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PST for Care Partners of Adults With Alzheimer's and Alzheimer'S-related Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04748666
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : September 22, 2021
Sponsor:
Collaborators:
University of Texas Rio Grande Valley
Texas A&M University
Information provided by (Responsible Party):
Shannon Juengst, University of Texas Southwestern Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Frontotemporal Degeneration (FTD) Lewy Body Dementia (LBD) Vascular Contributions to Cognitive Impairment and Dementia (VCID) Mixed Etiology Dementias (MED) Mild Cognitive Impairment (MCI) Behavioral: Problem Solving Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: The investigators will compare a) care partner emotional symptom (depression) change and b) caregiver burden change from baseline to 6-months post-baseline, to assessed long-term effects of PST and booster sessions several months beyond completion of the training. The investigators will also measure secondary care partner outcomes, including caregiver self-efficacy, positive aspects of caregiving, and alcohol use. Finally, the investigators will assess care partners' satisfaction, confidence using the PST strategy, and engagement across all conditions.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Problem Solving Training (PST) for English- and Spanish-speaking Care Partners of Adults With Alzheimer's and Alzheimer'S-related Dementia
Actual Study Start Date : June 14, 2021
Estimated Primary Completion Date : June 14, 2023
Estimated Study Completion Date : June 14, 2023


Arm Intervention/treatment
Experimental: 3 PST sessions and no boosters Behavioral: Problem Solving Training
Problem Solving Training (PST) is a metacognitive strategy training approach, grounded in self-management theory, 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.

Experimental: 3 PST sessions with monthly boosters for 6 months Behavioral: Problem Solving Training
Problem Solving Training (PST) is a metacognitive strategy training approach, grounded in self-management theory, 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.

Experimental: 6 PST sessions, no boosters Behavioral: Problem Solving Training
Problem Solving Training (PST) is a metacognitive strategy training approach, grounded in self-management theory, 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.

Experimental: 6 PST sessions with monthly boosters for 6 months Behavioral: Problem Solving Training
Problem Solving Training (PST) is a metacognitive strategy training approach, grounded in self-management theory, 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.




Primary Outcome Measures :
  1. The Mean Change in Patient Health Questionnaire (PHQ-8) Score [ Time Frame: 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).

  2. The Mean Change in Zarit Burden Interview Score [ Time Frame: 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


Secondary Outcome Measures :
  1. The Mean Change in Family Caregivers Scale/Caregiver experience Score [ Time Frame: Baseline, 6 months ]

    The Family Caregiving Scale (also referred to as the Caregiving Experience Scale) measures multiple dimensions mentioned below in detail. Higher scores indicate more of that particular scale.

    • Emotional well-being and physical health
    • Scales: Life Satisfaction, Social Support, and Carer Overload (scores from 6- 20, 7-35, and 3-15, respectively).
    • Caring Role
    • Scales: Satisfaction, Resentment, and Anger (scores from 6-30, 5-25, and 4-20, respectively).
    • Behavioral Problems Scales: Aggressive, Depressive, and Forgetfulness/confusion (scores from 9-36, 4-16, and 5-20, respectively).
    • Help provided by recipient Scales: Personal ADL/Instrumental ADL (scores from 0-7 and 0-4, respectively).
    • Help provided by carer Scales: Personal ADL/Instrumental ADL (scores from 0-7 and 0-4, respectively).
    • Family environment Scales: Closeness/Conflict (scores from 3-9 and 3-9, respectively).

  2. The Mean Change in Client Satisfaction Questionnaire (CSQ-8) Score [ Time Frame: 6 months ]
    Client Satisfaction Questionnaire (CSQ-8) is an 8-item measure of an individual's satisfaction with health-related services they have received, yielding a single summed score (ranging from 8 to 32) measuring overall satisfaction . Higher scores indicating high satisfaction.

  3. Upstream Social Isolation Risk Screener (U-SIRS13) [ Time Frame: Baseline, 6 months ]
    The Upstream Social Isolation Risk Screener (U-SIRS) is a 13-item scale that measures an individuals' feelings of disconnectedness, which encompasses aspects of social isolation and loneliness. The U-SIRS-13 yields a single summed score (ranging from 0 to 13) measuring overall risk of being disconnected. Higher scores indicate higher risk.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female, Male, Transgender/other
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT04748666


Contacts
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Contact: Valeria Silva, B.S. 2148659904 valeria.silva@utsouthwestern.edu
Contact: Care Partner Study CarePartnerStudy@UTSouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Valeria Silva, B.S.    214-865-9904    valeria.silva@utsw.edu   
Contact: Care Partner Study       carepartnerstudy@utsw.edu   
Principal Investigator: Shannon Juengst, PhD         
University of Texas Rio Grande Valley Recruiting
Edinburg, Texas, United States, 78539
Contact: Gladys Maestre, MD, PhD       gladys.maestre@utrgv.edu   
Principal Investigator: Gladys Maestre, MD, PhD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
University of Texas Rio Grande Valley
Texas A&M University
Investigators
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Principal Investigator: Shannon Juengst, Ph.D. University of Texas Southwestern Medical Center
Additional Information:
Publications:
Prince M, Guerchet M, Prina M. The Global Impact of Dementia 2013-2050. Alzheimer's Disease International; 2013.
Elliott TR, Shewchuk RM, Scott J. Family caregiver social problem-solving abilities and adjustment during the inital year of the caregiving role. J Couns Psychol. 2001;48(2):223-232. doi:10.1037/0022-0167.48.2.223
Hébert R, Bravo G, Préville M. Reliability, Validity and Reference Values of the Zarit Burden Interview for Assessing Informal Caregivers of Community-Dwelling Older Persons with Dementia<a href=
Clifford C, Greenfield TK. The UCSF Client Satisfaction Scales: I. The Client Satisfaction Questionnaire-8. In: The Use of Psychological Testing for Treatment Planning and Outcomes Assessment, 2nd Ed. Lawrence Erlbaum Associates Publishers; 1999:1333-1346.
Tarlow BJ, Wisniewski SR, Belle SH, Rubert M, Ory MG, Gallagher-Thompson D. Positive Aspects of Caregiving: Contributions of the REACH Project to the Development of New Measures for Alzheimer's Caregiving. Res Aging. 2004;26(4):429-453. doi:10.1177/0164027504264493
Hatcher RL, Gillaspy JA. Development and validation of a revised short version of the Working Alliance Inventory. Psychother Res. 2006;16(1):12-25.
Nezu AM, Nezu CM, D'Zurilla TJ. Solving Life's Problems. New York: Springer; 2007.
Malec JF. Goal Attainment Scaling in Rehabilitation. Neuropsychol Rehabil. 1999;9(3-4):253-275. doi:10.1080/096020199389365

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Responsible Party: Shannon Juengst, Assistant Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04748666    
Other Study ID Numbers: STU-2020-1276
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shannon Juengst, University of Texas Southwestern Medical Center:
Alzheimer Disease
Frontotemporal Degeneration
Lewy Body Dementia
Vascular contributions to cognitive impairment and dementia
Mixed etiology dementias
Mild Cognitive Impairment
Care partner
Caregiver
Alzheimer's-related Dementia
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Lewy Body Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Synucleinopathies