Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389032
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-24
Brief Title:
PERSEVERE Peer Mentor Support and Caregiver Education in Lewy Body Dementia
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
PERSEVERE in Lewy Body Dementia A Randomized Controlled Trial of Peer Mentor Support and Caregiver Education
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Lewy Body Dementia LBD is the second most common form of degenerative dementia affecting at least 24 million US adults and the overwhelming majority of persons living with LBD PLBD are cared for by family caregivers LBD caregiver strain 1 exceeds that of non-LBD dementia caregivers 2 worsens caregiver physical and mental health and 3 increases the risk of PLBD hospitalization and institutionalization LBD progression is complicated by combined motor cognitive and neuropsychiatric decline and is punctuated by falls infections dehydration and neuropsychiatric symptoms leading to acute healthcare utilization Although family caregivers are uniquely positioned to identify and manage these challenges which may avert emergency department visits and reduce morbidity many caregivers lack the knowledge skills confidence resources and support to do so
The study team aims to 1 quantify the impact of PERSEVERE on caregiver knowledge attitudes mastery and strain 2 identify the intervention and mentor factors determining implementation fidelity and 3 test the effects of PERSEVERE on PLBD quality of life and healthcare utilization This will be accomplished in an NIH Behavioral Model Stage II national randomized attention-controlled 12-week trial of PERSEVERE in 502 LBD caregivers in partnership with the Lewy Body Dementia Association Parkinsons Foundation and LBD Caregiver Advisors The study team will match intervention arm caregivers with a trained peer mentor who will coach them through a modular theory-based curriculum on LBD knowledge and social support Attention-control participants will receive weekly curated links to educational materials The study team will identify immediate and delayed intervention effects including mediators of strain at 12 weeks and caregiver strain and PLBD outcomes at nine months Implementation fidelity and PLBD healthcare utilization will be tracked biweekly Qualitative methods will explore the intervention- and mentor-specific factors predicting fidelity mentee outcomes and retention Remote recruitment mentoring and community engagement strategies will maximize accessibility and inclusion of underrepresented caregiver groups Results will illuminate the extent to which leveraging prior LBD caregivers as expert interventionists can improve current caregiver outcomes and in turn PLBD outcomes These results will inform future adaptation and dissemination of this model for other conditions
The study team aims to 1 quantify the impact of PERSEVERE on caregiver knowledge attitudes mastery and strain 2 identify the intervention and mentor factors determining implementation fidelity and 3 test the effects of PERSEVERE on PLBD quality of life and healthcare utilization This will be accomplished in an NIH Behavioral Model Stage II national randomized attention-controlled 12-week trial of PERSEVERE in 502 LBD caregivers in partnership with the Lewy Body Dementia Association Parkinsons Foundation and LBD Caregiver Advisors The study team will match intervention arm caregivers with a trained peer mentor who will coach them through a modular theory-based curriculum on LBD knowledge and social support Attention-control participants will receive weekly curated links to educational materials The study team will identify immediate and delayed intervention effects including mediators of strain at 12 weeks and caregiver strain and PLBD outcomes at nine months Implementation fidelity and PLBD healthcare utilization will be tracked biweekly Qualitative methods will explore the intervention- and mentor-specific factors predicting fidelity mentee outcomes and retention Remote recruitment mentoring and community engagement strategies will maximize accessibility and inclusion of underrepresented caregiver groups Results will illuminate the extent to which leveraging prior LBD caregivers as expert interventionists can improve current caregiver outcomes and in turn PLBD outcomes These results will inform future adaptation and dissemination of this model for other conditions
Detailed Description:
