Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417742
Status:
COMPLETED
Last Update Posted:
2014-08-22
First Post:
2007-01-02
Brief Title:
Project CHEER Comprehensive Headache Evaluation Education Relief
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Randomized Trial of Headache Management Programs
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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 types 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
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 types 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 andor 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
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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0728-06-5R7ER | None | None | None |
| AHRQ Grant No 1 R01 HS10893 | None | None | None |