GAIN Lite: Get Going After concussIonN Lite
Study Details
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:
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To develop and test the efficacy of a novel intervention for people with persistent post-concussional moderate symptoms: "Get going After concussion Lite" (GAIN Lite).
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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 brief interdisciplinary 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Get going After concussIonN Lite (GAIN Lite): An early intervention to reduce impairing post-concussional 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 current study is a part of this initiative.
Aims
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To develop and test the efficacy of a brief, low-cost, and implementable intervention for people with persistent moderate PCS: "Get going After concussion Lite" (GAIN Lite).
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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 6 months after randomisation report statistically and clinically significantly greater reduction of PCS compared to participants receiving enhanced usual care.
Methods The current 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. During the RCT, an ongoing 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, physical activity, and health-related quality of life. The project is conducted in the Central Denmark Region and led by Hammel Neurorehabilitation Centre and University Research Clinic. One hundred people over the age of 18 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 information by a physician about typical PCS, the typical recovery process, the given reassurance about the prognosis. as well as advice about the use of painkillers provided. GAIN Lite is a bio-psycho-social interdisciplinary intervention that consists of one face-to-face meeting where participants and (if wanted) their closest relative will receive information about PCS, reassurance on the usually benign course, and advice on adaptive symptom management. This approach will be followed up by up to five individual video- or phone sessions over a period of 6 months. 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 and 3 and 6 months after randomization. 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 health-related quality of life. Physical activity will be assessed with thigh-worn accelerometers regarding step counts, sedentary behaviour, and sleep.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Control group (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. |
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.
|
| Experimental: Intervention Group (EUC + GAIN Lite) GAIN Lite: GAIN Lite in an add-on to EUC, and consists of one face-to-face group meeting where participants and (if wanted) their closest relative will receive extended information about post-concussion symptoms, reassurance on the usually benign course, and advice on adaptive symptom management such as gradually resuming premorbid activities and avoiding excessive rest and 'all-or-nothing' behaviour. This education will be followed up by up to three individual video- or phone sessions over a period of 2 months. Health professionals provide feedback and guidance, addressing the specific aims and context of the individual. |
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.
Behavioral: Get Going after concussIoN Lite (GAIN Lite)
GAIN Lite:
GAIN Lite in an add-on to EUC, and consists of one face-to-face group meeting where participants and (if wanted) their closest relative will receive extended information about post-concussion symptoms, reassurance on the usually benign course, and advice on adaptive symptom management such as gradually resuming premorbid activities and avoiding excessive rest and 'all-or-nothing' behaviour. This education will be followed up by up to three individual video- or phone sessions over a period of 2 months. Health professionals provide feedback and guidance, addressing the specific aims and context of the individual.
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in post-concussion symptoms (PCS) on the Rivermead Post-concussion Questionnaire (RPQ/DK) 3 months after end of treatment [Baseline and 3 months after end of treatment]
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)
Secondary Outcome Measures
- Change from baseline in participation in Instrumental Activities of Daily Living on the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P/DK) 3 months after end of treatment [Baseline and three months after end of treatment]
USER-P/DK is a self-report questionaire that covers aspects of participation with three separate scales: Frequency, Restrictions and Satisfaction. The sum scores of the Frequency, Restrictions, and Satisfaction scales are based on the items that are applicable to the person's situation and each sum score is converted to a 0-100 scale (A higher score indicates a more favorable level of participation, i.e. fewer restrictions experienced.)
- Change from baseline in illness perception on the Brief Illness Perception Questionnaire (B-IPQ/DK) 3 months after end of treatment [Baseline and three months after end of treatment]
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.
- Change from baseline in illness behaviour on the Behavioral Response to Illness Questionnaire (BRIQ/DK) three months after end of treatment [Baseline and three months after end of treatment]
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)
Other Outcome Measures
- Number of participants who receive no public assistance benefits (State education fund grants excepted) [Six months after end of treatment]
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).
- Number of participants who receive public assistance benefits related to illness in more than three consecutive weeks [Six months after end of treatment]
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).
- The degree of employment (based on whether labor market contributions have been paid) [Six months after end of treatment]
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).
- 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 quality of life) [Three months]
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
- 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 quality of life and smart phone use) [Once a month for three months]
Physical activity will be assessed with thigh-worn accelerometers (Axivity, Ltd, Newcastle AX3) regarding step counts, sedentary behaviour, and sleep
- Health-related Quality of Life is measured on the Short Form 36 Health Survey (2nd version) (SF-36v2/DK) in 50 participants once a month for three months (The Health-related Quality of Life will be linked to smart phone use and activity level) [Once a month for three months]
The SF-36v2/DK is a self-report questionnaire that assesses eight different aspects of health-related quality of life. For each dimension item scores are coded, summed, and transformed on to a scale from 0 (worst possible health state measured by the questionnaire) to 100 (best possible health state). Two standardized summary scores can also be calculated from the SF-36; the physical component summary (PCS) and the mental health component summary (MCS)
- 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 [Before implemention into the RCT and before implementation into clinical practice]
Semi-structured interviews will be used to evaluate the experiences of all involved stakeholders (participants, professionals, developers, and management).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Concussion within the last 2-4 months according to the diagnostic criteria recommended by the WHO Task Force
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Age 18-60 years at the time of the head trauma
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Moderate symptoms defined as a sum score >9 on the RPQ 2-4 months post-injury
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Living in Central Denmark Region
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Able to speak and read Danish
Exclusion Criteria:
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Objective neurological findings from the neurological examination and/or acute trauma CT scan, indicating neurological disease or brain damage
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Previous concussion within the last two years, leading to persistent and prolonged PCS (>3 months)
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Misuse of alcohol, prescription drugs and/or illegal drugs
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Severe psychiatric morbidity that has required treatment at a hospital or by a practicing psychiatrist i.e., bipolar disorder, autism, psychotic disorder (lifetime) ect.
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Severe somatic disease that impedes participation in the treatment, i.e., multiple sclerosis, Parkinson's disease etc.
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Significant learning difficulties or mental retardation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hammel Neurorehabilitation Centre and University Research Clinic | Hammel | Deb´nmark | Denmark | 8450 |
Sponsors and Collaborators
- University of Aarhus
- Hammel Neurorehabilitation Centre and University Research Clinic
- Health Research Foundation of Central Denmark Region
- Department of Clinical Medicine, Aarhus University
Investigators
- Principal Investigator: Sedsel Pedersen, PhD student, Hammel Neurorehabilitation Centre and University Research Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 100276