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Project CHEER (Comprehensive Headache Evaluation, Education, Relief)

This study has been completed.
Sponsor:
Collaborators:
Innovative Medical
Thomas Jefferson University
Information provided by:
Duke University
ClinicalTrials.gov Identifier:
NCT00417742
First received: January 2, 2007
Last updated: August 20, 2014
Last verified: January 2007
  Purpose

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 Intervention
Chronic Headache
Behavioral: Service delivery through a Headache Management Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Headache Management Programs

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Estimated Enrollment: 828
Study Start Date: June 2002
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417742

Locations
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
Innovative Medical
Thomas Jefferson University
Investigators
Principal Investigator: David B Matchar, MD Duke University
  More Information

Publications:
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

ClinicalTrials.gov Identifier: NCT00417742     History of Changes
Other Study ID Numbers: 0728, AHRQ Grant No.: 1 R01 HS10893, 0728-06-5R7ER
Study First Received: January 2, 2007
Last Updated: August 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
headache
migraine headache
tension headache

Additional relevant MeSH terms:
Headache
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014