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Trial record 51 of 314 for:    Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

Problem Solving Training for Care Partners of Adults With Traumatic Brain Injury (CP-PST)

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ClinicalTrials.gov Identifier: NCT03739450
Recruitment Status : Recruiting
First Posted : November 12, 2018
Last Update Posted : November 29, 2018
Sponsor:
Collaborators:
Baylor Health Care System
Kessler Institute for Rehabilitation
Hackensack Meridian Health
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:

Importance: The chronic consequences of TBI are established, but ongoing support for adults with TBI living in the community is limited. This puts undue burden on care partners, particularly during the transition from hospital to home. It often leads to adverse consequences among care partners, such as emotional distress and increased substance abuse. Currently, there are no evidence-based interventions for care partners of adults with TBI to prepare them for this role. Problem Solving Training (PST) is an evidence-based, self-management approach with demonstrated efficacy for care partners of individuals with disabilities, but it has not been delivered or evaluated during inpatient rehabilitation.

Aims: Aim 1): To assess the feasibility of providing PST to care partners of adults with TBI during the inpatient rehabilitation stay; Aim 2) To assess the efficacy of PST + education vs education alone for improving caregiver burden, depressive symptoms, and coping skills Method: The investigators will conduct a randomized control trial of PST + Education vs Education alone during the inpatient rehabilitation stay of individuals with TBI. The investigators will enroll 172 care partners and conduct baseline assessment, with follow-up assessment at 1 month and 6 months post-discharge. For Aim 1, the investigators will measure number of sessions of PST completed and care partner satisfaction. For Aim 2, the investigators will compare differences in PST+Educaion vs. Education alone in measures of caregiver burden, depressive symptoms, and coping skills at 1-month and 6-months post-discharge.

Conclusion: The investigators anticipate that care partners will be able to complete a minimum of 3 sessions during the inpatient rehabilitation stay and that PST + Education will be more effective than Education alone for reducing caregiver burden and depressive symptoms and improving positive coping among care partners. PST is an evidence-based, self-management approach with a strong theoretical foundation that has demonstrated efficacy for care partners of individuals with disabilities. Early work indicates that it is also effective for care partners of adults with TBI. However, there are no studies evaluating whether delivery of PST to care partners is feasible during inpatient rehabilitation. The proposed project builds upon this foundation of evidence to address this critical gap in the literature. It will provide evidence for effective ways to support and improve outcomes for care partners during the transition from hospital to home.


Condition or disease Intervention/treatment Phase
Care Partners of Patients With Traumatic Brain Injury (TBI) Behavioral: Problem Solving Training (PST) Behavioral: Education Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomized and allocated after baseline assessment to PST + Education or Education only via stratified, blocked randomization. Randomization is stratified by participating center and then based on whether a single care partner or multiple care partners are participating for the same patient by participating TBIMS Center. The investigators used a block size of four to ensure equal numbers across groups and to account for potentially small numbers of participants at any given TBIMS Center. Randomization is computer-generated and maintained by the TBI Model Systems National and Statistical Data Center. Allocation assignments for each center are distributed to the site PI and maintained in a password-protected electronic file. Outcome assessors are blinded to intervention allocation.
Masking: Single (Outcomes Assessor)
Masking Description: Blinding will be ensured by allocating to group assignment after baseline assessment is complete, having different staff performing assessments vs delivering the intervention, scheduling meetings with assessors and interventionists separately, and instructing participants to not discuss the intervention with the person calling to complete follow-up assessments.
Primary Purpose: Treatment
Official Title: Problem Solving Training for Care Partners of Adults With Traumatic Brain Injury
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : October 22, 2022
Estimated Study Completion Date : October 22, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Problem Solving Training + Education
Participants in this arm will receive the TBI-specific education intervention and the Problem Solving Training (PST) intervention.
Behavioral: Problem Solving Training (PST)
The PST intervention consists of six sessions that will follow a structured format based on the PST manual. In these sessions, the interventionist will first provide the TBI-specific education, introduce the participant to the PST steps, then help the care partner generate and select a problem to address first. Interventionist will facilitate the care partner's use of the ABCDEF steps of PST to develop a specific action plan to solve the problem. As problems are attempted or solved, the care partner will learn how to perform the steps on his/her own, thus acquiring self-management problem solving skills that will be applicable to future problems. The final session will include a review and generalization of the PST steps and progress made.

Behavioral: Education
Participants will receive TBI-specific education alone through a workbook. It consists of educational modules for self-study, common sequelae of TBI, issues encountered by care partners, work and school concerns for those with TBI, and on navigating the rehab system and accessing resources. The modules consist of a brief introduction, key definitions, examples, resources, and a summary. Some chapters also include self-directed activities, such as worksheets or checklists. The investigators will provide a brief orientation to the workbook and include open-ended questions about the participants' need for clarification or questions of the education material. The last session will consist of an open discussion about expected problems that may arise post-discharge.

Active Comparator: Education
Participants in this arm will only receive the TBI-specific education intervention.
Behavioral: Education
Participants will receive TBI-specific education alone through a workbook. It consists of educational modules for self-study, common sequelae of TBI, issues encountered by care partners, work and school concerns for those with TBI, and on navigating the rehab system and accessing resources. The modules consist of a brief introduction, key definitions, examples, resources, and a summary. Some chapters also include self-directed activities, such as worksheets or checklists. The investigators will provide a brief orientation to the workbook and include open-ended questions about the participants' need for clarification or questions of the education material. The last session will consist of an open discussion about expected problems that may arise post-discharge.




Primary Outcome Measures :
  1. Changes from T1 to T2 in the Patient Health Questionnaire (PHQ9) Changes from T2 to T3 in the PHQ9 T3 in the PHQ9 to measure maintenance of change Group/Arm differences at T2 in the PHQ9 [ Time Frame: Baseline (T1), 1-month (T2) and 6-month (T3) post-discharge between both arms ]
    The PHQ-9 assesses the frequency over the past two weeks of each of the nine symptoms of DSM-IV-TR that define a major depressive episode. Total scores range from 0-27, with established interpretative symptom cut-off scores of 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and >20 (severe).

  2. Changes T2 to T3 in the Zarit Burden Interview (ZBI) Group/Arm differences at T2 in the ZBI [ Time Frame: 1 month (T2) and 6 month (T3) post-discharge between both arms ]
    The ZBI is a self-reported measure of perceived caregiver burden, including psychological health, well-being, social and family life, finances, and perceive control. There are multiple versions of the ZBI, but the investigators will use the 22-item version (each scored on a 5-pt Likert Scale), because it has been found to have good internal consistency reliability (α=.92) and established reference values for interpretation (mild: 2-20; mild to moderate: 21-40; moderate to severe:41-60; severe: 61-88).


Secondary Outcome Measures :
  1. Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: Baseline, 1-month and 6-month post-discharge ]
    The AUDIT is a 10-item screening tool for alcohol use behaviors designed by the World Health Organization to screen for alcohol abuse.The AUDIT assesses consumption, drinking behaviors, and alcohol-related problems, with a score of >8 indicating harmful alcohol use.

  2. Brief Coping Orientation to Problems Experienced [ Time Frame: Baseline, 1-month and 6-month post-discharge ]
    The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Identified as care partner of an individual with TBI admitted to inpatient rehabilitation. A care partner is defined as an individual (spouse, partner, family member, friends, or neighbor) involved in assisting the patient with activities of daily living and/or medical tasks or responsible in any way for the patient's well-being after discharge from inpatient rehabilitation.
  2. >1-year relationship
  3. Ability to communicate in English.
  4. >18 years old
  5. Capacity to self-consent

Exclusion Criteria:

Dispute over care partner's role in the care of patient.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739450


Contacts
Contact: Valeria Silva, B.S. 214-648-9362 valeria.silva@utsouthwestern.edu
Contact: Shannon Juengst 214-648-5352 shannon.juengst@utsouthwestern.edu

Locations
United States, New Jersey
Kessler Foundation Not yet recruiting
East Hanover, New Jersey, United States, 07936
Contact: Belinda Washington, BA    973-324-8446    bwashington@kesslerfoundation.org   
Principal Investigator: Nancy Chiaravalloti, PhD         
Sub-Investigator: Jean Lengenfelder, PhD         
JFK Johnson Rehabilitation Institute Not yet recruiting
Edison, New Jersey, United States, 08820
Contact: Georgianna Dart, Psy.D.    732-321-7762    georgianna.dart@hackensackmeridian.org   
Contact: Yelena Goldin, Ph.D.    (732) 906-2903    yelena.goldin@hackensackmeridian.org   
Principal Investigator: Georgianna Dart, Psy.D.         
United States, Texas
Baylor Scott & White Institute for Rehabilitation Not yet recruiting
Dallas, Texas, United States, 75246
Contact: Amy Muir, MBA    214-820-9356    Aimee.Muir@BSWHealth.org   
Principal Investigator: Simon Driver, PhD         
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Valeria Silva, B.S.    214-648-9362    valeria.silva@utsouthwestern.edu   
Principal Investigator: Shannon Juengst, PhD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Baylor Health Care System
Kessler Institute for Rehabilitation
Hackensack Meridian Health
Investigators
Principal Investigator: Shannon Juengst, PhD UT Southwestern

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 602d

Publications:

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03739450     History of Changes
Other Study ID Numbers: STU 042018-052
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The IPD that will be shared includes the study protocol, the statistical analysis plan and the clinical study report.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: The research module data will remain under the control of the lead project team for one year after completion of data collection of the project. This will allow ample time for analyses and preparation of planned manuscripts. After the one-year period, any of the centers may request the data for additional analysis and dissemination. See SOP 6b for more details on internal procedures.
Access Criteria:

Both internal and external entities may request IPD through two separate procedures.

Internal Use:

Participating site in the TBI Model Systems may reference SOP 602b for further procedures.

External Use:

All staff, students, and other related personnel not involved in the NIDILRR-funded TBI Model Systems Centers or Follow-up Centers who wish to use data from the TBI Model Systems National Database or Modules may request access to the data set by completing a Data Request and Use Agreement Form available for download at www.tbindsc.org The Data Request and Use Agreement Form, once complete, can be emailed or faxed to the Project Director of the TBI Model Systems National Data and Statistical Center (see www.tbindsc.org and go to contacts).

Reference: SOP 602d

URL: https://www.tbindsc.org/StaticFiles/SOP/602d%20-%20External%20Use%20TBIMS%20National%20Database%20Notification.pdf

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System