SAFIR© : An Early Intervention for Supporting Families of Patients With Acquired Brain Injuries

NCT04138524 | Terminated DMC

• 1 other identifier: SAFIR©
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the feasibility of a newly developed intervention to improve family support for patient with acquired brain injury (ABI) in early phase of hospitalization (SAFIR): the main components are the assessment of the family, the emotional support for the families, the information giving to the families, the inclusion of the families in the care process and the care coordination between the inter professional team. The main outcomes of the study are feasibility and acceptability outcomes of the newly developed intervention, and trend in efficacy in the family functioning, coping and perceived support from the nurses.

Conditions

Acquired Brain Injury

Keywords

Acquired Brain Injury; Family; Nursing interventions; Stroke; Traumatic Brain Injury; Oncology; caregivers

Outcome Measures

Primary Outcomes (1)

• Fidelity of the SAFIR intervention delivery: fidelity checklist and dashboard.

  Fidelity will be assessed via a fidelity to protocol checklist and a dashboard recording the ability of the CNS to carry out the intervention regarding the context

  6 months

Secondary Outcomes (5)

• Recruitment and Retention rate

  6 months

• Assessing acceptability of the SAFIR intervention: semi-structured interviews

  6 months

• Iceland-Expressive Family Functioning Questionnaire

  Up to 6 months

• Iceland-Perceived Support Questionnaire

  Up to 6 months

• Brief-COPE

  Up to 6 months

Study Arms (1)

interventional

EXPERIMENTAL

All the participants will received the full SAFIR. SAFIR is composed with 5 core components: 1) assessment of the family, 2) emotional support, 3) information, 4) family engagement, 5) care coordination. Each family will participate in 3 structured family meetings, with a follow-up at 30 days. During each meeting, every core component will be delivered but their dose will be adapted following the priorities of the families.

Other: SAFIR©

Interventions

SAFIR© OTHER

Early Supportive intervention for families of patients with acquired brain injuries.

interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Departement of clinical neurosciences-Lausanne University Hospital

Lausanne, Canton of Vaud, 1000, Switzerland

Location

MeSH Terms

Conditions

Brain Injuries; Stroke; Brain Injuries, Traumatic; Neoplasms

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Philippe Ryvlin, PhD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ordinary Professor

Model Details: Feasibility study, no control group

Study Record Dates

• First Submitted: October 5, 2019
• First Posted: October 24, 2019
• Study Start: November 21, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)