Improving Self Management Skills of Older Adults With Diabetes

Overview

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.

Full Title of Study: “Improving the Self Management Skills of Older Adults With Diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2016

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.

Interventions

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

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Metabolic control HbA1C
    • Time Frame: Baseline to 12 months

Secondary Measures

  • Symptom:fatigue
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Stanford University
  • Collaborator
    • HealthCore, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kate Lorig, professor emertius – Stanford University
  • Overall Official(s)
    • Kate Lorig, DPH, Principal Investigator, Stanford School of Medicine

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