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Clinical Trials/NCT04794894
NCT04794894
Enrolling By Invitation
Not Applicable

Wellness and Quality of Life Perceptions of People With Traumatic Brain Injury Receiving Post-acute Telerehabilitation Versus Clinic-based Services

Quality Living, Inc.1 site in 1 country50 target enrollmentApril 16, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Injuries, Traumatic
Sponsor
Quality Living, Inc.
Enrollment
50
Locations
1
Primary Endpoint
Generalized Anxiety Disorder Screener - 7
Status
Enrolling By Invitation
Last Updated
last year

Overview

Brief Summary

Telerehabilitation is a service delivery method that has grown substantially in recent years. It has both advantages and disadvantages in comparison to clinic-based services. For example, telerehabilitation is advantageous for people residing in locations in which specialized rehabilitation services are scarce; however, it has the disadvantage of being dependent on reliable internet connections that are not available in all locations. Also, some people prefer the privacy afforded by receiving treatment in their home, but other people prefer the interaction with other clients with similar challenges afforded by attending sessions in clinic-based settings. Other questions about advantages and disadvantages of telerehabilitation remain unexplored. One such question is the focus of this research and concerns the effect of receiving post-acute telerehabilitation services versus clinic-based services on the general well-being and quality of life experienced by people with traumatic brain injury. The study purpose is to compare changes in wellness and quality of life occurring over a four-month period during which people with traumatic brain injury receive post-acute services either via telerehabilitation or at an outpatient facility.

Registry
clinicaltrials.gov
Start Date
April 16, 2021
End Date
April 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Sustained traumatic brain injury
  • Receiving inpatient services at Quality Living, Inc., Omaha, NE
  • Fluent in English
  • Scheduled to receive either telerehabilitation or clinic-based rehabilitation services after discharge from Quality Living, Inc.

Exclusion Criteria

  • Receiving services on a scholarship basis from Quality Living, Inc., Omaha, NE
  • Scheduled to receive a combination of telerehabilitation and clinic-based services after discharge from Quality Living, Inc.

Outcomes

Primary Outcomes

Generalized Anxiety Disorder Screener - 7

Time Frame: Change from baseline at 4 months

7-item self-report instrument designed to screen for symptoms and severity of generalized anxiety in adults.

Quality of Life after Brain Injury

Time Frame: Change from baseline at 4 months

37-item questionnaire designed to measure six health-related quality of life dimensions for people with TBI

Beck Depression Inventory - II

Time Frame: Change from baseline at 4 months

21-item self-report instrument on which people rate their experience with depression symptoms within the past two weeks.

Changes in Outlook - Short

Time Frame: Change from baseline at 4 months

10-item self-report instrument assessing both positive and negative reactions to adversity and traumatic experiences.

Secondary Outcomes

  • Telerehabilitation or Clinic-based Post-acute Treatment Survey(4 months after study enrollment)

Study Sites (1)

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