Assessment of a Personalized Health Care Intervention for Frequent Headache

NCT ID: NCT02177019

Last Updated: 2015-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-07-31

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.

Conditions

Frequent Headaches

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Development of personal health plan

Personal Health Plan

Group Type: EXPERIMENTAL

Personalized health plan

Intervention Type: OTHER

Interventions

Personalized health plan

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients with chronic headache

Exclusion Criteria

• patients who do not understand english language

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Remy Coeytaux, MD

Role: PRINCIPAL_INVESTIGATOR

Duke

Other Identifiers

1K18HS022443-01

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

Pro00050263

Identifier Type: -

Identifier Source: org_study_id