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Improving Self Management Skills of Older Adults With Diabetes

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ClinicalTrials.gov Identifier: NCT01943357
Recruitment Status : Completed
First Posted : September 16, 2013
Last Update Posted : April 25, 2017
Sponsor:
Collaborator:
HealthCore, Inc.
Information provided by (Responsible Party):
Kate Lorig, 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Diabetes Behavioral: Diabetes Self Management Program Not Applicable

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  (Clinical Trial)
Actual Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Improving the Self Management Skills of Older Adults With Diabetes
Study Start Date : September 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


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 Name: Better Choices Better Health--Diabetes




Primary Outcome Measures :
  1. Metabolic control HbA1C [ Time Frame: Baseline to 12 months ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943357


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94306
Sponsors and Collaborators
Stanford University
HealthCore, Inc.
Investigators
Principal Investigator: Kate Lorig, DPH Stanford School of Medicine

Additional Information:
Responsible Party: Kate Lorig, professor emertius, Stanford University
ClinicalTrials.gov Identifier: NCT01943357     History of Changes
Other Study ID Numbers: 26679
109554 ( Other Grant/Funding Number: NCOA )
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017

Keywords provided by Kate Lorig, Stanford University:
diabetes
patient education
self management
health improvement

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases