Family Intervention Following Traumatic Injury

NCT03814876 | Completed DMC

• 1 other identifier: 2018_0004
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury; Spinal Cord Injuries

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (4)

SCI intervention

EXPERIMENTAL

Spinal cord injury intervention group

Behavioral: FITS

SCI control

ACTIVE COMPARATOR

Spinal cord injury control

Behavioral: Group session psycho-education

TBI intervention

EXPERIMENTAL

Traumatic brain injury intervention group

Behavioral: FITS

TBI control

ACTIVE COMPARATOR

Traumatic brain injury control group

Behavioral: Group session psycho-education

Interventions

Group session psycho-education BEHAVIORAL

Active comparator - control group

SCI control; TBI control

FITS BEHAVIORAL

Manualized family intervention

SCI intervention; TBI intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• The Danish Victims Fund: collaborator
• The Association of Eastern Founders: collaborator

Study Sites (1)

Rigshospitalet

Hvidovre, 2650, Denmark

Location

Related Publications (2)

• 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.

  PMID: 29398893 RESULT

• Soendergaard 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.

  PMID: 31775831 DERIVED

MeSH Terms

Conditions

Brain Injuries; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases

Study Officials

• Pernille Langer Soendergaard, MSc

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, neuropsychologist

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 24, 2019
• Study Start: April 1, 2018
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

DK (1)