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OpenTrials
Completed

NCT Number: NCT02177019

Assessment of a Personalized Health Care Intervention for Frequent Headache

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with chronic headache

Exclusion criteria

  • patients who do not understand english language

Treatment and study plan

Personalized health plan

Other

Primary outcomes

  1. Change in Daily headache scores,

    Time frame: Daily from baseline to 3 months

    Subjects will report daily headache scores to the CRC.

  2. Change in Quality of life

    Time frame: Baseline to 3 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 27, 2014
Registry last updated
Jul 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.