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

Sponsor
Quality Living, Inc. (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04794894
Collaborator
(none)
50
1
23.5
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: outpatient rehabilitation

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Wellness and Quality of Life Perceptions of People With Traumatic Brain Injury Receiving Post-acute Telerehabilitation Versus Clinic-based Services
Actual Study Start Date :
Apr 16, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Quality of Life after Brain Injury [Change from baseline at 4 months]

    37-item questionnaire designed to measure six health-related quality of life dimensions for people with TBI

  2. Changes in Outlook - Short [Change from baseline at 4 months]

    10-item self-report instrument assessing both positive and negative reactions to adversity and traumatic experiences.

  3. Generalized Anxiety Disorder Screener - 7 [Change from baseline at 4 months]

    7-item self-report instrument designed to screen for symptoms and severity of generalized anxiety in adults.

  4. Beck Depression Inventory - II [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.

Secondary Outcome Measures

  1. Telerehabilitation or Clinic-based Post-acute Treatment Survey [4 months after study enrollment]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Quality Living, Inc. Omaha Nebraska United States 68104

Sponsors and Collaborators

  • Quality Living, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Quality Living, Inc.
ClinicalTrials.gov Identifier:
NCT04794894
Other Study ID Numbers:
  • Tele Wellness
First Posted:
Mar 12, 2021
Last Update Posted:
Aug 16, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Quality Living, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2021