search
Back to results

Get Going After concussIonN Lite (GAIN Lite)

Primary Purpose

Brain Concussion, Mild Traumatic Brain Injury, Commotio Cerebri

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Enhanced usual care (EUC)
Get Going after concussIoN Lite
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Concussion focused on measuring Brain concussion, Behavior therapy, Early intervention, Mild traumatic brain injury, Post-concussion syndrome, Rivermead post-concussion symptoms questionaire

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Concussion within the last 2-4 months according to the diagnostic criteria recommended by the WHO Task Force
  • Age 18-60 years at the time of the head trauma
  • Moderate symptoms defined as a sum score >9 on the RPQ 2-4 months post-injury
  • Living in Central Denmark Region
  • Able to speak and read Danish

Exclusion Criteria:

  • Objective neurological findings from the neurological examination and/or acute trauma CT scan, indicating neurological disease or brain damage
  • Previous concussion within the last two years, leading to persistent and prolonged PCS (>3 months)
  • Misuse of alcohol, prescription drugs and/or illegal drugs
  • Severe psychiatric morbidity that has required treatment at a hospital or by a practicing psychiatrist i.e., bipolar disorder, autism, psychotic disorder (lifetime) ect.
  • Severe somatic disease that impedes participation in the treatment, i.e., multiple sclerosis, Parkinson's disease etc.
  • Significant learning difficulties or mental retardation

Sites / Locations

  • Hammel Neurorehabilitation Centre and University Research ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group (EUC)

Intervention Group (EUC + GAIN Lite)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rivermead Post-concussion Questionnaire (RPQ/DK)
RPQ/DK is a self-report questionaire 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)
Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P/DK)
USER-P/DK is a self-report questionaire that covers aspects of participation with three separate scales: Frequency, Restrictions and Satisfaction. The restrictions scale will be used. It contains 11 sub-items that are based on whether the participant experience any limitations in daily life. A sum score from 0-100 i created. (A higher score indicates a more favorable level of participation, i.e. fewer restrictions experienced.)

Secondary Outcome Measures

Brief Illness Perception Questionnaire (B-IPQ/DK)
B-IPQ/DK consists of nine self-reported items: Eight items that covers cognitive illness, emotional representations and illness comprehensibility on a 0-to-10 response scale. (Range 0-80, higher score reflects a more negative perception). Item 9 is an open-ended response item, which asks paticipants to list the three most important causal factors in their illness. Responses to the causal item can be grouped into categories and analysed.
Behavioral Response to Illness Questionnaire (BRIQ/DK)
BRIQ/DK is a self-report measure to assess frequency of illness behaviors, and consists of 4 subscales (19 items) on a 0-5 response scale (Range 0-95, higher scores indicate that the participant engaged in the behavior more frequently)
Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P)
TiC-P/DK is a self-report measure designed to assess direct and indirect costs associated with mental health. Part II collects information on respondents' workplace absenteeism and/ or reduction in productivity in paid or unpaid work due to mental health illnesses in the past month.
Work Ability Index Short form (WAI-2)
The WAI/DK describes how capable an employee is of doing his/her job and the questionnaire consists of seven subscales referring to these aspects of work ability: Subscale 1 is used (WAI 1: current work ability compared with lifetime best)

Full Information

First Posted
January 10, 2022
Last Updated
March 16, 2023
Sponsor
University of Aarhus
Collaborators
Hammel Neurorehabilitation Centre and University Research Clinic, Health Research Foundation of Central Denmark Region, Department of Clinical Medicine, Aarhus University
search

1. Study Identification

Unique Protocol Identification Number
NCT05233475
Brief Title
Get Going After concussIonN Lite
Acronym
GAIN Lite
Official Title
Get Going After concussIonN Lite (GAIN Lite): A Digital Intervention to Reduce Impairing Post-concussional Mild-to-moderate Symptoms in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2023 (Actual)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Hammel Neurorehabilitation Centre and University Research Clinic, Health Research Foundation of Central Denmark Region, Department of Clinical Medicine, Aarhus University

