Improving Self Management Skills of Older Adults With Diabetes

Improving the Self Management Skills of Older Adults With Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes; Type 2 Diabetes
• Intervention / Treatment: Behavioral: Diabetes Self Management Program

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 Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94306
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Behavioral: Diabetes Self Management Program; The interventions include modeling and action-planning to enhance self-efficacy.; Other Names: Better Choices Better Health--Diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Metabolic control HbA1C	Baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: HealthCore, Inc.
• Investigators: Principal Investigator: Kate Lorig, DPH, Stanford School of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): February 1, 2017

Study Registration Dates

• First Submitted: September 9, 2013
• First Submitted That Met QC Criteria: September 11, 2013
• First Posted (ESTIMATE): September 16, 2013

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: diabetes; patient education; self management; health improvement
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 26679; 109554 (OTHER_GRANT: NCOA)