Wellness and Quality of Life Perceptions of People With Traumatic Brain Injury

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Brain Injuries, Traumatic
• Intervention / Treatment: Behavioral: outpatient rehabilitation

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68104
      • Quality Living, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Fifty adults with traumatic brain injury will comprise the participant sample. Prospective participants will be from a convenience sample of people with traumatic brain injury nearing discharge from Quality Living's inpatient program. Participants will form two subgroups-those whose prospective outpatient treatment will be through clinic-based services from practitioners near their home and those whose continued rehabilitation will be through telerehabilitation services. Each person's decision about clinic-based versus telerehabilitation service will stem from factors including funding, local availability and access, individual preference, and treatment team recommendations.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Telerehabilitation services; Physical therapy, occupational therapy, speech-language therapy, and/or counseling provided at home via telecommunication technologies.	Behavioral: outpatient rehabilitation; Treatment provided after completion of inpatient, acute rehabilitation.
Clinic-based rehabilitation services; Physical therapy, occupational therapy, speech-language therapy, and/or counseling provided at a local facility.	Behavioral: outpatient rehabilitation; Treatment provided after completion of inpatient, acute rehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life after Brain Injury	37-item questionnaire designed to measure six health-related quality of life dimensions for people with TBI	Change from baseline at 4 months
Changes in Outlook - Short	10-item self-report instrument assessing both positive and negative reactions to adversity and traumatic experiences.	Change from baseline at 4 months
Generalized Anxiety Disorder Screener - 7	7-item self-report instrument designed to screen for symptoms and severity of generalized anxiety in adults.	Change from baseline at 4 months
Beck Depression Inventory - II	21-item self-report instrument on which people rate their experience with depression symptoms within the past two weeks.	Change from baseline at 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Telerehabilitation or Clinic-based Post-acute Treatment Survey	Researcher-designed survey to capture perceptions about treatments received. It includes 2 questions about the length and intensity of physical therapy, occupational therapy, speech-language therapy, and counseling/psychology services and 15 items about the convenience, focus, and outcome of treatment as well as the quality of the therapist-client relationship.	4 months after study enrollment

Collaborators and Investigators

• Sponsor: Quality Living, Inc.
• Investigators: Principal Investigator: Karen Hux, Ph.D., Quality Living, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2021
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Therapy; Health-related Quality of Life
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: Tele Wellness

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