Cohort Study on the Effects of Aging in Acquired Brain Injury Patients (BRAINReADAPT)

A prospective cohort study (questionnaires), with an embedded case control study (neuropsychological assessments) in which the data is gathered within a timeframe of 3 years. A group of 700 patients and a group of 100 healthy volunteers will be participating.

Study Overview

• Status: Enrolling by invitation
• Conditions: Traumatic Brain Injury; Subarachnoid Hemorrhage; Acquired Brain Injury; Cerebrovascular Accident

Detailed Description

In the Netherlands an estimated 650.000 people live with the daily consequences of an Acquired Brain Injury (ABI). A substantial amount of these patients acquired their brain injury (traumatic brain injury, subarachnoid hemorrhage or cerebrovascular accident) at a relatively young age: between 18 and 50 years old. The chain-of-care for ABI aims for recovery in the subacute phase, usually within a period of one year after injury. After an adaptation period, the patients reach a new balance, with stabilization of complaints and reintegration, sometimes with the necessity of modifications. The group of patients who acquired a brain injury at a young age, have to face the effects of aging like decreased cognitive functions, which can cause the participation level to drop. This is called the ABI-effect in the current study. At this moment, insufficient information is available about the functioning of people who suffered ABI multiple years ago and have established a new balance, and now make the transition to an older phase of live.

Primary objective:

Explore the prevalence of the ABI-effect, by mapping the participation level.

Secondary objective:

Substantiate the occurence of the ABI-effect, by mapping cognitive functions of patients and compare these to healthy controls.

Tertiary objective:

Gain insight in the need of care for patients, to enhance regular care after ABI.

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• Netherlands
  • Wijk Aan Zee, Netherlands
    • Revalidatiecentrum Heliomare Wijk aan Zee
  • Overijssel
    • Zwolle, Overijssel, Netherlands, 8025 AB
      • Isala Klinieken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have suffered an acute ABI defined by a traumatic brain injury, stroke or subarachnoid haemorrhage who have been admitted at the UMCG or one of the other participating centers.

Description

Inclusion Criteria:

• Current age range between 50-67 years [Rationale: having an age that enables the patient to experience the effects of aging with a low risk of neurodegenerative disease]
• Able to complete questionnaires independently

Additionally, patients must also meet the following criteria:

• Age of acquiring the ABI ≧ 25 years [Rationale: the brain is supposed to be fully developed at a maximum capacity
• ABI must be ≧ 5 years ago] [Rationale :time period regarded sufficient to have achieved a stable level of cognitive functioning and participation after an ABI]
• ABI diagnosis at hospital admission with abnormalities at the brain-CT or MRI
• Independent regarding Activities of Daily Living
• Not living in a long-term care facility

Exclusion Criteria:

• Psychiatric disease (for which participant is currently treated)
• Accompanying disease with reduced life expectancy
• Neurological disease (including recurrent ABI for patients)
• Language barriers prohibiting and completion of Dutch questionnaires
• Alcohol or drug abuse
• Suspected neurodegenerative disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Acquired Brain Injury Patients; Questionnaire and, if the requirements are met, a neuropsychological assessment.
Healthy volunteers; Questionnaire and, if the requirements are met, a neuropsychological assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of the ABI-effect	The percentage of patients experiencing the ABI-effect. Also, a 95% confidence interval of this prevalence will be calculated.	A minimum of 5 years after ABI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive functions of patients and healthy volunteers	The significant difference in cognitive functions between the patient groep and the healthy controls	A minimum of 5 years after ABI for patients

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Stroke; Brain Injuries; Wounds and Injuries; Hemorrhage; Brain Injuries, Traumatic; Subarachnoid Hemorrhage
• Other Study ID Numbers: NL79072.042.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No