Improving Self Management Skills of Older Adults With Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 28, 2014
Last verified: July 2014

September 9, 2013
July 28, 2014
September 2013
March 2016   (final data collection date for primary outcome measure)
Metabolic control HbA1C [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01943357 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Type 2 Diabetes
Behavioral: Diabetes Self Management Program
The interventions include modeling and action-planning to enhance self-efficacy.
Other Name: Better Choices Better Health--Diabetes
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.
Intervention: Behavioral: Diabetes Self Management Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1400
March 2017
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01943357
26679, 109554
No
Kate Lorig, Stanford University
Stanford University
HealthCore, Inc.
Principal Investigator: Kate Lorig, DPH Stanford School of Medicine
Stanford University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP