Get Going After concussIonN Lite

Mild Traumatic Brain Injury Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05233475
• Other study ID #: 100276
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: February 2023
• Source: University of Aarhus
• Contact: Sedsel Pedersen, PhD student
• Phone: +45 40171098
• Email: sedped[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

1. 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).

2. 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.

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

1. 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).

2. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2026
• 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 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;

2. Age 18 to 60 years at the time of the trauma;

3. A total score of 10-30 on RPQ within 1 week before enrolment in the study;

4. Able to understand, speak and read Danish;

5. Living in Central Denmark Region;

6. Identified from registers of the emergency departments or referred by GPs to GAIN Lite within 2-4 months after a concussion

Exclusion Criteria:

1. Objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage linked to the concussion, if performed;

2. Previous concussion within the last 2 years with ongoing PCS at the time of the present concussion

3. Severe misuse of alcohol, prescription drugs and/or illegal drugs

4. 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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Enhanced usual care (EUC)
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.
• Get Going after concussIoN Lite
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.

Locations

Country	Name	City	State
Denmark	Hammel Neurorehabilitation Centre and University Research Clinic	Hammel	Deb´nmark

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Department of Clinical Medicine, Aarhus University, Hammel Neurorehabilitation Centre and University Research Clinic, Health Research Foundation of Central Denmark Region

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. — View 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 mon — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants who receive no public assistance benefits (State education fund grants excepted)	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).	Six months after end of treatment
Other	Number of participants who receive public assistance benefits related to illness in more than three consecutive weeks	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).	Six months after end of treatment
Other	The degree of employment (based on whether labor market contributions have been paid)	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).	Six months after end of treatment
Other	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)	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	Three months
Other	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)	Physical activity will be assessed with thigh-worn accelerometers (Axivity, Ltd, Newcastle AX3) regarding step counts, sedentary behaviour, and sleep	Once a month for three months
Other	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)	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)	Once a month for three months
Other	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	Semi-structured interviews will be used to evaluate the experiences of all involved stakeholders (participants, professionals, developers, and management).	Before implemention into the RCT and before implementation into clinical practice
Primary	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)	6 months: From baseline to 24 weeks after baseline
Primary	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.)	6 months: From baseline to 24 weeks after baseline
Secondary	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.	3 months: From baseline to 12 weeks after baseline (End of treatment)
Secondary	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)	3 months: From baseline to 12 weeks after baseline (End of treatment)
Secondary	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.	9 months: From baseline to 36 weeks after baseline
Secondary	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)	9 months: From baseline to 36 weeks after baseline