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Project CHEER (Comprehensive Headache Evaluation, Education, Relief)

Primary Purpose

Chronic Headache

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Service delivery through a Headache Management Program
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Headache focused on measuring headache, migraine headache, tension headache

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente
  • Duke University Medical Center
  • Thomas Jefferson University

Outcomes

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.

Full Information

First Posted
January 2, 2007
Last Updated
August 20, 2014
Sponsor
Duke University
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Innovative Medical, Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT00417742
Brief Title
Project CHEER (Comprehensive Headache Evaluation, Education, Relief)
Official Title
A Randomized Trial of Headache Management Programs
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Duke University
Collaborators
Agency for Healthcare Research and Quality (AHRQ), Innovative Medical, Thomas Jefferson University

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Headache
Keywords
headache, migraine headache, tension headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
828 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Service delivery through a Headache Management Program
Primary Outcome Measure Information:
Title
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.
Title
The measure is taken by telephone at the screening interview and by mailed survey at basel
Secondary Outcome Measure Information:
Title
CATI headache diagnostic survey is administered by telephone at the screening interview to obtain a diagnosis of headache type.
Title
SF-36 Quality of Life Survey is administered by mailed survey at baseline and at 6 and 12 months
Title
Health Care Utilization Measures will include self-report by patients on the mailed surveys at baseline and at 3, 6 and 12 months.
Title
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.
Title
Patient reports will be validated by administrative utilization data and by a limited chart review at each site.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David B Matchar, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12890125
Citation
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.
Results Reference
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Project CHEER (Comprehensive Headache Evaluation, Education, Relief)

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