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Validating a Modified COMPASS 31questionnaire for Treatment Outcomes

Validating the Modified COMPASS 31 Questionnaire for Evaluation and Outcomes of Post-concussive Symptoms in Active Duty Military Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05302479
Acronym
COMPASS
Enrollment
35
Registered
2022-03-31
Start date
2022-04-15
Completion date
2023-09-20
Last updated
2022-07-21

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

Conditions

Cervicogenic Headache, Headache, Migraine, Persistent Post Traumatic Headache

Brief summary

Eligible participants will complete the COMPASS 31 (year), modified COMPASS 31(one month) and the NSI (one month) questionnaires at baseline and complete the modified COMPASS 31 and the NSI after usual care of treatment. The investigators will 1. Compare results for the COMPASS 31(year) to the modified COMPASS 31(month) at baseline. 2. Compare modified COMPASS 31(month) to the NSI at baseline and post intervention.

Detailed description

The Composite Autonomic Symptom Score (COMPASS 31) is a validated questionnaire designed to measure self reported autonomic symptoms in the last year in individuals with migraine and post-concussive symptoms. In order to use this questionnaire to measure response to treatment it would be preferable to determine if the results of the COMPASS 31 are similar if the patient is asked to complete this thinking about symptoms in the last year as per the usual questionnaire, compared to a modified COMPASS 31 where symptoms in the past month will be assessed. This prospective trial will compare results of the COMPASS 31 (year) to the modified COMPASS 31 (month). Since the present gold standard for outcome measures in post-concussive treatment is the neurobehavioral symptom inventory (NSI), this study will also compare results of the modified COMPASS 31(month) to the NSI outcome measure at baseline and post treatment to validate the utilization of the modified version of the COMPASS 31(month) for use in the post-concussive population as an outcome measure for self-reported autonomic nervous system symptoms.

Interventions

OTHERCOMPASS 31 questionnaire

A 31 question questionnaire that measures autonomic symptoms.

Sponsors

The Defense and Veterans Brain Injury Center
CollaboratorFED
The University of Queensland
CollaboratorOTHER
Brooke Army Medical Center
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* Patients who present to the BAMC\_BIRS clinic for treatment of headache between the ages of 18-64.

Exclusion criteria

* Normal composite autonomic symptom score.

Design outcomes

Primary

MeasureTime frameDescription
Composite Autonomic Symptom Score questionnaire (Compass 31)-Self reported autonomic nervous system symptoms in the past year.One yearSelf reported autonomic nervous system symptoms in the past year will be measured using the validated, refined and abbreviated Composite Autonomic Symptom Score questionnaire (Compass 31). Scoring ranges from 0-100 with higher scores indicating more autonomic symptoms.
Composite Autonomic Symptom Score questionnaire (Compass 31)- Self reported autonomic nervous system symptoms in the past month (COMPASS 31-month).One monthSelf reported autonomic nervous system symptoms in the past month will be measured using the validated, refined and abbreviated Composite Autonomic Symptom Score questionnaire (Compass 31-month). Scoring ranges from 0-100 with higher scores indicating more autonomic symptoms.
Neurobehavioural symptom inventory (NSI) a 22-item self-report questionnaire of neurobehavioral symptoms.One monthNeurobehavioural symptom inventory (NSI) a 22-item self-report questionnaire of neurobehavioral symptoms. Scores range from 0-88 with higher scores indicating more symptoms.

Countries

United States

Contacts

Primary ContactMatt H Hammerle, DPT
matt.h.hammerle.civ@mail.mil210-916-8693
Backup ContactLisa H Lu, PhD
lisa.h.lu.ctr@mail.mil210-916-6029

Outcome results

None listed

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