Digital Symptom Mapping and Home-based Biofeedback Treatment for Adults With Persistent Postconcussion Symptoms: a Development and Usability Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Post-Concussion Syndrome
- Sponsor
- St. Olavs Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Usability of new digital solutions for symptom mapping and home-based biofeedback treatment in patients with PPCS/PTH
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 or older at the time of inclusion.
- •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
Exclusion Criteria
- •Serious psychiatric or somatic disease, or other patient-related factors, that based on an evaluation of the study personnel responsible for inclusion, will provide obvious challenges for adhering to the protocol, including using the devices.
- •Less than three months of experience with smartphones
- •Not having access to an iOS or Android smartphone
Outcomes
Primary Outcomes
Usability of new digital solutions for symptom mapping and home-based biofeedback treatment in patients with PPCS/PTH
Time Frame: 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).
- 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
Secondary Outcomes
- Feasibility and adherence of new digital solutions(Will be assessed after the home-testing period (T3))