NCT00692575

Brief Summary

This study seeks to determine if problem-based telephone counseling improves quality of life and emotional well-being for caregivers of persons with moderate to severe traumatic brain injury (TBI).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

4.3 years

First QC Date

June 3, 2008

Last Update Submit

April 10, 2014

Conditions

Brain Injuries

Keywords

Brain Injuries, TraumaticCaregivers

Outcome Measures

Primary Outcomes (1)

  • Composite measure based on the Bakas Caregiving Outcomes Scale and the Brief Symptom Inventory

    6 mos and 1 year post discharge home

Secondary Outcomes (5)

  • Caregiver community participation as measured by the PART-O

    6 mos and 1 year post discharge home

  • Caregiver employment

    6 mos and 1 year post discharge home

  • Caregiver resource utilization

    6 mos and 1 year post discharge home

  • Perceived Quality of Life (person with TBI)

    6 mos post discharge home

  • Brief Symptom Inventory (person with TBI)

    6 mos post discharge home

Study Arms (2)

1: Experimental

EXPERIMENTAL

Problem-solving, education based telephone counseling.

Behavioral: Problem-solving, education based telephone counseling

2: No intervention

SHAM COMPARATOR

Standard of care control group

Other: No Intervention

Interventions

Problem-solving, education based telephone counselingBEHAVIORAL

Caregivers are contacted every 2 weeks for 16-20 weeks after discharge of TBI survivor home. A caregiver support specialist provides telephone counseling based on a problem-solving, educational model.

1: Experimental
No InterventionOTHER

The control group will receive standard of care, i.e., typical resources and/or supports offered to caregivers of persons with TBI.

Also known as: Standard of care
2: No intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Family member or other person having a long-term relationship (at least one year) with person with TBI admitted to hospital and discharged home from acute care, inpatient rehabilitation, and/or skilled nursing facility within 7 months of date of injury.
  • Sufficient English to permit communication without an interpreter.

You may not qualify if:

  • Lack of a telephone.
  • Lack of a permanent home address.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

  • Powell JM, Wise EK, Brockway JA, Fraser R, Temkin N, Bell KR. Characteristics and Concerns of Caregivers of Adults With Traumatic Brain Injury. J Head Trauma Rehabil. 2017 Jan/Feb;32(1):E33-E41. doi: 10.1097/HTR.0000000000000219.

    PMID: 27022956DERIVED

  • Powell JM, Fraser R, Brockway JA, Temkin N, Bell KR. A Telehealth Approach to Caregiver Self-Management Following Traumatic Brain Injury: A Randomized Controlled Trial. J Head Trauma Rehabil. 2016 May-Jun;31(3):180-90. doi: 10.1097/HTR.0000000000000167.

    PMID: 26394294DERIVED

MeSH Terms

Conditions

Brain InjuriesBrain Injuries, Traumatic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Janet M. Powell, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Kathleen R. Bell, MD

    University of Washington

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 6, 2008

Study Start

June 1, 2008

Primary Completion

September 1, 2012

Study Completion

April 1, 2013

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations

US(1)