Project CHEER (Comprehensive Headache Evaluation, Education, Relief)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00417742
Recruitment Status : Completed
First Posted : January 4, 2007
Last Update Posted : August 22, 2014
Agency for Healthcare Research and Quality (AHRQ)
Innovative Medical
Thomas Jefferson University
Information provided by:
Duke University

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.

Condition or disease Intervention/treatment Phase
Chronic Headache Behavioral: Service delivery through a Headache Management Program Not Applicable

Detailed Description:

The purpose of this study is to determine whether headache management programs should be promoted as a preferred strategy for managing patients with chronic disabling headache.

Chronic headache affects between 6% and 17% of the population and is associated with significant numbers of days lost from work and reduced quality of life, as well as disproportionate use of medical resources. Current treatment is sub-optimal, with patients often not adequately diagnosed and/or not receiving appropriate preventive and acute pharmacologic therapy or behavioral modification. As a result, chronic headache is associated with sub-optimal quality of care, high patient dissatisfaction as well as high cost to individuals, insurers, and society.

The specific hypothesis of this study is that a properly designed headache management program (HMP) will reduce headache-related disability, improve process of care, and reduce management costs for patients with chronic headache. The format is a randomized controlled trial in which a patient population participating in a HMP will be compared with a corresponding patient population receiving usual care. A pilot study1 has determined the components of an optimal HMP and the effectiveness of a prototype of this service with a limited number of patients at a Kaiser Permanente facility in Santa Rosa, California.

Study Type : Interventional  (Clinical Trial)
Enrollment : 828 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Headache Management Programs
Study Start Date : June 2002
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Primary Outcome Measures :
  1. 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.
  2. The measure is taken by telephone at the screening interview and by mailed survey at basel

Secondary Outcome Measures :
  1. CATI headache diagnostic survey is administered by telephone at the screening interview to obtain a diagnosis of headache type.
  2. SF-36 Quality of Life Survey is administered by mailed survey at baseline and at 6 and 12 months
  3. Health Care Utilization Measures will include self-report by patients on the mailed surveys at baseline and at 3, 6 and 12 months.
  4. 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.
  5. Patient reports will be validated by administrative utilization data and by a limited chart review at each site.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00417742

United States, California
Kaiser Permanente
San Diego, California, United States, 92120
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Duke University
Agency for Healthcare Research and Quality (AHRQ)
Innovative Medical
Thomas Jefferson University
Principal Investigator: David B Matchar, MD Duke University

Harpole LH, Samsa GP, Jurgelski AE, Shipley JL, Bernstein A, Matchar DB. Headache management program improves outcome for chronic headache sufferers. Cephalalgia 1999;19:1-8 Identifier: NCT00417742     History of Changes
Other Study ID Numbers: 0728
AHRQ Grant No.: 1 R01 HS10893
First Posted: January 4, 2007    Key Record Dates
Last Update Posted: August 22, 2014
Last Verified: January 2007

Keywords provided by Duke University:
migraine headache
tension headache

Additional relevant MeSH terms:
Headache Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases