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Brain Injury Inpatient Educational Intervention for Families and Caregivers

NCT ID: NCT01062243

Last Updated: 2013-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-09-30

Brief Summary

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The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS) is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute, inpatient brain injury rehabilitation.

Detailed Description

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The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS), developed by J. Niemeier and J. Kreutzer, is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute brain injury rehabilitation. Program development was guided by considerable clinical experience, research review, and solicited consumer feedback.

The intervention has been manualized to facilitate efficient and effective administration. Now, a rigorous investigation involving randomized assignment to treatment and control groups is needed to empirically examine outcomes. Helping family members to cope more effectively has the potential to improve outcomes for persons with ABI. Strengthening families can enable persons with ABI to live more independently, achieve greater community integration, and live healthier lives. The investigation serves as a logical next step forward in advancing our understanding of standardized interventions designed to serve the family unit.

Conditions

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Traumatic Brain Injury Acquired Brain Injury

Keywords

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brain injury family treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Brain Injury Education

The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS), developed by J. Niemeier and J. Kreutzer, is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute brain injury rehabilitation.

Group Type EXPERIMENTAL

Brain Injury Education

Intervention Type BEHAVIORAL

The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS), developed by J. Niemeier and J. Kreutzer, is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute brain injury rehabilitation.

Interventions

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Brain Injury Education

The Brain Injury Inpatient Guide for Families and Caregivers (BIIG-FACS), developed by J. Niemeier and J. Kreutzer, is a comprehensive intervention to meet the needs of family members and significant others of patients who are undergoing acute brain injury rehabilitation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Family members/caregiver friends of patients with ABI will be eligible to participate in the present investigation. ABI is defined as damage to brain tissue caused by stroke, aneurysm, anoxia, non-progressive brain tumor, infection, or an external mechanical force as evidenced by: loss of consciousness, post traumatic amnesia (PTA), objective neurological findings, or skull fracture.
* Lacerations and/or bruises of the scalp or forehead without other criteria listed above will be excluded.
* All family member participants and patients must be at least 18 years of age or older and able to understand and provide consent (or assent in the case of the patients).

Exclusion Criteria

* Family members at imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others, as judged by the investigators, will be excluded from the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey S Kreutzer, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.

Reference Type DERIVED
PMID: 34813082 (View on PubMed)

Niemeier JP, Kreutzer JS, Marwitz JH, Sima AP. A Randomized Controlled Pilot Study of a Manualized Intervention for Caregivers of Patients With Traumatic Brain Injury in Inpatient Rehabilitation. Arch Phys Med Rehabil. 2019 Apr;100(4S):S65-S75. doi: 10.1016/j.apmr.2018.07.422. Epub 2018 Jul 31.

Reference Type DERIVED
PMID: 30075147 (View on PubMed)

Other Identifiers

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H133A070036

Identifier Type: -

Identifier Source: org_study_id