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Completed

NCT Number: NCT01943357

Improving 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.

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Key information

Conditions

Type 2 Diabetes Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diabetes Self Management Program

Behavioral

The interventions include modeling and action-planning to enhance self-efficacy.

Other names: Better Choices Better Health--Diabetes

Primary outcomes

  1. Metabolic control HbA1C

    Time frame: Baseline to 12 months

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • HealthCore, Inc.

Registry information

Official study title

Improving the Self Management Skills of Older Adults With Diabetes

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Sep 16, 2013
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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