Get Going After concussioN 2.0 (GAIN2)

• ClinicalTrials.gov Identifier: NCT04798885
• Recruitment Status: Recruiting
• First Posted: March 15, 2021
• Last Update Posted: October 6, 2021
• Sponsor: University of Aarhus
• Collaborators: Sygeforsikringen danmark; Hammel Neurorehabilitation Centre and University Research Clinic; Municipalities in Central Denmark Region
• Information provided by (Responsible Party): University of Aarhus

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Commotio Cerebri; Mild Traumatic Brain Injury	Behavioral: GAIN 2.0	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 12, 2021
• Estimated Primary Completion Date: February 2023
• Estimated Study Completion Date: March 2023

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Enhanced usual care; Participants will be informed about typical Post Concussion Symptoms and the process of typical recovery as well as given reassurance concerning the prognosis. Advice concerning the use of pain relief medication will also be provided.
Experimental: GAIN 2.0 intervention; An eight-week, interdisciplinary intervention program based on principles from cognitive behavioural therapy (CBT) and gradual return to activities.	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

Outcome Measures

Primary Outcome Measures :

1. Change of at least seven in the sum score on the Rivermead Post-Concussion Symptoms Questionnaire (RPQ) [ Time Frame: Three months after end of treatment ]
   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)

Secondary Outcome Measures :

1. Sumscore in the dimension 'time spend on daily activities' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P). [ Time Frame: Three months after end of treatment ]
   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.
2. Sumscore in the dimension 'limitations' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) [ Time Frame: Three months after end of treatment ]
   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.
3. Sumscore in the dimension 'satisfaction with participation' on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) [ Time Frame: Three months after end of treatment ]
   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.
4. Long term sick leave defined as public assistance benefits related to illness in more than three consecutive weeks [ Time Frame: Within 12 months after concussion ]
   Calculated based on weekly public assistance benefits extracted from the DREAM register
5. 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 [ Time Frame: Within 36 months after concussion ]
   Calculated based on weekly public assistance benefits extracted from the DREAM register
6. Proportion of employed participants defined as receiving no public assistance benefits except from state education fund grants [ Time Frame: At 12 months after concussion ]
   Calculated based on weekly public assistance benefits extracted from the DREAM register
7. Proportion of employed participants defined as receiving no public assistance benefits except from state education fund grants [ Time Frame: At 36 months after concussion ]
   Calculated based on weekly public assistance benefits extracted from the DREAM register
8. Degree of job stability based on whether labor market contributions have been paid [ Time Frame: At 12 months after concussion ]
   Monthly measure extracted from the DREAM register
9. Degree of job stability based on whether labor market contributions have been paid [ Time Frame: At 36 months after concussion ]
   Monthly measure extracted from the DREAM register

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Jørgen F Nielsen, Professor; +45 7841 9043; joerniel@rm.dk

Locations

Denmark

Regionshospitalet Hammel Neurocenter; Recruiting

Hammel, Denmark, 8450

Contact: Jørgen Feldbæk Nielsen, Prof

Sponsors and Collaborators

University of Aarhus

Sygeforsikringen danmark

Hammel Neurorehabilitation Centre and University Research Clinic

Municipalities in Central Denmark Region

Investigators

• Principal Investigator: Jørgen F Nielsen, Professor; Hammel Neurorehabilitation Centre and University clinic

More Information

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT04798885
• Other Study ID Numbers: GAIN 2.0
• First Posted: March 15, 2021
• Last Update Posted: October 6, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating