Improving Health Outcomes With Resource Facilitation

NCT04462549 | Completed

• 1 other identifier: 1811467577
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to test a service the investigators of the study believe may increase quality of life after brain injury and reduce the level of disability that might be associated with that injury. This intervention is called "Resource Facilitation" and involves working one on one with a brain injury specialist. This specialist is called a "Resource Facilitator" and will work with participants to help set and achieve their own goals along with a team of professionals that specialize in this kind of injury. If randomly assigned to the Resource Facilitation group, participants will receive Resource Facilitation free of charge. If not, they will be assigned to a control group and will not receive the intervention. However, both groups will receive calls every three months. During these calls, a research assistant will collect data about each participant's recovery and progress. If assigned to the Resource Facilitation group, participants may also receive study information in the mail if research assistants are unable to reach participants via telephone.

Conditions

Traumatic Brain Injury; Rehabilitation; Intervention

Keywords

Resource Facilitation

Outcome Measures

Primary Outcomes (5)

• Change in Patient reported outcome measurement information system (PROMIS): Health Related Quality of Life (HRQL)

  The PROMIS subscales are patient reported outcome measures available through NIH with excellent reliability and validity. The HRQL construct includes the following subscales: Depression, Anxiety, Physical Functioning, Social Participation, Pain Interference, Pain Intensity, Sleep Disturbance, and Fatigue. Higher scores suggest greater quality of life in the subscales above.

  3 months, 6 months, 9 months, 12 months, 15 months

• Change in Quality of Life after Brain Injury (QOLIBRI)

  This measures quality of life (QOL) symptoms unique to the brain injury population. Participants rate each statement from 1 (Not at all) to 5 (Very). Higher scores represent greater quality of life after experiencing brain injury

  3 months, 6 months, 9 months, 12 months, 15 months

• Change in Charlson Comorbidity List

  This list is a well-established list of comorbidities to chronic diseases based on the International Classification of Diseases (ICD) codes. The final score is a sum of weights associated with each comorbidity reported with higher scores representing an increased likelihood for resource use/mortality.

  3 months, 6 months, 9 months, 12 months, 15 months

• Change in Traumatic Brain Injury (TBI) Symptom and Functional Status Checklist

  This symptom checklist is not a normed, validated checklist, but rather a list of common brain injury symptoms observed both clinically and well-documented in the literature. This list is being piloted in this study but will provide a simple quantifier for TBI symptoms reported per patient. This form also includes key demographic information and variables that may change during the course of treatment (contact information, insurance, marital status, list of medications) that will not be considered primary outcomes.

  3 months, 6 months, 9 months, 12 months, 15 months

• Change in Mayo-Portland Adaptability Inventory - IV (MPAI-4)

  This measure is designed for outcome measurement after acquired brain injury in the post acute stage of recovery. The MPAI-4 is the product of 15 years of development using item response and classic psychometric theory and has established concurrent, construct, and predictive validity. There is a total score and subscale scores for Ability, Adjustment, and Participation Greater scores represent greater need in the subscales mentioned before.

  3 months, 6 months, 9 months, 12 months, 15 months

Secondary Outcomes (2)

• Change in Vocational Independence Scale - Revised (VIS-R)

  up to two weeks, 3 months, 6 months, 9 months, 12 months, 15 months

• Change in Survey of Unmet Needs and Services Utilized (SUNSU)

  3 months, 6 months, 9 months, 12 months, 15 months

Other Outcomes (3)

• Change in Headache Impact Test 6 (HIT6)

  Up to 2 weeks, 3 months, 6 months, 9 months, 12 months, 15 months

• Orientation Log (O-Log)

  Up to 2 weeks

• Change in Behavioral Rating Inventory of Executive Function-Adult Version (Brief-A)

  3 months, 6 months, 9 months, 12 months, 15 months

Study Arms (2)

Resource Facilitation

EXPERIMENTAL

This group is receiving Resource Facilitation

Behavioral: Resource Facilitation

Control

NO INTERVENTION

Not receiving Resource Facilitation

Interventions

Resource Facilitation BEHAVIORAL

RF involves working one on one with a brain injury specialist. This specialist is called a "Resource Facilitator" and works with clients to help set and achieve their own goals along with a team of professionals that specialize in this kind of injury. This may include brain injury education, family education, needs assessments, and service identification.

Resource Facilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented TBI (if one or more of the following criteria apply: Loss of consciousness of 30 minutes or more Post-traumatic anterograde amnesia of 24 hours or more Worst Glasgow Coma Scale full score in first 24 hours \< 13 (unless invalidataed upon review, e.g., attributable to intoxication, sedation, systemic shock)
• One or more of the following present: Intracerebral hematoma, Subdural hematoma, Epidural hematoma, Cerebral contusion, Hemorrhagic contusion, Penetrating TBI (dura penetrated), Subarachnoid hemorrhage, Brain stem injury
• Resides in one of the following counties: Vigo, Clay, Parke, Vermillion, Fountain, Warren, Tippecanoe, Montgomery, Putnam, Owen, Monroe, Brown, Morgan, Hendricks, Boone, Clinton, Howard, Tipton, Hamilton, Marion, Johnson, Bartholomew, Shelby, Hancock, Madison, Delaware, Henry, Rush, Decatur, Randolph, Wayne, Fayette, Union, or Franklin
• Age older than 17

You may not qualify if:

• From or going to jail or prison following injury
• Anyone with pre-existing progressive CNS disorder (this does not include previous TBI or stroke, for example)
• Being discharged from Acute Hospital LTAC
• Anyone who cannot interact with the environment
• Unable to follow commands

Sponsors & Collaborators

• Rehabilitation Hospital of Indiana: lead

Study Sites (1)

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46268, United States

Location

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Biostatistician

Model Details: Randomized Controlled Trial 100 subjects who will participate in this study will be randomly assigned to the Resource Facilitation Group. These subjects will receive resource facilitation services in addition to their regular rehabilitation follow-up services, and 50 subjects who will participate in this study will be randomly assigned to the Regular Follow-up Group, who will only receive their regular rehabilitation follow-up services/standard of care. Randomization will be generated within RedCap.

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: July 8, 2020
• Study Start: January 13, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)