4. Oversight

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

5. Study Description

Brief 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: 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). 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.
Detailed Description
Get going After concussIonN Lite (GAIN Lite): An digital intervention to reduce impairing post-concussional mild-to-moderate symptoms in adults Background: Concussion, the mildest form of traumatic brain injury, is an important public health concern, affecting around 25 000 people each year in Denmark. Symptoms are associated with high societal burden due to the long-term impact on labour market attachment and increased health care usage and social welfare benefits. Evidence for effective treatment strategies is scarce, resulting in only weak recommendations for most treatment approaches, as reflected in the recently published National Guidelines for Non-Pharmacological treatment for post-concussion symptoms (PCS). Recently, the effect of a novel intervention "Get going After concussIoN" (GAIN) for people with persistent severe PCS was examined with promising results. Based on GAIN, a large research initiative (GAIN 2.0), has been established, and the present study is a part of this initiative. Aims To develop and test the efficacy of a digital intervention for people with persistent mild-to-moderate PCS: "Get going After concussion Lite" (GAIN Lite). To increase the knowledge about the target group by investigating the association of physical activity, digital behaviour, and symptom load. Primary hypothesis: Participants receiving GAIN Lite will 3 months after end of treatment report statistically and clinically significantly greater reduction of PCS compared to participants receiving enhanced usual care. Methods: The present study is a randomized controlled trial (RCT), comparing GAIN Lite to enhanced usual care. GAIN Lite is characterized as a complex intervention as described by the UK Medical Research Council (MRC) guidelines. Accordingly, GAIN Lite will be developed, feasibility-tested and evaluated before implementation into the RCT. Furthermore, the ADAPT process model outlined by Moore et al. will guide the process. During the RCT, a mixed-methods evaluation will be performed to evaluate the cost-effectiveness of GAIN Lite and to identify prerequisites for clinical implementation. Furthermore, a prospective cohort study will be performed to investigate which features of digital behaviour are related to symptom load and physical activity. The project is conducted in the Central Denmark Region and led by Hammel Neurorehabilitation Centre and University Research Clinic. One hundred people between the age of 18-60 diagnosed with a concussion at public hospitals in the Central Denmark Region will be identified from an administrative hospital register. In addition, participants can be referred to the study by general practitioners. Potential participants will approx. 2 months after the concussion receive a standardised and validated battery of questionnaires measuring PCS and daily functioning. Participants considered likely to meet the inclusion criteria will be invited to further screening for eligibility by a physician. Eligible participants will be randomised by a computer algorithm with predefined concealed random numbers to either 1) Enhanced usual care (EUC) or 2) GAIN Lite added to EUC. EUC consists of short information by a health professionel about the typical recovery process, the given reassurance about the prognosis as well as advice on adaptive illness behaviours post-concussion. GAIN Lite is a digital program that 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. The intervention begins 2-4 months after the onset of the concussion. The primary outcome is PCS measured by Rivermead Postconcussion Questionnaire (RPQ). All participants will complete self-reported measures at baseline, at end of treatment and 3 and 6 months after end of treatment. In a subgroup, an app will monitor digital behaviour on the participants' smartphones for 6 months. During the same period, participants will be frequently asked to rate their PCS. Physical activity will be assessed with thigh-worn accelerometers regarding step counts, sedentary behaviour, and sleep.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Concussion, Mild Traumatic Brain Injury, Commotio Cerebri
Keywords
Brain concussion, Behavior therapy, Early intervention, Mild traumatic brain injury, Post-concussion syndrome, Rivermead post-concussion symptoms questionaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Feasibility study, randomized controlled trial, implementation study and a prospective cohort study.
Masking
Care Provider
Masking Description
Both groups will recieve enhanced usual care. The care providers providing the enhanced usual care, will be blinded to group assignment. As the outcome assessor are the participants when the outcome is participant-reported outcomes, none of the outcome assessors are blinded, as it is impossible to blind the participants to group assignment.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group (EUC)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intervention Group (EUC + GAIN Lite)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced usual care (EUC)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Get Going after concussIoN Lite
Other Intervention Name(s)
GAIN Lite, KORT OG GODT OM HJERNERYSTELSE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rivermead Post-concussion Questionnaire (RPQ/DK)
Description
RPQ/DK is a self-report questionaire 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)
Time Frame
6 months: From baseline to 24 weeks after baseline
Title
Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P/DK)
Description
USER-P/DK is a self-report questionaire that covers aspects of participation with three separate scales: Frequency, Restrictions and Satisfaction. The restrictions scale will be used. It contains 11 sub-items that are based on whether the participant experience any limitations in daily life. A sum score from 0-100 i created. (A higher score indicates a more favorable level of participation, i.e. fewer restrictions experienced.)
Time Frame
6 months: From baseline to 24 weeks after baseline
Secondary Outcome Measure Information:
Title
Brief Illness Perception Questionnaire (B-IPQ/DK)
Description
B-IPQ/DK consists of nine self-reported items: Eight items that covers cognitive illness, emotional representations and illness comprehensibility on a 0-to-10 response scale. (Range 0-80, higher score reflects a more negative perception). Item 9 is an open-ended response item, which asks paticipants to list the three most important causal factors in their illness. Responses to the causal item can be grouped into categories and analysed.
Time Frame
3 months: From baseline to 12 weeks after baseline (End of treatment)
Title
Behavioral Response to Illness Questionnaire (BRIQ/DK)
Description
BRIQ/DK is a self-report measure to assess frequency of illness behaviors, and consists of 4 subscales (19 items) on a 0-5 response scale (Range 0-95, higher scores indicate that the participant engaged in the behavior more frequently)
Time Frame
3 months: From baseline to 12 weeks after baseline (End of treatment)
Title
Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P)
Description
TiC-P/DK is a self-report measure designed to assess direct and indirect costs associated with mental health. Part II collects information on respondents' workplace absenteeism and/ or reduction in productivity in paid or unpaid work due to mental health illnesses in the past month.
Time Frame
9 months: From baseline to 36 weeks after baseline
Title
Work Ability Index Short form (WAI-2)
Description
The WAI/DK describes how capable an employee is of doing his/her job and the questionnaire consists of seven subscales referring to these aspects of work ability: Subscale 1 is used (WAI 1: current work ability compared with lifetime best)
Time Frame
9 months: From baseline to 36 weeks after baseline
Other Pre-specified Outcome Measures:
Title
Number of participants who receive no public assistance benefits (State education fund grants excepted)
Description
Register based data on employment in the Danish Register for Evaluation of Marginalisation (DREAM). This register contains weekly information on social transfer payments for all residents of Denmark (since 1996).
Time Frame
Six months after end of treatment
Title
Number of participants who receive public assistance benefits related to illness in more than three consecutive weeks
Description
Register based data on long term sick leave in the Danish Register for Evaluation of Marginalisation (DREAM). This register contains weekly information on social transfer payments for all residents of Denmark (since 1996).
Time Frame
Six months after end of treatment
Title
The degree of employment (based on whether labor market contributions have been paid)
Description
Register based data job stability in the Danish Register for Evaluation of Marginalisation (DREAM). This register contains weekly information on social transfer payments for all residents of Denmark (since 1996).
Time Frame
Six months after end of treatment
Title
Continuously recording the interaction of 50 participants with their smartphones during a period of 3 months (The smart phone use will be linked to activity level and PCS)
Description
Touchscreen data will be gathered in the background with an app (TapCounter) installed on the participants smart phones (Android users only due to system restrictions). The off-the-shelf data gathering tool available through QuantActions, Lausanne will be used. Raw smartphone taps will be converted into candidate measures for health, such as (i) Tapping speed; (ii) Typing speed; (iii) The speed of entering a passcode; (iv) The speed of finding an App icon on the home screen; (v) The number of interactions
Time Frame
Three months
Title
Continuously collecting seven days of accelerometer-assessed physical activity in 50 participants once a month for three months (The activity level will be linked to PCS and smart phone use)
Description
Physical activity will be assessed with thigh-worn accelerometers (Axivity, Ltd, Newcastle AX3) regarding step counts, sedentary behaviour, and sleep
Time Frame
Once a month for three months
Title
Post-concussion symptoms (PCS) is measures on the Rivermead Post-concussion Questionnaire (RPQ/DK) in 50 participants once a month for three months (PCS will be linked to smart phone use and activity level)
Description
RPQ/DK is a self-report questionaire to measure the severity of PCS covering physical, cognitive, and emotional symptoms with 16 sub-items and a total sum score (range 0-64, higher score define more severe status)
Time Frame
Once a month for three months
Title
Evaluation of the feasibility, acceptability, and tolerability of the intervention will be made during the feasibility phase. Individual, organizational, and structural aspects of clinical implementation will be evaluated at the end of the RCT
Description
Semi-structured interviews will be used to evaluate the experiences of all involved stakeholders (participants, professionals, developers, and management).
Time Frame
Before implemention into the RCT and before implementation into clinical practice

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage linked to the concussion, if performed; Previous concussion within the last 2 years with ongoing PCS at the time of the present concussion Severe misuse of alcohol, prescription drugs and/or illegal drugs Severe psychiatric co-morbidity (e.g. bipolar disorder, autism, psychotic disorder (life time)) or severe neurological disease (e.g. multiple sclerosis) that impedes participation in the programme.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sedsel Pedersen, PhD student
Phone
+45 40171098
Email
sedped@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Iris Brunner, PhD
Phone
+45 60568195
Email
iris.brunner@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sedsel Pedersen, PhD student
Organizational Affiliation
Hammel Neurorehabilitation Centre and University Research Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hammel Neurorehabilitation Centre and University Research Clinic
City
Hammel
State/Province
Deb´nmark
ZIP/Postal Code
8450
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sedsel Pedersen, PhD studuent
Phone
+45 40171098
Email
sedsel@hotmail.com
First Name & Middle Initial & Last Name & Degree
Iris Brunner, PhD
Phone
+45 60568195
Email
iris.brunner@rm.dk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31891145
Citation
Thastum MM, Rask CU, Naess-Schmidt ET, Tuborgh A, Jensen JS, Svendsen SW, Nielsen JF, Schroder A. Novel interdisciplinary intervention, GAIN, vs. enhanced usual care to reduce high levels of post-concussion symptoms in adolescents and young adults 2-6 months post-injury: A randomised trial. EClinicalMedicine. 2019 Dec 16;17:100214. doi: 10.1016/j.eclinm.2019.11.007. eCollection 2019 Dec.
Results Reference
result
PubMed Identifier
35906645
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.
Results Reference
result

Learn more about this trial

Get Going After concussIonN Lite

We'll reach out to this number within 24 hrs