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临床试验/NCT03739450
NCT03739450已完成不适用

Problem Solving Training for Care Partners of Adults With Traumatic Brain Injury

University of Texas Southwestern Medical Center8 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2018年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
8
主要终点
Changes From T2 to T3 in the Patient Health Questionnaire (PHQ9)

研究概览

简要总结

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.

详细描述

North TX TBIMS Module Project: Problem Solving Training (PST) for Care Partners of Adults with Traumatic Brain Injuries (TBI) during Inpatient Rehabilitation

Care partners of adults with TBI report substantial burden and emotional distress and a need for more resources and skills training to manage the transition from hospital to home.

The investigators will assess the feasibility and efficacy of Problem Solving Training for care partners during inpatient rehabilitation to reduce burden and depressive symptoms and improve coping across the critical transition from inpatient rehabilitation to the community.

Statement of Problem: The chronic consequences of TBI are recognized, 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.1,2 Care partners of individuals with TBI often experience high levels of burden, which may result in depression, anxiety, increased somatic symptoms, and reduced quality of life.1,3,4 Care partner burden is largely predicted by the extent to which care partners' perceived needs are met.1,5,6 As the consequences of TBI continue to change over time, so too do the perceived needs of care partners.7-11 One study suggests that only 55% of care partner needs are perceived as being met.12 A systematic review of qualitative studies for care partners of adults with stroke revealed seven themes with regard to experiences, needs, and preferences of care partners during inpatient rehabilitation.13 Care partners expressed a desire to be included, informed, and recognized as a stakeholder in recovery, the need to navigate an alien culture and environment, and the need to manage the transition home.13 The authors concluded that "the investigators need to make deliberate efforts to provide a more inclusive environment that better supports and prepares carers for their new role".13 Despite this established need during inpatient rehabilitation, there are currently no evidence-based interventions for care partners of adults with TBI to prepare them for their new role prior to discharge of care recipients from inpatient rehabilitation. Hence, there is a critical need to provide care partners of individuals with TBI with the necessary skills to navigate this difficult transition from hospital to home.14 Self-management training for care partners of adults with other chronic conditions demonstrates strong potential for application to care partners of adults with TBI.

Proposed Solution: Problem-Solving Training (PST) is an evidence-based, self-management approach that teaches a simple, systematic method for evaluating problems, generating and selecting solutions, creating and implementing realistic goals and action plans, and evaluating whether those plans effectively addressed the specific goal.15,16 A growing body of evidence indicates that PST post-discharge is associated with reduced distress among care partners of adults with TBI.17-19 Problems previously seen as overwhelming are regarded as solvable and manageable when approached in a stepwise fashion using PST, thereby reducing perceived burden and emotional distress. PST empowers care partners to be active participants in directing health and rehabilitation services.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.
  • >1-year relationship
  • Ability to communicate in English.
  • >18 years old
  • Capacity to self-consent

排除标准

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

结局指标

主要结局

Changes From T2 to T3 in the Patient Health Questionnaire (PHQ9)

时间窗: 1-month (T2), 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).(positive = improvement)

Changes T2 to T3 in the Zarit Burden Interview (ZBI) Group/Arm Differences at T2 in the ZBI

时间窗: 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). (positive = improvement)

次要结局

  • Alcohol Use Disorders Identification Test (AUDIT)(Baseline and 6-month post-discharge)
  • Brief Coping Orientation to Problems Experienced(1-month (T2) and 6-month (T3) post-discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shannon Juengst

Assistant Professor

University of Texas Southwestern Medical Center

研究点 (8)

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