Validating a Modified COMPASS 31questionnaire for Treatment Outcomes

Cervicogenic Headache Clinical Trial

— COMPASS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05302479
• Other study ID #: C.2021.128e
• Status: Recruiting
• Start date: April 15, 2022
• Est. completion date: September 20, 2023

Study information

• Verified date: July 2022
• Source: Brooke Army Medical Center
• Contact: Matt H Hammerle, DPT
• Phone: 210-916-8693
• Email: matt.h.hammerle.civ[@]mail.mil
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: September 20, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervicogenic Headache
• Headache
• Headache, Migraine
• Migraine Disorders
• Persistent Post Traumatic Headache
• Post-Traumatic Headache

Intervention

Other:
• COMPASS 31 questionnaire
A 31 question questionnaire that measures autonomic symptoms.

Locations

Country	Name	City	State
United States	Brooke Army Medical Centre	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Brooke Army Medical Center	The Defense and Veterans Brain Injury Center, The University of Queensland

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Autonomic Symptom Score questionnaire (Compass 31)-Self reported autonomic nervous system symptoms in the past year.	Self 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.	One year
Primary	Composite Autonomic Symptom Score questionnaire (Compass 31)- Self reported autonomic nervous system symptoms in the past month (COMPASS 31-month).	Self 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.	One month
Primary	Neurobehavioural symptom inventory (NSI) a 22-item self-report questionnaire of neurobehavioral symptoms.	Neurobehavioural symptom inventory (NSI) a 22-item self-report questionnaire of neurobehavioral symptoms. Scores range from 0-88 with higher scores indicating more symptoms.	One month