Validating a Modified COMPASS 31questionnaire for Treatment Outcomes

NCT05302479 | Unknown

• 1 other identifier: C.2021.128e
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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. 1.Compare results for the COMPASS 31(year) to the modified COMPASS 31(month) at baseline.
2. 2.Compare modified COMPASS 31(month) to the NSI at baseline and post intervention.

Conditions

Headache, Migraine; Persistent Post Traumatic Headache; Cervicogenic Headache

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

COMPASS 31 questionnaire OTHER

A 31 question questionnaire that measures autonomic symptoms.

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Normal composite autonomic symptom score.

Sponsors & Collaborators

• Brooke Army Medical Center: lead
• The Defense and Veterans Brain Injury Center: collaborator
• The University of Queensland: collaborator

Study Sites (1)

Brooke Army Medical Centre

Houston, Texas, 78234, United States

RECRUITING

Related 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.

  PMID: 30156267 BACKGROUND

• 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.

  PMID: 23299259 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Secondary

Study Officials

• Matt H Hammerle, DPT

  BAMC-BIRS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matt H Hammerle, DPT

CONTACT

210-916-8693; matt.h.hammerle.civ@mail.mil

Lisa H Lu, PhD

CONTACT

210-916-6029; lisa.h.lu.ctr@mail.mil

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Physical Therapy

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 31, 2022
• Study Start: April 15, 2022
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)