Get Going After concussIonN Lite
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Aarhus
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced usual care (EUC)
BehavioralEnhanced 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
BehavioralGAIN 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Control group (EUC)Active comparator 1 intervention
Group B: Intervention Group (EUC + GAIN Lite)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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)
Time frame
6 months: From baseline to 24 weeks after baseline2
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.)
Time frame
6 months: From baseline to 24 weeks after baselineSecondary outcomes
1
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.
Time frame
3 months: From baseline to 12 weeks after baseline (End of treatment)2
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)
Time frame
3 months: From baseline to 12 weeks after baseline (End of treatment)3
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.
Time frame
9 months: From baseline to 36 weeks after baseline4
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)
Time frame
9 months: From baseline to 36 weeks after baselineOther outcomes
1
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).
Time frame
Six months after end of treatment2
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).
Time frame
Six months after end of treatment3
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).
Time frame
Six months after end of treatment4
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
Time frame
Three monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Aarhus
Lead sponsor
Hammel Neurorehabilitation Centre and University Research Clinic
Collaborator
Health Research Foundation of Central Denmark Region
Collaborator
Source ClinicalTrials.gov