跳至主要内容
临床试验/NCT04748666
NCT04748666已完成不适用

Problem Solving Training (PST) for English- and Spanish-speaking Care Partners of Adults With Alzheimer's and Alzheimer'S-related Dementia

University of Texas Southwestern Medical Center6 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2021年6月14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
6
主要终点
The Mean Change in Patient Health Questionnaire (PHQ-8) Score

研究概览

简要总结

Caregivers of individuals with Alzheimer's disease and related dementia rarely get the preparation or training they need to manage their caregiving responsibilities and to successfully balance their own self-care and their caregiving roles. As a result, caregivers often experience caregiver burden, emotional distress, and substance abuse. Therefore, there is a critical need to support the emotional and social functioning of caregivers to improve their health and well-being and to prevent caregiver burden and poor coping.

Problem solving training (PST) is an evidence-based approach that teaches and empowers individuals to solve emergent problems contributing to their depressive symptoms, helps improve coping skills and increases self-efficacy. However, critical gaps in knowledge and care remain regarding the necessary components of training (eg. How many sessions? What is the influence of personal factors?) that affect how effective PST is for individual caregivers. Finally, caregiver interventions have almost exclusively been tested in English-speaking caregivers, further contributing to existing health disparities among minority groups.

To address this critical need, Dr. Shannon Juengst, Assistant Professor of Physical Medicine and Rehabilitation was awarded a new Texas Alzheimer's Research and Care Consortium Collaborative Research Grant entitled, "Problem Solving Training (PST) for English- and Spanish-speaking Care Partners of Adults with Alzheimer's and Alzheimer's Related Dementia." For this project, Dr. Juengst has assembled a strong, multidisciplinary team with Dr. Gladys Maestre, Professor of Biomedical Sciences and Director of the NIA funded-Alzheimer's Disease Resource Center for Minority and Aging Research and Memory Disorders Center at UT Rio Grande Valley and Dr. Matthew Smith, Associate Professor of Environmental and Occupational Health and Co-Director of the Center for Population Health and Aging at Texas A&M University.

This project will establish the necessary guidelines for an evidence-based, implementable problem-solving intervention for both English- and Spanish-speaking caregivers to improve their health and well-being and identify potential mechanisms of action for such training.

详细描述

Over 65 million people in the United States currently provide informal (i.e. unpaid) care to an individual with a chronic illness or disability,1 including the nearly 6 million adults currently living with Alzheimer's disease (AD).2 Care partners of adults with AD and related dementias (AD/ADRD) often experience high caregiver burden, leading to emotional distress, depression, problematic alcohol use, health problems, isolation, and poor quality of life.3,4 Interventions to reduce care partner stress may reverse the negative impact of caregiver burden.5 The Global Impact of Dementia 2013-2050 policy brief specifically called for better education and skills training for care partners. Therefore, there is a critical need to provide evidence-based support to care partners so they can best manage their own lives and their care recipients' chronic health conditions.6

Problem-Solving Training (PST) is an evidence-based metacognitive strategy training approach that teaches a simple, systematic method for evaluating problems, generating and selecting solutions, developing specific goals and action plans, and evaluating and revising plans as needed.7-18 Individuals learn to set achievable goals under the coaching of a therapist and gain self-efficacy as they begin to see that the seemingly overwhelming problems are indeed solvable when approached in a stepwise, rational fashion. Few care partner interventions include problem-solving skills training to translate knowledge into meaningful action, leaving care partners struggling to effectively manage their own lives and their caregiving responsibilities. Additionally, as of 2018 Hispanic individuals make up roughly 39.6% of the population of Texas,19 but most care partner intervention studies exclude Spanish-speaking participants. Our team has translated and culturally adapted PST specifically for Spanish-speaking care partners,20 presenting the opportunity to close a critical health disparity among care partners in Texas. PST, in both English and Spanish, could be incorporated across clinical settings into existing education-based care partner interventions to fill the current gaps in clinical practice. PST for fcare partners may also improve care recipient outcomes as well.

Our long-term goal is to improve the health, well-being, and participation of care partners and individuals with AD/ADRD. Our multidisciplinary team has expertise in AD/ADRD and in delivering and evaluating PST. The investigators represent a multi-site collaborative leveraging the broader TARCC network. Our expertise and strong clinical and research environments ensure the rigor, clinical relevance, and feasibility of our proposed research. The investigators will conduct a multi-site randomized controlled trial with a factorial design of PST for care partners of adults with AD/ADRD to address the following specific aims:

Aim 1: Determine the optimal number of Problem Solving Training (PST) sessions and boosters to improve emotional symptoms and burden in English and Spanish speaking care partners of adults with AD/ADRD.

Hypothesis: Six PST sessions vs three sessions will be optimal for improving emotional symptoms and burden of both English and Spanish speaking care partners 6 months after baseline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

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

  • PHQ2 Score of 2 or higher and/or ZBI4 Score of 2 or higher
  • 18 years or older
  • Able to speak fluently in English or Spanish
  • Cognitively able to make decisions, as determined by ability to provide informed consent
  • Care partner/caregiver to individual with AD/ADRD
  • Individual must have at least one year or more of a relationship with patient with AD/ADRD

排除标准

  • Dispute over care partner's role in the care of patient
  • Has previously participated in other PST study at UTSW within the past year
  • Does not meet all the inclusion criteria

结局指标

主要结局

The Mean Change in Patient Health Questionnaire (PHQ-8) Score

时间窗: Baseline, 6 months

Patient Health Questionnaire (PHQ-9) assesses DSIM-IV-TR symptoms that define major depressive episode. Scores range from 0-27 for severity. The PHQ8 omits the final question about suicidality, resulting in a validated scale with scores ranging from 0-24.: 0-4 (none), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and \>20 (severe).

The Mean Change in Zarit Burden Interview Score

时间窗: Baseline, 6 months

Zarit Burden Interview (ZBI) is a 22-item self-reported measure of perceived caregiver burden, including items related to psychological and emotional health, well-being, social and family life, finances, and perceive control. Cutoff scores are mild: 2-20; mild to moderate: 21-40; moderate to severe:41-60; severe: 61-88 burden

次要结局

  • The Mean Change in Family Caregivers Scale/Caregiver experience Score(Baseline, 6 months)
  • Upstream Social Isolation Risk Screener (U-SIRS13)(Baseline, 6 months)
  • The Mean Change in Client Satisfaction Questionnaire (CSQ-8) Score(6 months)

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 (6)

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