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Get Going After concussIonN Lite (GAIN Lite): A Digital Intervention to Reduce Impairing Post-concussional Mild-to-moderate Symptoms in Adults

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Background: Concussion affects around 25 000 people each year in Denmark. A large research initiative (GAIN 2.0) has been established, and the current study is a part of this initiative.

Aims: 1. To develop and test the efficacy of a novel intervention for people with persistent post-concussional mild-to-moderate symptoms: Get going After concussion Lite (GAIN Lite). 2. To increase the knowledge about the target group by investigating the association of physical activity, digital behaviour, and symptom load.

Methods: A randomized controlled trial, comparing GAIN Lite to enhanced usual care. 100 adults diagnosed with a concussion at hospitals in Central Denmark Region or referred from general practitioners will be recruited. GAIN Lite is a digital intervention, and the primary outcome is the severity of post-concussional symptoms. A prospective cohort study will be performed to investigate the association between physical activity, cognitive processing, and symptom load.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri (26). The criteria are based on recommendations by the WHO Task Force, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out acceleration - deceleration traumas;

• Age 18 to 60 years at the time of the trauma;

• A total score of 10-30 on RPQ within 1 week before enrolment in the study;

• Able to understand, speak and read Danish;

• Living in Central Denmark Region;

• Identified from registers of the emergency departments or referred by GPs to GAIN Lite within 2-4 months after a concussion

Locations
Other Locations
Denmark
Hammel Neurorehabilitation Centre and University Research Clinic
RECRUITING
Hammel
Contact Information
Primary
Sedsel Pedersen, PhD student
sedped@rm.dk
+45 40171098
Backup
Iris Brunner, PhD
iris.brunner@rm.dk
+45 60568195
Time Frame
Start Date: 2023-02-13
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 100
Treatments
Active_comparator: Control group (EUC)
Enhanced usual care (EUC):~All participants will by a health professional be shortly informed about the typical recovery process, the given reassurance about the prognosis.as well as advice on adaptive illness behaviours post-concussion.
Experimental: Intervention Group (EUC + GAIN Lite)
GAIN Lite:~GAIN Lite in an add-on to EUC, and contains two major components: 1) self-administrated e-learning videos and 2) up to four hours video- or phone sessions with an allocated therapist (either an occupational- or a physiotherapist) during a period of 8 weeks. Health professionals provide feedback and guidance, addressing the specific aims and context of the individual.
Related Therapeutic Areas
Sponsors
Collaborators: Hammel Neurorehabilitation Centre and University Research Clinic, Health Research Foundation of Central Denmark Region
Leads: University of Aarhus

This content was sourced from clinicaltrials.gov