NCT00417742

Brief Summary

PROJECT CHEER is a randomized controlled trial designed to test the effectiveness of a comprehensive focused approach to headache care. Three institutions are collaborating in this trial by establishing special Headache Programs that can provide individualized treatment and follow-up: Duke University Medical Center in Durham, NC; Thomas Jefferson University in Philadelphia, PA; and Kaiser Permanente in San Diego, CA. Support and oversight are provided by the U.S. Agency for Healthcare Research and Quality. HEADACHE sufferers age 18 and over whose headaches interfere with their ability to work, study or enjoy life are eligible for this trial. Half of the enrolled individuals will be selected at random to receive care in the Headache Program and half will continue to receive care as usual from their primary care providers. EVALUATION is an important part of this project. Every participant completes a screening interview and survey at the time of enrollment. The initial evaluation will provide an accurate diagnosis of headache type(s). The results of this evaluation will be reported to the primary care provider and may help to provide usual care. Subjects assigned to the Headache Program are further evaluated by the program manager in consultation with a headache specialist. EDUCATION in headache care is provided to participants assigned to the Headache Program. The classes include suggestions on diet and lifestyle as well as a review of medication use. Note: The above is excerpted from the flyer we distributed to recruit patients to the trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
828

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2002

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

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

June 1, 2002

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2007

Completed
Last Updated

August 22, 2014

Status Verified

January 1, 2007

First QC Date

January 2, 2007

Last Update Submit

August 20, 2014

Conditions

Chronic Headache

Keywords

headachemigraine headachetension headache

Outcome Measures

Primary Outcomes (2)

  • MIDAS, simple and accurate five-question survey that measures days lost to headache disability during the last 3 months and also headache pain on a 10-point scale.

  • The measure is taken by telephone at the screening interview and by mailed survey at basel

Secondary Outcomes (5)

  • CATI headache diagnostic survey is administered by telephone at the screening interview to obtain a diagnosis of headache type.

  • SF-36 Quality of Life Survey is administered by mailed survey at baseline and at 6 and 12 months

  • Health Care Utilization Measures will include self-report by patients on the mailed surveys at baseline and at 3, 6 and 12 months.

  • Patients are asked about their use of outpatient, inpatient and emergency room services, as well as use of alternative therapies (e.g., accupuncture, massage therpay, herbalists) and prescription and nonprescription drugs.

  • Patient reports will be validated by administrative utilization data and by a limited chart review at each site.

Interventions

Service delivery through a Headache Management ProgramBEHAVIORAL

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 21 or over
  • have chronic headache thought to be of tension-type, migraine or mixed etiology
  • intend to continue headache care at their current location for the next six months
  • MIDAS score \>5

You may not qualify if:

  • Under age 21
  • Currently seeing a neurologist for headache care
  • Currently being seen in a Headache Clinic
  • MIDAS score \<5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kaiser Permanente

San Diego, California, 92120, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • Harpole LH, Samsa GP, Jurgelski AE, Shipley JL, Bernstein A, Matchar DB. Headache management program improves outcome for chronic headache. Headache. 2003 Jul-Aug;43(7):715-24. doi: 10.1046/j.1526-4610.2003.03128.x.

    PMID: 12890125BACKGROUND

MeSH Terms

Conditions

Headache DisordersHeadacheMigraine DisordersTension-Type Headache

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, Primary

Study Officials

  • David B Matchar, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 2, 2007

First Posted

January 4, 2007

Study Start

June 1, 2002

Study Completion

December 1, 2004

Last Updated

August 22, 2014

Record last verified: 2007-01

Locations

US(3)