Family Intervention Following Traumatic Injury

Spinal Cord Injuries Clinical Trial

— FITS  

Official title:

Effect of a Manualized Family Intervention Following Brain Injury or Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03814876
• Other study ID #: 2018_0004
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: April 1, 2023

Study information

• Verified date: November 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The intervention group will be compared to a control group receiving treatment as usual, one psycho-educational group session of a 2 hour duration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: April 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Severe aphasia
• Families, where other family members require a substantial amount of care
• Prior psychiatric or neurological disease

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Behavioral:
• Group session psycho-education
Active comparator - control group
• FITS
Manualized family intervention

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Hvidovre

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	The Association of Eastern Founders, The Danish Victims Fund

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from day 0 to week 8, follow up at six months
Primary	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).	Change from day 0 to week 8, follow up at six months
Primary	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'.	Change from day 0 to week 8, follow up at six months
Primary	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.	Change from day 0 to week 8, follow up at six months
Primary	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).	Change from day 0 to week 8, follow up at six months