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Assessment of a Personalized Health Care Intervention for Frequent Headache

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Frequent Headaches

Intervention: Personalized health plan (Other)

Phase: N/A

Status: Completed

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Remy Coeytaux, MD, Principal Investigator, Affiliation: Duke


The research project is a component of a mentored research career enhancement award. The purpose of the award is to help the PI and his collaborators prepare for future research grant opportunities through the Patient Centered Outcomes Research Institute (PCORI). The research project is a feasibility study with the following specific aims; 1) to assess outcomes associated with a personalized health plan for frequent headaches; 2) to identify measurable outcomes that are meaningful to patients with frequent headaches; and 3) to create a patient stakeholder group to inform patient-centered outcomes research for frequent headaches. Specific Aim #1 will be achieved by recruiting and enrolling 40 established patients at the Duke Family Medicine Center who have frequent headaches. The intervention consists of 3 study visits with the PI, 2 clinical consultations with subjects' established primary care provider at the Duke Pickens Family Medicine Center, and participation in 2 focus groups. Personalized health plans might consist of a combination of medical management, lifestyle changes, nutrition counseling, or other therapeutic modalities as appropriate. Data analysis will be descriptive; no formal hypotheses will be tested.

Clinical Details

Official title: Assessment of a Personalized Health Care Intervention for Frequent Headache

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome:

Change in Daily headache scores,

Change in Quality of life


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- patients with chronic headache

Exclusion Criteria:

- patients who do not understand english language

Locations and Contacts

Additional Information

Starting date: August 2014
Last updated: July 17, 2015

Page last updated: August 23, 2015

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