Clinical trial NCT04798885: Get Going After concussioN 2.0
Official title: Interdisciplinary Intervention for Patients With Post-concussion Symptoms 3-6 Months Post-injury (GAIN 2.0). A Stepped Wedge Cluster Randomised Trial: Effect on Symptoms, Participation in Daily Activities, and Labour Market Attachment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Commotio Cerebri
Mild Traumatic Brain Injury
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Sygeforsikringen danmark
name: Hammel Neurorehabilitation Centre and University Research Clinic
name: Municipalities in Central Denmark Region
First posted: 2021-03-15
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study tests the promising results of a previous study (GAIN 1.0) in a larger RCT (GAIN 2.0) which takes place in the municipalities of Central Denmark Region where citizens live their daily lives and whose health- and social care systems support citizens who experience persisting PCS.

Detailed description: Concussion, the mildest form of traumatic brain injury, is an important public health concern. Recent studies estimate that persistent post-concussion symptoms (PCS) are present in almost half of the affected citizens at one year post-injury. Prospective studies have demonstrated that these citizens are at risk of developing long-lasting symptoms which are associated with high societal burden due to long-term impact on labour market attachment and increased use of health care and social benefits. In Denmark, there has in recent years been an increasing awareness on societal impact and personal consequences of PCS. Accordingly, clinicians as well as social workers and therapists in the municipalities point to the gab in knowledge concerning PCS and advocate urgently for evidence-based treatment for these citizens. Recently, the research group behind this application developed a novel early intervention - "Get going After concussIoN" (GAIN 1.0) - for citizens who experience persistent PCS three to six months post-concussion. The intervention was tested in a randomized controlled trial (RCT) with promising results. However, it was delivered in a single hospital setting in which these citizens are normally not cared for. In this study the intention is to test the results of GAIN 1.0 in a larger RCT (GAIN 2.0) which takes place in the municipalities of Central Denmark Region where citizens live their daily lives and whose health- and social care systems support citizens who experience persisting PCS.

Eligibility criteria: Inclusion Criteria:

1. Concussion caused by a head trauma according to the diagnostic criteria recommended by WHO. Participants must be referred to the project within two to four months of injury.
2. Age 18 to 60 years at the time of the trauma
3. A RPQ score ≥20.
4. Able to understand, speak and read Danish.
5. Living in Central Denmark Region.

Exclusion Criteria:

1. Objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage.
2. Previous concussion leading to persistent PCS within the last two years.
3. Severe misuse of alcohol, prescription drugs and/or illegal drugs.
4. Psychiatric morbidity or severe neurological disease that impedes participation in the program, i.e. Bipolar Disorder, autism, psychotic disorder (life time), multiple sclerosis etc.

Primary outcomes:
measure: Change of at least seven in the sum score on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ)
timeFrame: Three months after end of treatment
Secondary outcomes:
measure: Sumscore in the dimension 'time spend on daily activities' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P).
timeFrame: Three months after end of treatment
measure: Sumscore in the dimension 'limitations' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P)
timeFrame: Three months after end of treatment
measure: Sumscore in the dimension 'satisfaction with participation' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P)
timeFrame: Three months after end of treatment
measure: Long term sick leave defined as public assistance benefits related to illness in more than three consecutive weeks
timeFrame: Within 12 months after concussion
measure: Cumulated incidence proportion of participants on long term sick leave defined as receiving public assistance benefits related to illness in more than three consecutive weeks
timeFrame: Within 36 months after concussion
measure: Proportion of employed participants defined as receiving no public assistance benefits except from state education fund grants
timeFrame: At 12 months after concussion
measure: Proportion of employed participants defined as receiving no public assistance benefits except from state education fund grants
timeFrame: At 36 months after concussion
measure: Degree of job stability based on whether labor market contributions have been paid
timeFrame: At 12 months after concussion
measure: Degree of job stability based on whether labor market contributions have been paid
timeFrame: At 36 months after concussion
Other outcomes:
Locations:
city: Hammel
country: Denmark
facility: Regionshospitalet Hammel Neurocenter
Study officials:
affiliation: Hammel Neurorehabilitation Centre and University clinic
name: Jørgen F Nielsen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naess-Schmidt ET, Thastum MM, Stabel HH, Odgaard L, Pedersen AR, Rask CU, Silverberg ND, Schroder A, Nielsen JF. Interdisciplinary intervention (GAIN) for adults with post-concussion symptoms: a study protocol for a stepped-wedge cluster randomised trial. Trials. 2022 Jul 29;23(1):613. doi: 10.1186/s13063-022-06572-7.