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Assessment of a Personalized Health Care Intervention for Frequent Headache

Assessment of a Personalized Health Care Intervention for Frequent Headache

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02177019
Enrollment
31
Registered
2014-06-27
Start date
2014-08-31
Completion date
2015-07-31
Last updated
2015-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frequent Headaches

Keywords

frequent headaches, personalized health plan

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.

Interventions

OTHERPersonalized health plan

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients with chronic headache

Exclusion criteria

* patients who do not understand english language

Design outcomes

Primary

MeasureTime frameDescription
Change in Daily headache scores,Daily from baseline to 3 monthsSubjects will report daily headache scores to the CRC.
Change in Quality of lifeBaseline to 3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026