Improving Self Management Skills of Older Adults With Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014