Enhancing the Transition From Hospital to Home for Patients With Traumatic Brain Injury and Families

NCT04584554 | Completed Results

• 1 other identifier: Pro00103181
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Despite high risks of readmission and complex medical needs, there are no transitional care standards in the U.S. for patients with moderate-to-severe traumatic brain injury (TBI) discharged home from acute hospital care without inpatient rehabilitation. To enhance the standard of TBI care, we will develop and refine a patient- and family-centered TBI transitional care intervention that addresses specific needs and preferences for patients with TBI (age \< 65 years) and families and will assess the feasibility, acceptability, and preliminary efficacy of the intervention.

Conditions

Brain Injuries, Traumatic; Transitional Care; Family Members; Patients

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life as Measured by the Short Form-36 (SF-36)

  The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scores on each item are summed and averaged (range: 0=worst to 100=best).

  Baseline (24-72 hours pre-discharge) and 16-weeks post-discharge

Secondary Outcomes (1)

• Change in Preparedness for Caregiving Scale (CPS)

  Baseline (24-72 hours pre-discharge) and 16-weeks post-discharge

Other Outcomes (3)

• Change in Health Service Utilization Inventory

  Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge

• Change in Modified Caregiver Strain Index

  Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge

• Change in Self-efficacy for Managing Chronic Conditions

  Baseline (24-72 hours pre-discharge) and 8- and 16-weeks post-discharge

Study Arms (1)

Intervention

EXPERIMENTAL

Behavioral: BETTER Transitional Care Intervention

Interventions

BETTER Transitional Care Intervention BEHAVIORAL

Patient and family will receive pre- and post-discharge support and education from interventionist.

Intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients: age 18-64 years, diagnosis of mild-moderate TBI based on Glasgow Coma Scale score of 9-14; sufficient cognitive functioning and oral communication skills to participate (as determined by Galveston Orientation and Amnesia Test); set to be discharged directly home from acute hospital care; and has smart phone or computer with internet access.
• Family caregiver: age 18 years or older, primary caregiver for patient post-discharge (i.e., plans to live in same home as person or have direct contact with person \>10 hours/week); and has smart phone or computer with internet access.

You may not qualify if:

• Patients: who do not have a family caregiver who is willing to participate; prior neurological disorder affecting the brain or language or learning disability

Sponsors & Collaborators

• Duke University: lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location

Related Publications (1)

• Oyesanya TO, Loflin C, You H, Kandel M, Johnson K, Strauman T, Yang Q, Hawes J, Byom L, Gonzalez-Guarda R, Van Houtven C, Agarwal S, Bettger JP. Design, methods, and baseline characteristics of the Brain Injury Education, Training, and Therapy to Enhance Recovery (BETTER) feasibility study: a transitional care intervention for younger adult patients with traumatic brain injury and caregivers. Curr Med Res Opin. 2022 May;38(5):697-710. doi: 10.1080/03007995.2022.2043657. Epub 2022 Mar 2.

  PMID: 35174756 DERIVED

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

Results Point of Contact

• Title: Tolu Oyesanya, PI of study
• Organization: Duke University School of Nursing

tolu.oyesanya@duke.edu

919-684-5292

Study Officials

• Tolu O Oyesanya, PhD, RN

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 15 patient/family dyads will undergo intervention

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: February 17, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: November 15, 2024
• Results First Posted: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)