Improving Self Management Skills of Older Adults With Diabetes

This study is currently recruiting participants.
Verified October 2013 by Stanford University
Sponsor:
Collaborator:
HealthCore, Inc.
Information provided by (Responsible Party):
Kate Lorig, Stanford University
ClinicalTrials.gov Identifier:
NCT01943357
First received: September 9, 2013
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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 Intervention
Type 2 Diabetes
Behavioral: Diabetes Self Management Program

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Improving the Self Management Skills of Older Adults With Diabetes

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Metabolic control HbA1C [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom:fatigue [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1400
Study Start Date: September 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01943357

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94306
Contact: Kate Lorig, DrPH    650-723-7935    diabetes@stanford.edu   
Principal Investigator: Kate Lorig, DrPH         
Sponsors and Collaborators
Stanford University
HealthCore, Inc.
Investigators
Principal Investigator: Kate Lorig, DPH Stanford School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Kate Lorig, professor emertius, Stanford University
ClinicalTrials.gov Identifier: NCT01943357     History of Changes
Other Study ID Numbers: 26679, 109554
Study First Received: September 9, 2013
Last Updated: October 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
diabetes
patient education
self management

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 22, 2014