Brain Injuries, TraumaticNCT04794894
Wellness and Quality of Life Perceptions of People With Traumatic Brain Injury
An observational study of Brain Injuries, Traumatic, run by Quality Living, Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- outpatient rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2021to 24 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- outpatient rehabilitation
- Keywords
- Therapy, Health-related Quality of Life
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outpatient rehabilitationBehavioural
Treatment provided after completion of inpatient, acute rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation services | Physical therapy, occupational therapy, speech-language therapy, and/or counseling provided at home via telecommunication technologies. Receives: Behavioral: outpatient rehabilitation | |
| Clinic-based rehabilitation services | Physical therapy, occupational therapy, speech-language therapy, and/or counseling provided at a local facility. Receives: Behavioral: outpatient rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life after Brain Injury
37-item questionnaire designed to measure six health-related quality of life dimensions for people with TBI
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline at 4 months
Secondary outcomes (1)
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.
Measured: 4 months after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start16 Apr 2021
- Primary completion24 Jun 2026
- Study completion24 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quality Living, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Hux, Ph.D., Principal investigator, Quality Living, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794894
- Sponsor's protocol ID
- Tele Wellness
- Status last verified
- Jun 2026
- First submitted
- 9 Mar 2021
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wellness and Quality of Life Perceptions of People With Traumatic Brain Injury Receiving Post-acute Telerehabilitation Versus Clinic-based Services
- ClinicalTrials.gov ID
- NCT04794894
- Acronym / sponsor ID
- Tele Wellness
- Conditions
- Brain Injuries, Traumatic
- Keywords
- Therapy, Health-related Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Quality Living, Inc.University, hospital or other
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 24 Jun 2026 (actual)
- First posted
- 12 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation services | – | Behavioral: outpatient rehabilitationPhysical therapy, occupational therapy, speech-language therapy, and/or counseling provided at home via telecommunication technologies. |
| Clinic-based rehabilitation services | – | Behavioral: outpatient rehabilitationPhysical therapy, occupational therapy, speech-language therapy, and/or counseling provided at a local facility. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| outpatient rehabilitationTreatment provided after completion of inpatient, acute rehabilitation. | Behavioural | Clinic-based rehabilitation services, Telerehabilitation services |
Primary outcome
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
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.
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.
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.
1 secondary outcome
Telerehabilitation or Clinic-based Post-acute Treatment Survey
Time frame: 4 months after study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Hux, Ph.D. principal investigator
Quality Living, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by Quality Living, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life after Brain Injury (time frame: Change from baseline at 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.