Clinical trial NCT04794894: Wellness and Quality of Life Perceptions of People With Traumatic Brain Injury
Official title: Wellness and Quality of Life Perceptions of People With Traumatic Brain Injury Receiving Post-acute Telerehabilitation Versus Clinic-based Services
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Brain Injuries, Traumatic
Keywords: Therapy
Health-related Quality of Life
Lead sponsor: Quality Living, Inc.
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Quality of Life after Brain Injury
timeFrame: Change from baseline at 4 months
measure: Changes in Outlook - Short
timeFrame: Change from baseline at 4 months
measure: Generalized Anxiety Disorder Screener - 7
timeFrame: Change from baseline at 4 months
measure: Beck Depression Inventory - II
timeFrame: Change from baseline at 4 months
Secondary outcomes:
measure: Telerehabilitation or Clinic-based Post-acute Treatment Survey
timeFrame: 4 months after study enrollment
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Quality Living, Inc.
state: Nebraska
Study officials:
affiliation: Quality Living, Inc.
name: Karen Hux, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: