Digital Solutions for Concussion
DiSCo
Digital Symptom Mapping and Home-based Biofeedback Treatment for Adults with Persistent Postconcussion Symptoms: a Development and Usability Study
1 other identifier
interventional
23
1 country
1
Brief Summary
The objective of this study is to develop new digital solutions for patients with prolonged postconcussion symptoms, and investigate its usability, feasibility, and safety. The digital solutions consist of a 1) symptom mapping and clinical decision support system, and 2) a research-based system for home-based biofeedback treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2022
CompletedStudy Start
First participant enrolled
November 25, 2022
CompletedFirst Posted
Study publicly available on registry
December 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2024
CompletedSeptember 19, 2024
April 1, 2023
1.3 years
November 2, 2022
September 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Usability of new digital solutions for symptom mapping and home-based biofeedback treatment in patients with PPCS/PTH
\- Description mHealth App Usability Questionnaire scores in the target user group; and Mobile App Rating Scale scores by an independent group of clinicians and researchers
Will be assessed at three different time points: After each usability testing during the iterative development cycles (T1 and T2) and after the home-testing period (T3).
Secondary Outcomes (1)
Feasibility and adherence of new digital solutions
Will be assessed after the home-testing period (T3)
Other Outcomes (1)
Safety of new digital solutions
Will be assessed at three different time points: After each usability testing during the iterative development cycles (T1 and T2) and after the home-testing period (T3).
Study Arms (1)
Digital symptom mapping and biofeedback treatment
EXPERIMENTALInterventions
Digital symptom mapping and biofeedback treatment
Eligibility Criteria
You may qualify if:
- Mild TBI as defined by having sustained a head injury with observed or self-reported alteration of consciousness, amnesia, or other relevant acute symptoms.
- PPCS according to the ICD-10 research criteria and PTH according to International Classification of Headache Disorders 3rd edition (ICHD-3). Operationalized as reporting 3 or more symptoms (including headache) on a moderate or greater intensity level on the RPSQ.
- Proficient in Norwegian language (oral and written)
- Signed informed consent
You may not qualify if:
- Less than three months of experience with smartphones
- Not having access to an iOS or Android smartphone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Olavs Hospital
Trondheim, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2022
First Posted
December 2, 2022
Study Start
November 25, 2022
Primary Completion
March 5, 2024
Study Completion
March 5, 2024
Last Updated
September 19, 2024
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share