Chronic HeadacheNCT00417742
Project CHEER (Comprehensive Headache Evaluation, Education, Relief)
A study testing Service delivery through a Headache Management Program in people with Chronic Headache, run by Duke University at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Headache
- What is being tested?
- Service delivery through a Headache Management Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 828 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2002to Dec 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Under age 21
- Currently seeing a neurologist for headache care
- Currently being seen in a Headache Clinic
- MIDAS score <5
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke University Medical Center
Durham, North Carolina, 27710
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Kaiser Permanente
San Diego, California, 92120
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Chronic Headache
- Being tested
- Service delivery through a Headache Management Program
- Keywords
- headache, migraine headache, tension headache
- Medical subject headings
- Headache Disorders, Headache, Migraine Disorders, Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Service delivery through a Headache Management ProgramBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (5)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2007 (estimated)
- Study startJun 2002
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic HeadacheStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 828 participants
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Innovative Medical, Thomas Jefferson University
- Investigators
- David B Matchar, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417742
- Sponsor's protocol ID
- 0728
- Other IDs
- AHRQ Grant No.: 1 R01 HS10893, 0728-06-5R7ER
- Status last verified
- Jan 2007
- First submitted
- 2 Jan 2007
- Last updated
- 22 Aug 2014
- Results posted
- No
Publications
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.
PubMed 12890125
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Headache Management Programs
- ClinicalTrials.gov ID
- NCT00417742
- Acronym / sponsor ID
- 0728
- Conditions
- Chronic Headache
- Keywords
- headache, migraine headache, tension headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 828 participants
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Innovative Medical, Thomas Jefferson University
- Study start
- Jun 2002
- Study completion
- Dec 2004
- First posted
- 4 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Under age 21
- Currently seeing a neurologist for headache care
- Currently being seen in a Headache Clinic
- MIDAS score <5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Service delivery through a Headache Management Program | Behavioural | – |
Primary outcome
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
5 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
- Background: PubMed 12890125Harpole 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.
Related trials for Chronic Headache
Not yet recruiting
Laser Acupuncture for Chronic Migraine: Clinical Response, Traditional Chinese Medicine Syndrome Patterns, and Brain Function
Chronic Migraine Headache
Active, not recruitingPhase 3
A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine
Migraine
RecruitingObservational study
Overlapping Pain Trajectory Study
Migraine, Musculoskeletal Pain
Not yet recruiting
EMBRACE Study: Enduring Migraine Benefit From Responsive Artery Coil Embolization
Migraine Disorders, Refractory Migraine
Not yet recruitingObservational study
Psychological Support for Chronic Migraine Patients Treated With Anti-CGRP (Anti-Calcitonin Gene-Related Peptide ) Monoclonal Antibodies
Chronic Migraine Headache, Psychologic Adaptation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David B Matchar, MD principal investigator
Duke University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Service delivery through a Headache Management Program in people with Chronic Headache, run by Duke University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00417742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2014.