Acquired Brain InjuryFITSNCT03814876
Family Intervention Following Traumatic Injury
A study testing Group session psycho-education and FITS in people with Acquired Brain Injury and Spinal Cord Injuries, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effectiveness of a manualized intervention (FITS) to families living with brain injury or spinal cord injury. The intervention will be provided by a trained neuropsychologist and consists of 8 structured sessions of 90 minutes duration. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acquired Brain Injury, Spinal Cord Injuries
- What is being tested?
- Group session psycho-education and FITS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2018to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acquired brain injury or spinal cord injury
- Talk and read Danish
- Minimum 6 months to 2 years since discharge
- Family members must be actively involved in the patient's rehabilitation
Who cannot join
- Severe aphasia
- Families, where other family members require a substantial amount of care
- Prior psychiatric or neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Manualized Family Intervention Following Brain Injury or Spinal Cord Injury
The purpose of this study is to investigate the effectiveness of a manualized intervention (FITS) to families living with brain injury or spinal cord injury. The intervention will be provided by a trained neuropsychologist and consists of 8 structured sessions of 90 minutes duration. The intervention group will be compared to a control group receiving treatment as usual, one psycho-educational group session of a 2 hour duration.
- Conditions
- Acquired Brain Injury, Spinal Cord Injuries
- Being tested
- Group session psycho-education, FITS
- Medical subject headings
- Brain Injuries, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group session psycho-educationBehavioural
Active comparator - control group
FITSBehavioural
Manualized family intervention
| Study group | Role | What they receive |
|---|---|---|
| SCI intervention | Experimental | Spinal cord injury intervention group Receives: Behavioral: FITS |
| SCI control | Active comparator | Spinal cord injury control Receives: Behavioral: Group session psycho-education |
| TBI intervention | Experimental | Traumatic brain injury intervention group Receives: Behavioral: FITS |
| TBI control | Active comparator | Traumatic brain injury control group Receives: Behavioral: Group session psycho-education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease specific quality of life
Measured by Qolibri for patients with traumatic brain injury. The QOLIBRI consists of six novel items that assess overall satisfaction with facets of life relevant to people with TBI. Areas covered by the questionnaire include physical condition, cognition, emotions, function in daily life, personal and social life, and current situation and future prospects. Responses to each item are scored 1 ('Not at all') to 5 ('Very'), and the sum of all items was converted arithmetically to a percentage scale, with 0 representing the lowest possible HRQoL on the questionnaire and 100 the best possible HRQoL.
Measured: Change from day 0 to week 8, follow up at six months
Generic quality of life
Short Form-36 (SF-36) completed by all participants. SF-36, a measure of self-reported HRQoL. The questionnaire comprises 36 items addressing eight dimensions of health: vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health. The original summative scoring algorithm will be used, and raw scores will be converted into standard SF-36 scores ranging from 0-100 by calculating the product 100∗(actual sum score / highest possible score), with higher scores indicating better health. The scores will be evaluated according to Danish norms provided by Bjorner, Damsga°rd, Watt, and Bech (1997). This normative study showed high Cronbach's alpha coefficients on all the sub-scales ranging from .75-.85 (Bjorner et al., 1997).
Measured: Change from day 0 to week 8, follow up at six months
Disease specific quality of life
QoL basic data elements for spinal cord injury for patients with spinal cord injury. The QoL Basic Data Set consists of three items on satisfaction with life as a whole, satisfaction with physical health and satisfaction with psychological health during the past 4 weeks. Each item is answered on a 0-10 numerical rating scale with markers 'complete dissatisfaction' and 'complete satisfaction'.
Measured: Change from day 0 to week 8, follow up at six months
Caregiver burden
Caregiver burden questionnaire. The burden of the caregivers will be assessed using the 22-item scale Caregiver Burden (CB). The scale consists of five sub-scales: General Strain, Isolation, Disappointment, Emotional Involvement and Environment. A Total Burden index is given by calculating the mean of all 22 items. Each of the 22-items is scored 1-4 (Not at all, Seldom, Sometimes, Often) and the items cover aspects such as caregiver health, psychological well-being, relationship, social network, physical workload and environmental aspects.
Measured: Change from day 0 to week 8, follow up at six months
Self-perceived burden
Burden perceived by the patient (SPB). The patients' SPB was measured with the Danish version of Self-Perceived Burden Scale (SPBS), which contains 10 items and scores range from 0-50. The 10 items were selected based on one single, general burden factor (Cousineau et al. 2003). Higher scores indicate high SPB. To estimate how severe self-perceived burden did patients feel, SPBS scores can be categorised into four stages: none to little (≤ 19), mild to moderate (20-29),moderate to severe (30-39) and severe (≥40).
Measured: Change from day 0 to week 8, follow up at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start1 Apr 2018
- Primary completion1 Jan 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Victims Fund, The Association of Eastern Founders
- Responsible party
- Principal investigator, Anne Norup, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Pernille Langer Soendergaard, MSc, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814876
- Sponsor's protocol ID
- 2018_0004
- Acronym
- FITS
- Status last verified
- Nov 2023
- First submitted
- 15 Jan 2019
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stevens LF, Lehan T, Duran MAS, Plaza SLO, Arango-Lasprilla JC. Pilot Study of a Newly Developed Intervention for Families Facing Serious Injury. Top Spinal Cord Inj Rehabil. 2016 Winter;22(1):49-59. doi: 10.1310/sci2201-49.
PubMed 29398893Soendergaard PL, Wolffbrandt MM, Biering-Sorensen F, Nordin M, Schow T, Arango-Lasprilla JC, Norup A. A manual-based family intervention for families living with the consequences of traumatic injury to the brain or spinal cord: a study protocol of a randomized controlled trial. Trials. 2019 Nov 27;20(1):646. doi: 10.1186/s13063-019-3794-5.
PubMed 31775831
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Manualized Family Intervention Following Brain Injury or Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03814876
- Acronym / sponsor ID
- FITS / 2018_0004
- Conditions
- Acquired Brain Injury, Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- The Danish Victims Fund, The Association of Eastern Founders
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effectiveness of a manualized intervention (FITS) to families living with brain injury or spinal cord injury. The intervention will be provided by a trained neuropsychologist and consists of 8 structured sessions of 90 minutes duration. The intervention group will be compared to a control group receiving treatment as usual, one psycho-educational group session of a 2 hour duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SCI intervention | Experimental | Behavioral: FITSSpinal cord injury intervention group |
| SCI control | Active comparator | Behavioral: Group session psycho-educationSpinal cord injury control |
| TBI intervention | Experimental | Behavioral: FITSTraumatic brain injury intervention group |
| TBI control | Active comparator | Behavioral: Group session psycho-educationTraumatic brain injury control group |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acquired brain injury or spinal cord injury
- Talk and read Danish
- Minimum 6 months to 2 years since discharge
- Family members must be actively involved in the patient's rehabilitation
Key exclusion criteria (3 listed)
- Severe aphasia
- Families, where other family members require a substantial amount of care
- Prior psychiatric or neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group session psycho-educationActive comparator - control group | Behavioural | SCI control, TBI control |
| FITSManualized family intervention | Behavioural | SCI intervention, TBI intervention |
Primary outcome
Disease specific quality of life
Time frame: Change from day 0 to week 8, follow up at six months
Measured by Qolibri for patients with traumatic brain injury. The QOLIBRI consists of six novel items that assess overall satisfaction with facets of life relevant to people with TBI. Areas covered by the questionnaire include physical condition, cognition, emotions, function in daily life, personal and social life, and current situation and future prospects. Responses to each item are scored 1 ('Not at all') to 5 ('Very'), and the sum of all items was converted arithmetically to a percentage scale, with 0 representing the lowest possible HRQoL on the questionnaire and 100 the best possible HRQoL.
Generic quality of life
Time frame: Change from day 0 to week 8, follow up at six months
Short Form-36 (SF-36) completed by all participants. SF-36, a measure of self-reported HRQoL. The questionnaire comprises 36 items addressing eight dimensions of health: vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health. The original summative scoring algorithm will be used, and raw scores will be converted into standard SF-36 scores ranging from 0-100 by calculating the product 100∗(actual sum score / highest possible score), with higher scores indicating better health. The scores will be evaluated according to Danish norms provided by Bjorner, Damsga°rd, Watt, and Bech (1997). This normative study showed high Cronbach's alpha coefficients on all the sub-scales ranging from .75-.85 (Bjorner et al., 1997).
Disease specific quality of life
Time frame: Change from day 0 to week 8, follow up at six months
QoL basic data elements for spinal cord injury for patients with spinal cord injury. The QoL Basic Data Set consists of three items on satisfaction with life as a whole, satisfaction with physical health and satisfaction with psychological health during the past 4 weeks. Each item is answered on a 0-10 numerical rating scale with markers 'complete dissatisfaction' and 'complete satisfaction'.
Caregiver burden
Time frame: Change from day 0 to week 8, follow up at six months
Caregiver burden questionnaire. The burden of the caregivers will be assessed using the 22-item scale Caregiver Burden (CB). The scale consists of five sub-scales: General Strain, Isolation, Disappointment, Emotional Involvement and Environment. A Total Burden index is given by calculating the mean of all 22 items. Each of the 22-items is scored 1-4 (Not at all, Seldom, Sometimes, Often) and the items cover aspects such as caregiver health, psychological well-being, relationship, social network, physical workload and environmental aspects.
Self-perceived burden
Time frame: Change from day 0 to week 8, follow up at six months
Burden perceived by the patient (SPB). The patients' SPB was measured with the Danish version of Self-Perceived Burden Scale (SPBS), which contains 10 items and scores range from 0-50. The 10 items were selected based on one single, general burden factor (Cousineau et al. 2003). Higher scores indicate high SPB. To estimate how severe self-perceived burden did patients feel, SPBS scores can be categorised into four stages: none to little (≤ 19), mild to moderate (20-29),moderate to severe (30-39) and severe (≥40).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Results publication: PubMed 29398893Stevens LF, Lehan T, Duran MAS, Plaza SLO, Arango-Lasprilla JC. Pilot Study of a Newly Developed Intervention for Families Facing Serious Injury. Top Spinal Cord Inj Rehabil. 2016 Winter;22(1):49-59. doi: 10.1310/sci2201-49.
- Derived from this study: PubMed 31775831Soendergaard PL, Wolffbrandt MM, Biering-Sorensen F, Nordin M, Schow T, Arango-Lasprilla JC, Norup A. A manual-based family intervention for families living with the consequences of traumatic injury to the brain or spinal cord: a study protocol of a randomized controlled trial. Trials. 2019 Nov 27;20(1):646. doi: 10.1186/s13063-019-3794-5.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pernille Langer Soendergaard, MSc study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group session psycho-education and FITS in people with Acquired Brain Injury and Spinal Cord Injuries, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease specific quality of life (time frame: Change from day 0 to week 8, follow up at six months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03814876, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.