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

NCT04794894 | Enrolling By Invitation

• 1 other identifier: Tele Wellness
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries, Traumatic

Keywords

Therapy; Health-related Quality of Life

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Telerehabilitation or Clinic-based Post-acute Treatment Survey

  4 months after study enrollment

Study Arms (2)

Telerehabilitation services

Physical therapy, occupational therapy, speech-language therapy, and/or counseling provided at home via telecommunication technologies.

Behavioral: outpatient rehabilitation

Clinic-based rehabilitation services

Physical therapy, occupational therapy, speech-language therapy, and/or counseling provided at a local facility.

Behavioral: outpatient rehabilitation

Interventions

outpatient rehabilitation BEHAVIORAL

Treatment provided after completion of inpatient, acute rehabilitation.

Clinic-based rehabilitation services; Telerehabilitation services

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quality Living, Inc.: lead

Study Sites (1)

Quality Living, Inc.

Omaha, Nebraska, 68104, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Karen Hux, Ph.D.

  Quality Living, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: April 16, 2021
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)