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Clinical Trials/NCT02177019
NCT02177019
Completed
Not Applicable

Assessment of a Personalized Health Care Intervention for Frequent Headache

Duke University0 sites31 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Frequent Headaches
Sponsor
Duke University
Enrollment
31
Primary Endpoint
Change in Daily headache scores,
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
July 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients with chronic headache

Exclusion Criteria

  • patients who do not understand english language

Outcomes

Primary Outcomes

Change in Daily headache scores,

Time Frame: Daily from baseline to 3 months

Subjects will report daily headache scores to the CRC.

Change in Quality of life

Time Frame: Baseline to 3 months

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