Get Going After concussioN 2.0

Mild Traumatic Brain Injury Clinical Trial

— GAIN2  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04798885
• Other study ID #: GAIN 2.0
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 310
• Est. completion date: September 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Intervention

Behavioral:
• GAIN 2.0
1) three structured group sessions of two hours duration performed jointly by a neuropsychologist, an occupational therapist and a physiotherapist. Relatives are also invited. 2) Up to five weekly semi-structured individual sessions of 30 min. duration with an allocated therapist

Locations

Country	Name	City	State
Denmark	Regionshospitalet Hammel Neurocenter	Hammel

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Hammel Neurorehabilitation Centre and University Research Clinic, Municipalities in Central Denmark Region, Sygeforsikringen danmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of at least seven in the sum score on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ)	RPQ is a self-report scale to measure the severity of Post Concussion Symptoms covering physical, cognitive, and emotional symptoms with 16 sub-items and a total sum score (range 0-64, higher score define more severe status)	Three months after end of treatment
Secondary	Sumscore in the dimension 'time spend on daily activities' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P).	Utrecht Scale for Evaluation of Rehabilitation-Participation is a generic measurement that both objectively and subjectively measure participation in Instrumental Activities of Daily Living (IADL) such as work, voluntary work, education, family duties and responsibilities, leisure activities, transportation, communication and social activities in three dimensions. The sumscore in each dimension is converted to a 0-100 metric with higher scores meaning af better outcome.	Three months after end of treatment
Secondary	Sumscore in the dimension 'limitations' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P)	Utrecht Scale for Evaluation of Rehabilitation-Participation is a generic measurement that both objectively and subjectively measure participation in Instrumental Activities of Daily Living (IADL) such as work, voluntary work, education, family duties and responsibilities, leisure activities, transportation, communication and social activities in three dimensions.The sumscore in each dimension is converted to a 0-100 metric with higher scores meaning af better outcome.	Three months after end of treatment
Secondary	Sumscore in the dimension 'satisfaction with participation' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P)	Utrecht Scale for Evaluation of Rehabilitation-Participation is a generic measurement that both objectively and subjectively measure participation in Instrumental Activities of Daily Living (IADL) such as work, voluntary work, education, family duties and responsibilities, leisure activities, transportation, communication and social activities in three dimensions.The sumscore in each dimension is converted to a 0-100 metric with higher scores meaning af better outcome.	Three months after end of treatment
Secondary	Long term sick leave defined as public assistance benefits related to illness in more than three consecutive weeks	Calculated based on weekly public assistance benefits extracted from the DREAM register	Within 12 months after concussion
Secondary	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	Calculated based on weekly public assistance benefits extracted from the DREAM register	Within 36 months after concussion
Secondary	Proportion of employed participants defined as receiving no public assistance benefits except from state education fund grants	Calculated based on weekly public assistance benefits extracted from the DREAM register	At 12 months after concussion
Secondary	Proportion of employed participants defined as receiving no public assistance benefits except from state education fund grants	Calculated based on weekly public assistance benefits extracted from the DREAM register	At 36 months after concussion
Secondary	Degree of job stability based on whether labor market contributions have been paid	Monthly measure extracted from the DREAM register	At 12 months after concussion
Secondary	Degree of job stability based on whether labor market contributions have been paid	Monthly measure extracted from the DREAM register	At 36 months after concussion