Traumatic Brain Injury; Needs and Treatment Options in the Chronic Phase

NCT03545594 | Completed

• 1 other identifier: TBIcommunity
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Traumatic brain injury (TBI) is a condition affecting the persons' central nervous system with a need for extensive and highly specialized initial health care provision followed by comprehensive rehabilitation efforts. Frequent and life-long medical, cognitive, emotional and behavioral changes are expected. The community-based services are largely responsible for dealing with the chronic challenges affecting people with TBI. 120 patients \>16 years at the time of injury and between 18 and 72 years at inclusion, with clinical TBI diagnosis on acute admission and verified injury-related intracranial abnormalities reporting cognitive, emotional and physical problems more than 2 years after the injury will be included and randomized to a patient-centered in-home program intervention and treatment as usual. The intervention consists of an individualized and goal-oriented intervention will be provided in the persons' home environment, in close collaboration with family members and local health care providers when available. Assessments will be conducted at baseline, at the end of the intervention 4 months after inclusion and one year after inclusion. Primary outcome is participation (Part-O) and TBI specific health related quality of life (Qolibri). Secondary outcomes include goal attainment within individualized targeted outcome areas, depression and anxiety, symptom burden, unmet health care needs and acceptability of intervention as assessed by patient, family member and health professional. The project will contribute to increased understanding of knowledge transfer processes, and dissemination of evidence based practice for TBI. Thus, the project has the potential to improve the current health care for patients with TBI and its delivery.

Conditions

Traumatic Brain Injury

Keywords

Randomized trial,; Health care needs; Traumatic brain injury; Community; Goal attainment

Outcome Measures

Primary Outcomes (2)

• Participation

  Participation assessment and Recombined Tools- Objective (PART-O) (Social domain)

  12 months

• General Health

  Quality of Life after Brain Injury (Qolibri overall scale, sum score of 6 items )

  12 months

Secondary Outcomes (12)

• Global functioning

  4 and 12 months

• Depression

  4 months (patients and family) and 12 months intervention (patients)

• Physical and mental health (EQ-5D) and quality-adjusted life years, (QALYs)

  4 and 12 months

• Acceptability and satisfaction with the intervention

  4 and 12 months

• Target outcome areas

  4 and 12 months

Study Arms (2)

Patient-centered in home rehabilitation

EXPERIMENTAL

Eight contacts of about 2 hours duration each delivered over a 4-month period (Six in home visits and two telephone contacts before the Corona pandemic and adjusted to eight contacts and up to six of them video based when necessary during the Corona pandemic) in three phases:

Other: Patient-centered in home rehabilitation

Control

ACTIVE COMPARATOR

Usual follow-up assessment and health care and rehabilitation services provided in the municipality

Other: Control

Interventions

Patient-centered in home rehabilitation OTHER

Eight contacts (six in-home visits of 1-2 hours duration each and two telephone contacts before the Corona pandemic and eight sessions with up to six of them video delivered if necessary during the Corona pandemic ) delivered over a 4-month period in three phases

Patient-centered in home rehabilitation

Control OTHER

Usual follow-up in the municipality

Control

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients reporting TBI-related cognitive, emotional and physical problems and/or reduced physical and mental health and/or difficulties with participation in activities with family, friends and in the community at least 2 years after the injury,
• Able to provide informed consent and collaborate in the goal setting processing.

You may not qualify if:

• Patients are excluded if they have severe preexisting neurological disorder that would confound outcome assessments and severe psychiatric diseases
• Patients unable to provide informed consent or participate in a goal-setting process.
• Participants with insufficient fluency in Norwegian to allow for communication with therapists and outcome assessors will also be excluded.
• Substance abuce or history of violence that could represent a security risk for the professionals delivering the intervention

Sponsors & Collaborators

• Oslo University Hospital: lead
• Sunnaas Rehabilitation Hospital: collaborator
• Virginia Commonwealth University: collaborator

Study Sites (1)

OUH

Oslo, 0407, Norway

Location

Related Publications (4)

• Lovstad M, Borgen IMH, Hauger SL, Kleffelgard I, Brunborg C, Roe C, Soberg HL, Forslund MV. Family member reported symptom burden, predictors of caregiver burden and treatment effects in a goal-oriented community-based randomized controlled trial in the chronic phase of traumatic brain injury. BMC Neurol. 2024 Sep 10;24(1):333. doi: 10.1186/s12883-024-03841-7.

  PMID: 39256658 DERIVED

• Kleffelgard I, Forslund M, Hauger S, Roe C, Bragstad LK, Soberg HL, Lovstad M, Borgen IMH. Process evaluation of a complex intervention evaluating the effectiveness of home-based rehabilitation in the chronic phase of traumatic brain injury. Disabil Rehabil. 2024 Dec;46(25):6134-6142. doi: 10.1080/09638288.2024.2324119. Epub 2024 Mar 6.

  PMID: 38445314 DERIVED

• Borgen IMH, Lovstad M, Hauger SL, Forslund MV, Kleffelgard I, Andelic N, Sveen U, Soberg HL, Sigurdardottir S, Winter L, Lindstad MO, Brunborg C, Roe C. Effect of an Individually Tailored and Home-Based Intervention in the Chronic Phase of Traumatic Brain Injury: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2310821. doi: 10.1001/jamanetworkopen.2023.10821.

  PMID: 37145600 DERIVED

• Borgen IMH, Lovstad M, Andelic N, Hauger S, Sigurdardottir S, Soberg HL, Sveen U, Forslund MV, Kleffelgard I, Lindstad MO, Winter L, Roe C. Traumatic brain injury-needs and treatment options in the chronic phase: Study protocol for a randomized controlled community-based intervention. Trials. 2020 Mar 27;21(1):294. doi: 10.1186/s13063-020-4195-5.

  PMID: 32216840 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Cecilie Røe

  OUH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent Outcome Assessor(s) blinded to the intervention arm by masking the ID and randomization arm on the assessment and outcome forms.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 4, 2018
• Study Start: June 1, 2018
• Primary Completion: April 30, 2021
• Study Completion: December 31, 2021
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)