Post-Concussion Syndrome, Post-Traumatic Headache
Conditions
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.
Interventions
DEVICEDigital symptom mapping and biofeedback treatment
Digital symptom mapping and biofeedback treatment
Sponsors
St. Olavs Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability of new digital solutions for symptom mapping and home-based biofeedback treatment in patients with PPCS/PTH | 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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and adherence of new digital solutions | Will be assessed after the home-testing period (T3) | * Number of days with logged symptom data during a 4-week home-testing period * Number of biofeedback sessions and mean change in biofeedback scores throughout the testing period |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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). | Description of the frequency and severity of adverse events, serious adverse events and unexpected serious adverse events |
Countries
Norway
Outcome results
None listed