NCT04371120

Brief Summary

The purpose of this study is to validate the Brain Injury Self-Efficacy Scale as a measure of self-efficacy in brain injury by comparing it with other measures of self-efficacy, the GSE, and PROMIS self-efficacy.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2019

Completed
9 months until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

4.2 years

First QC Date

August 8, 2019

Last Update Submit

November 20, 2025

Conditions

Keywords

Traumatic Brain InjurySelf EfficacyValidation

Outcome Measures

Primary Outcomes (1)

  • Brain Injury Self-Efficacy Scale (BICS-Q)

    This measures assesses perceived self-efficacy (PSE) regarding a person's brain injury. The scale ranges from 0 (Not at all confident) to 4 (Extremely confident). This measure provides a total score in which higher scores mean greater self-efficacy.

    Baseline

Secondary Outcomes (2)

  • Patient-reported Outcome Measurement Information System (PROMIS): Self-efficacy for managing symptoms

    Baseline

  • The General Self-Efficacy Scale (GSE)

    Baseline

Study Arms (1)

Brain Injury Survivors

Traumatic or acquired brain injury survivors, patients of RHI

Diagnostic Test: BICS Q

Interventions

BICS QDIAGNOSTIC_TEST

assess perceived self-efficacy (PSE) regarding a person's brain injury and proved responsive to treatment effects in the original BICS study.15-16 Specifically, it measures a person's perceptions about his or her ability to both understand the effects of brain injury, as well as, perceived capability of managing BI-related challenges. As the literature suggests, it is important to utilize a measure that would assess PSE specific to the person's challenge, rather than a general PSE scale.

Brain Injury Survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants are survivors of traumatic or acquired brain injury who are coming into RHI for neuropsychological testing.

You may qualify if:

  • persons with a history of brain injury (e.g., Traumatic Brain Injury) or acquired BI such as stroke, hypoxia, ruptured aneurysm, or metabolic encephalopathy)
  • age 18 and older
  • able to speak English fluently.

You may not qualify if:

  • \- present with receptive/expressive aphasia preventing them from comprehending the questions or responding appropriately

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46268, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2019

First Posted

May 1, 2020

Study Start

April 1, 2019

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations