search
Back to results

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
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frequent Headaches focused on measuring frequent headaches, personalized health plan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 26, 2014
    Last Updated
    July 17, 2015
    Sponsor
    Duke University
    search

    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

    We'll reach out to this number within 24 hrs