NCT01040806

Brief Summary

Patients with diabetes who are counseled by a peer coach (another patient with diabetes) will have improved glycemic control compared with usual care patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

1.7 years

First QC Date

December 28, 2009

Last Update Submit

March 7, 2022

Conditions

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c level

    6 months

Secondary Outcomes (1)

  • LDL cholesterol level

    6 months

Study Arms (2)

Health coaching

EXPERIMENTAL

Patients with poorly controlled diabetes will receive counseling from a peer health coach -- a patient with diabetes trained in health coaching

Behavioral: Health coaching

Usual care

ACTIVE COMPARATOR

Patients will receive usual care

Behavioral: Usual care

Interventions

Usual careBEHAVIORAL

Patients will receive their usual medical care

Usual care
Health coachingBEHAVIORAL

Peer health coaches will counsel patients with diabetes

Also known as: Peer coaching, Peer coach, Peer support
Health coaching

Eligibility Criteria

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

You may qualify if:

  • Diabetes with most recent HbA1c 8 or above in past 6 months.

You may not qualify if:

  • Dementia,
  • Life expectancy less than 6 months,
  • Inability to speak English or Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (2)

  • Ghorob A, Vivas MM, De Vore D, Ngo V, Bodenheimer T, Chen E, Thom DH. The effectiveness of peer health coaching in improving glycemic control among low-income patients with diabetes: protocol for a randomized controlled trial. BMC Public Health. 2011 Apr 1;11:208. doi: 10.1186/1471-2458-11-208.

    PMID: 21457567BACKGROUND
  • Thom DH, Ghorob A, Hessler D, De Vore D, Chen E, Bodenheimer TA. Impact of peer health coaching on glycemic control in low-income patients with diabetes: a randomized controlled trial. Ann Fam Med. 2013 Mar-Apr;11(2):137-44. doi: 10.1370/afm.1443.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Thomas Bodenheimer, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2009

First Posted

December 30, 2009

Study Start

August 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

March 21, 2022

Record last verified: 2022-03

Locations