Project CHEER (Comprehensive Headache Evaluation, Education, Relief)

August 20, 2014 updated by: Duke University

A Randomized Trial of Headache Management Programs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

828

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92120
        • Kaiser Permanente
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Thomas Jefferson University
Agency for Healthcare Research and Quality (AHRQ)
Innovative Medical

Investigators

  • Principal Investigator: David B Matchar, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

January 2, 2007

First Submitted That Met QC Criteria

January 2, 2007

First Posted (Estimate)

January 4, 2007

Study Record Updates

Last Update Posted (Estimate)

August 22, 2014

Last Update Submitted That Met QC Criteria

August 20, 2014

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0728
  • AHRQ Grant No.: 1 R01 HS10893
  • 0728-06-5R7ER

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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