Project CHEER (Comprehensive Headache Evaluation, Education, Relief)

Chronic Headache Clinical Trial

Official title:

A Randomized Trial of Headache Management Programs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417742
• Other study ID #: 0728
• Secondary ID: AHRQ Grant No.:
• Status: Completed
• Phase: N/A
• First received: January 2, 2007
• Last updated: August 20, 2014
• Start date: June 2002
• Est. completion date: December 2004

Study information

• Verified date: January 2007
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 828
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Headache
• Headache

Intervention

Behavioral:
• Service delivery through a Headache Management Program

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Kaiser Permanente	San Diego	California

Sponsors (4)

Lead Sponsor	Collaborator
Duke University	Agency for Healthcare Research and Quality (AHRQ), Innovative Medical, Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	The measure is taken by telephone at the screening interview and by mailed survey at basel
Secondary	CATI headache diagnostic survey is administered by telephone at the screening interview to obtain a diagnosis of headache type.
Secondary	SF-36 Quality of Life Survey is administered by mailed survey at baseline and at 6 and 12 months
Secondary	Health Care Utilization Measures will include self-report by patients on the mailed surveys at baseline and at 3, 6 and 12 months.
Secondary	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.
Secondary	Patient reports will be validated by administrative utilization data and by a limited chart review at each site.