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

Brain Injuries, Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04794894
• Other study ID #: Tele Wellness
• Status: Enrolling by invitation
• Start date: April 16, 2021
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: Quality Living, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Wounds and Injuries

Intervention

Behavioral:
• outpatient rehabilitation
Treatment provided after completion of inpatient, acute rehabilitation.

Locations

Country	Name	City	State
United States	Quality Living, Inc.	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Quality Living, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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