Assessment of a Personalized Health Care Intervention for Frequent Headache
Primary Purpose
Frequent Headaches
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Personalized health plan
Sponsored by
About this trial
This is an interventional prevention trial for Frequent Headaches focused on measuring frequent headaches, personalized health plan
Eligibility Criteria
Inclusion Criteria:
- patients with chronic headache
Exclusion Criteria:
- patients who do not understand english language
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Development of personal health plan
Arm Description
Personal Health Plan
Outcomes
Primary Outcome Measures
Change in Daily headache scores,
Subjects will report daily headache scores to the CRC.
Change in Quality of life
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02177019
Brief Title
Assessment of a Personalized Health Care Intervention for Frequent Headache
Official Title
Assessment of a Personalized Health Care Intervention for Frequent Headache
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frequent Headaches
Keywords
frequent headaches, personalized health plan
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Development of personal health plan
Arm Type
Experimental
Arm Description
Personal Health Plan
Intervention Type
Other
Intervention Name(s)
Personalized health plan
Primary Outcome Measure Information:
Title
Change in Daily headache scores,
Description
Subjects will report daily headache scores to the CRC.
Time Frame
Daily from baseline to 3 months
Title
Change in Quality of life
Time Frame
Baseline to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with chronic headache
Exclusion Criteria:
patients who do not understand english language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Remy Coeytaux, MD
Organizational Affiliation
Duke
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Assessment of a Personalized Health Care Intervention for Frequent Headache
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