Get Going After concussioN 2.0 (GAIN2)

November 10, 2023 updated by: University of Aarhus

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
310

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hammel, Denmark, 8450
        • Regionshospitalet Hammel Neurocenter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Three months after end of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Three months after end of treatment
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.
Three months after end of treatment
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.
Three months after end of treatment
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
Within 12 months after concussion
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
Within 36 months after concussion
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
At 12 months after concussion
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
At 36 months after concussion
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
At 12 months after concussion
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
At 36 months after concussion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hammel Neurorehabilitation Centre and University Research Clinic
Sygeforsikringen danmark
Municipalities in Central Denmark Region

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jørgen F Nielsen, Professor, Hammel Neurorehabilitation Centre and University clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GAIN 2.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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