NCT01943357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

2.5 years

First QC Date

September 9, 2013

Last Update Submit

April 24, 2017

Conditions

Keywords

diabetespatient educationself managementhealth improvement

Outcome Measures

Primary Outcomes (1)

  • Metabolic control HbA1C

    Baseline to 12 months

Secondary Outcomes (10)

  • Symptom:fatigue

    Baseline to 12 months

  • symptom: sleep

    Baseline to 12 months

  • symptom: PHQ-8 depression

    Baseline to 12 months

  • symptoms: hypoglycemic index

    Baseline to 12 months

  • health behavior: blood glucose monitoring

    Baseline to 12 months

  • +5 more secondary outcomes

Study Arms (1)

Diabetes Self-Management Program

EXPERIMENTAL

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

Interventions

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

Also known as: Better Choices Better Health--Diabetes
Diabetes Self-Management Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes
  • WellPoint insurance or medicare supplement plan participant
  • years or older

You may not qualify if:

  • Treatment for cancer in past year
  • Pregnant
  • Under 18
  • Previously taken a Stanford self-management program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94306, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kate Lorig, DPH

    Stanford School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor emertius

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 16, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2016

Study Completion

February 1, 2017

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations