Family Intervention Following Traumatic Injury

Not Applicable

Completed

• Conditions: Acquired Brain Injury; Spinal Cord Injuries
• Interventions: Behavioral: FITS; Behavioral: Group session psycho-education

• Registration Number: NCT03814876
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-24
• Primary Completion: 2023-01-01
• Study Completion: 2023-04-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCI intervention	FITS	Spinal cord injury intervention group
SCI control	Group session psycho-education	Spinal cord injury control
TBI intervention	FITS	Traumatic brain injury intervention group
TBI control	Group session psycho-education	Traumatic brain injury control group

Primary Outcome Measures

Name	Time	Method
Generic quality of life	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	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	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	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).

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Hvidovre, Denmark