Assessment of a Personalized Health Care Intervention for Frequent Headache

Not Applicable

Completed

• Conditions: Frequent Headaches
• Interventions: Other: Personalized health plan

• Registration Number: NCT02177019
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-27
• Study Start: 2014-08
• Status Verified: 2015-05
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2015-07-17
• Last Update Posted: 2015-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• patients with chronic headache

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Exclusion Criteria

• patients who do not understand english language

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Development of personal health plan	Personalized health plan	Personal Health Plan

Primary Outcome Measures

Name	Time	Method
Change in Daily headache scores,	Daily from baseline to 3 months	Subjects will report daily headache scores to the CRC.
Change in Quality of life	Baseline to 3 months