Validating a Modified COMPASS 31questionnaire for Treatment Outcomes (COMPASS)

July 19, 2022 updated by: Matt Hammerle, Brooke Army Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Autonomic Symptom Score questionnaire (Compass 31)-Self reported autonomic nervous system symptoms in the past year.
Time Frame: One 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
Composite Autonomic Symptom Score questionnaire (Compass 31)- Self reported autonomic nervous system symptoms in the past month (COMPASS 31-month).
Time Frame: One 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
Neurobehavioural symptom inventory (NSI) a 22-item self-report questionnaire of neurobehavioral symptoms.
Time Frame: One month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooke Army Medical Center

Collaborators

The University of Queensland
The Defense and Veterans Brain Injury Center

Investigators

  • Principal Investigator: Matt H Hammerle, DPT, BAMC-BIRS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2022

Primary Completion (Anticipated)

September 20, 2023

Study Completion (Anticipated)

September 20, 2023

Study Registration Dates

First Submitted

February 23, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

July 21, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.2021.128e

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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