Clinical trial NCT05302479: Validating a Modified COMPASS 31questionnaire for Treatment Outcomes
Official title: Validating the Modified COMPASS 31 Questionnaire for Evaluation and Outcomes of Post-concussive Symptoms in Active Duty Military Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Headache, Migraine
Persistent Post Traumatic Headache
Cervicogenic Headache
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: The Defense and Veterans Brain Injury Center
name: The University of Queensland
First posted: 2022-03-31
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present for treatment of headache in the military medical clinic tend to be active duty military patients however retirees and family members will not be excluded from participation.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite Autonomic Symptom Score questionnaire (Compass 31)-Self reported autonomic nervous system symptoms in the past year.
timeFrame: One year
measure: Composite Autonomic Symptom Score questionnaire (Compass 31)- Self reported autonomic nervous system symptoms in the past month (COMPASS 31-month).
timeFrame: One month
measure: Neurobehavioural symptom inventory (NSI) a 22-item self-report questionnaire of neurobehavioral symptoms.
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Brooke Army Medical Centre
state: Texas
Study officials:
affiliation: BAMC-BIRS
name: Matt H Hammerle, DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Howard L, Dumkrieger G, Chong CD, Ross K, Berisha V, Schwedt TJ. Symptoms of Autonomic Dysfunction Among Those With Persistent Posttraumatic Headache Attributed to Mild Traumatic Brain Injury: A Comparison to Migraine and Healthy Controls. Headache. 2018 Oct;58(9):1397-1407. doi: 10.1111/head.13396. Epub 2018 Aug 29.
citation: King PR, Donnelly KT, Donnelly JP, Dunnam M, Warner G, Kittleson CJ, Bradshaw CB, Alt M, Meier ST. Psychometric study of the Neurobehavioral Symptom Inventory. J Rehabil Res Dev. 2012;49(6):879-88. doi: 10.1682/jrrd.2011.03.0051.