interventions

Diabetes Self Management Program

The interventions include modeling and action-planning to enhance self-efficacy.

Intervention Type: BEHAVIORAL

Other Intervention Names

Better Choices Better Health--Diabetes

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HealthCore, Inc.

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Kate Lorig

professor emertius

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kate Lorig, DPH

Role: PRINCIPAL_INVESTIGATOR

Stanford School of Medicine

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

109554

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

26679

Identifier Type: -

Identifier Source: org_study_id