Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04748666
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2021-02-05
Brief Title:
PST for Care Partners of Adults With Alzheimers and AlzheimerS-related Dementia
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Problem Solving Training PST for English- and Spanish-speaking Care Partners of Adults With Alzheimers and AlzheimerS-related Dementia
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Caregivers of individuals with Alzheimers 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 Alzheimers Research and Care Consortium Collaborative Research Grant entitled Problem Solving Training PST for English- and Spanish-speaking Care Partners of Adults with Alzheimers and Alzheimers 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-Alzheimers 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 AM 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
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 Alzheimers Research and Care Consortium Collaborative Research Grant entitled Problem Solving Training PST for English- and Spanish-speaking Care Partners of Adults with Alzheimers and Alzheimers 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-Alzheimers 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 AM 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
Detailed Description:
Over 65 million people in the United States currently provide informal ie unpaid care to an individual with a chronic illness or disability1 including the nearly 6 million adults currently living with Alzheimers disease AD2 Care partners of adults with AD and related dementias ADADRD often experience high caregiver burden leading to emotional distress depression problematic alcohol use health problems isolation and poor quality of life34 Interventions to reduce care partner stress may reverse the negative impact of caregiver burden5 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 conditions6
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 needed7-18 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 396 of the population of Texas19 but most care partner intervention studies exclude Spanish-speaking participants Our team has translated and culturally adapted PST specifically for Spanish-speaking care partners20 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 ADADRD Our multidisciplinary team has expertise in ADADRD 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 ADADRD 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 ADADRD
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
Hypothesis Monthly brief booster sessions vs no boosters will be optimal for improving emotional symptoms and burden of both English and Spanish speaking care partners 6 months after baseline
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
Aim 2 Identify factors associated with response to treatment
Hypothesis Response to treatment will be associated with age gender engagement in and uptake of PST working alliance and goal attainment To test this hypothesis the investigators will assess the extent to which each of these factors predicts response to PST change in outcome using multiple linear regression
Establishing specific guidelines for an evidence-based implementable problem-solving intervention for both English and Spanish speaking care partners will result in direct clinical application to improve care partner health and well-being and to improve care recipient health and quality of life The investigators will explore potential mechanisms of change for future prospective study This proposal directly aligns with the mission of TARCC to take novel and innovative approaches to increase participation of diverse and underserved populations promote collaboration across TARCC institutions and contribute to advancement in therapeutic interventions to improve the lives of individuals with AD and related dementias
Design The investigators will conduct a randomized control trial of PST for care partners of adults with ADADRD to assess the effects of number of sessions 3 vs 6 and brief telephone booster sessions boosters vs no boosters on depressive symptoms Patient Health Questionnaire-9 and caregiver burden Zarit Burden Interview The investigators will recruit n180 participants n45 per arm across our two enrollment sites and conduct assessments at baseline end of intervention and 6-months post-baseline Booster sessions will begin 1 month after completion of PST and will occur monthly thereafter up to 6-months post-baseline conditions
Randomization and Allocation Randomization will be stratified by language and gender then will occur in blocks of 16 ie 4 participants allocated to each of the 4 conditions within each block The investigators will uniformly sample ie equal probability random numbers from a set containing four 1s four 2s four 3s and four 4s to generate the randomization table within each block
Data Analysis Sample Size Determination The investigators will conduct Bayesian mixed-effect ordered logistic regression models with subject-specific random effects to identify the optimal intervention group for our two primary outcomes at 6-months post-baseline Aim 1 The investigators will apply the same statistical analysis approach to secondary outcome measures The posterior probability that receiving 6-sessions decreases the odds ratio of higher PHQ-9 and ZBI scores and that receiving a booster decreases the odds ratio of higher PHQ-9 and ZBI scores will be reported in lieu of a p-value which is inexistent in the Bayesian paradigm In accordance with the approach used to power the current study a significant result for any of the three treatments will be defined as a posterior probability greater than 9833 in order to achieve an overall experiment-wise significance level of 5 The investigators will apply the same statistical analysis approach to secondary care partner outcomes caregiver self-efficacy positive aspects of caregiving coping and alcohol use To identify factors associated with PST response to intervention Aim 2 the investigators will conduct the following exploratory analyses Based on the PHQ-9 minimal clinically important difference MCID for individual change of 5 points32 The investigators will categorize participants into one of three response to intervention groups Response group PHQ-9 score decrease by 5 points from baseline to 6-months No Change group PHQ-9 scores are within 5 points of baseline at 6-months and Decliner group PHQ-9 scores increase by 5 points at 6-months The investigators will examine predictors of response to intervention group using multinomial logistic regression The investigators will further explore predictors of change in primary and secondary outcomes from baseline to 6-months post-intervention using multiple linear regression
Based on 1000 iterations of a simulation of our pilot data PST to improve PHQ-9 in care partners in a different clinical population14 the sample size necessary to detect a 30 decrease in the odds ratio for those who received six sessions or a 30 decrease in the odds ratio for those who received booster sessions with at most 5 significance level and at least 80 power was found to be 23 per arm 4 arms per center 2 for a total of n184 total n203 accounting for 10 attrition
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 needed7-18 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 396 of the population of Texas19 but most care partner intervention studies exclude Spanish-speaking participants Our team has translated and culturally adapted PST specifically for Spanish-speaking care partners20 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 ADADRD Our multidisciplinary team has expertise in ADADRD 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 ADADRD 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 ADADRD
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
Hypothesis Monthly brief booster sessions vs no boosters will be optimal for improving emotional symptoms and burden of both English and Spanish speaking care partners 6 months after baseline
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
Aim 2 Identify factors associated with response to treatment
Hypothesis Response to treatment will be associated with age gender engagement in and uptake of PST working alliance and goal attainment To test this hypothesis the investigators will assess the extent to which each of these factors predicts response to PST change in outcome using multiple linear regression
Establishing specific guidelines for an evidence-based implementable problem-solving intervention for both English and Spanish speaking care partners will result in direct clinical application to improve care partner health and well-being and to improve care recipient health and quality of life The investigators will explore potential mechanisms of change for future prospective study This proposal directly aligns with the mission of TARCC to take novel and innovative approaches to increase participation of diverse and underserved populations promote collaboration across TARCC institutions and contribute to advancement in therapeutic interventions to improve the lives of individuals with AD and related dementias
Design The investigators will conduct a randomized control trial of PST for care partners of adults with ADADRD to assess the effects of number of sessions 3 vs 6 and brief telephone booster sessions boosters vs no boosters on depressive symptoms Patient Health Questionnaire-9 and caregiver burden Zarit Burden Interview The investigators will recruit n180 participants n45 per arm across our two enrollment sites and conduct assessments at baseline end of intervention and 6-months post-baseline Booster sessions will begin 1 month after completion of PST and will occur monthly thereafter up to 6-months post-baseline conditions
Randomization and Allocation Randomization will be stratified by language and gender then will occur in blocks of 16 ie 4 participants allocated to each of the 4 conditions within each block The investigators will uniformly sample ie equal probability random numbers from a set containing four 1s four 2s four 3s and four 4s to generate the randomization table within each block
Data Analysis Sample Size Determination The investigators will conduct Bayesian mixed-effect ordered logistic regression models with subject-specific random effects to identify the optimal intervention group for our two primary outcomes at 6-months post-baseline Aim 1 The investigators will apply the same statistical analysis approach to secondary outcome measures The posterior probability that receiving 6-sessions decreases the odds ratio of higher PHQ-9 and ZBI scores and that receiving a booster decreases the odds ratio of higher PHQ-9 and ZBI scores will be reported in lieu of a p-value which is inexistent in the Bayesian paradigm In accordance with the approach used to power the current study a significant result for any of the three treatments will be defined as a posterior probability greater than 9833 in order to achieve an overall experiment-wise significance level of 5 The investigators will apply the same statistical analysis approach to secondary care partner outcomes caregiver self-efficacy positive aspects of caregiving coping and alcohol use To identify factors associated with PST response to intervention Aim 2 the investigators will conduct the following exploratory analyses Based on the PHQ-9 minimal clinically important difference MCID for individual change of 5 points32 The investigators will categorize participants into one of three response to intervention groups Response group PHQ-9 score decrease by 5 points from baseline to 6-months No Change group PHQ-9 scores are within 5 points of baseline at 6-months and Decliner group PHQ-9 scores increase by 5 points at 6-months The investigators will examine predictors of response to intervention group using multinomial logistic regression The investigators will further explore predictors of change in primary and secondary outcomes from baseline to 6-months post-intervention using multiple linear regression
Based on 1000 iterations of a simulation of our pilot data PST to improve PHQ-9 in care partners in a different clinical population14 the sample size necessary to detect a 30 decrease in the odds ratio for those who received six sessions or a 30 decrease in the odds ratio for those who received booster sessions with at most 5 significance level and at least 80 power was found to be 23 per arm 4 arms per center 2 for a total of n184 total n203 accounting for 10 attrition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None