Lewy body dementia LBD affects at least 24 million people in the US and is associated with cognitive motor and neuropsychiatric symptoms yielding higher morbidity and mortality than Alzheimers Disease LBD family caregiver strain 1 exceeds that of non-LBD dementia caregivers 2 worsens caregiver physical and mental health and 3 independently increases the risk of hospitalization and institutionalization for persons living with LBD PLBD While dementia caregiver intervention research has been considerable there has been minimal LBD caregiver research where challenges may be greatest PLBD have frequent emergency department ED visits and hospitalizations driven by falls infections dehydration and neuropsychiatric symptoms Although family caregivers are uniquely positioned to identify and manage these challenges which may reduce ED visits and morbidity many caregivers lack the knowledge skills confidence resources and support to do so NIA recognizes the gap in enhancing the knowledge and skills of dementia caregivers and the critical need to understand optimal intervention structure content mechanisms and delivery methods Without intervention high LBD caregiver strain is associated with poorer caregiver outcomes PLBD morbidity and institutionalization In non-LBD dementia and cancer disease-specific practical succinct psychosocial educational interventions and particularly those with peer mentoring-experienced caregivers coaching those earlier in the disease-have improved caregiver and patient outcomes
The long-term goal of this work is to improve PLBD outcomes by leveraging and creating a pipeline of knowledgeable supported family caregivers as interventionists The overall objectives are to determine the effects of Peer Mentor Support and Caregiver Education PERSEVERE on LBD caregiver outcomes define factors predicting fidelity efficacy and retention and explore PLBD impact In the PIs K23NS097615 and earlier work the study team established the ability of a labor-intensive interdisciplinary intervention with caregiver-focused educational materials to stabilize caregiver strain and PLBD quality of life QoL compared with the usual decline seen in one year The study team then refined educational materials in a caregiver peer mentoring pilot study and documented high retention and fidelity NIH Stage IaThe study team has since demonstrated its ability to 1 mitigate caregiver strain and PLBD QoL in novel interventions 2 recruit over 200 diverse LBD caregivers in two months time 3 train and retain LBD caregivers as peer mentor interventionists in an NIA-funded Stage Ib study and 4 pilot a theory-driven peer mentor-led educational intervention yielding high retention fidelity satisfaction and efficacy on key mediators of caregiver strain knowledge attitudes skills and mastery Given prior recruitment success achieving all of our target sample sizes in our past work preliminary data and longitudinal stakeholder engagement the study team proposes an NIH Stage II efficacy randomized attention-controlled trial of PERSEVERE in 502 LBD family caregivers The study team will evaluate immediate interventional effects on mediators of caregiver strain at 12 weeks and the delayed impact on strain health outcomes and PLBD six months later The central hypothesis Peer mentor-delivered LBD education and support will improve caregiver strain and its mediators and PLBD health outcomes compared with usual care The diverse collaborative team will use mixed methods and the RE-AIM framework to pursue the following specific aims
Aim 1 To quantify the impact of the PERSEVERE program-an LBD-specific peer mentor-supported educational intervention-on caregiver knowledge attitudes mastery and strain
1 Test the difference in LBD knowledge attitudes and mastery after 12 weeks of PERSEVERE intervention vs attention control condition weekly emailed resources without peer support among LBD family caregivers
2 Compare change in caregiver strain among active mentees vs control caregivers at nine months
Aim 2 To identify the intervention and peer mentor factors determining implementation fidelity
1 Quantify the reach adoption implementation and maintenance of PERSEVERE
2 Identify matching and mentor characteristics associated with mentee outcomes and mentor retention
Exploratory Aim 3 To test the effects of PERSEVERE on PLBD quality of life and healthcare utilization
1 Test the difference in caregiver-reported PLBD QoL from baseline to nine months between active vs control caregivers
2 Quantify the difference in combined ED and hospital visits for falls infection dehydration and neuropsychiatric symptoms between baseline and nine months for active and control PLBD
The long-term goal of this work is to improve PLBD outcomes by leveraging and creating a pipeline of knowledgeable supported family caregivers as interventionists The overall objectives are to determine the effects of Peer Mentor Support and Caregiver Education PERSEVERE on LBD caregiver outcomes define factors predicting fidelity efficacy and retention and explore PLBD impact In the PIs K23NS097615 and earlier work the study team established the ability of a labor-intensive interdisciplinary intervention with caregiver-focused educational materials to stabilize caregiver strain and PLBD quality of life QoL compared with the usual decline seen in one year The study team then refined educational materials in a caregiver peer mentoring pilot study and documented high retention and fidelity NIH Stage IaThe study team has since demonstrated its ability to 1 mitigate caregiver strain and PLBD QoL in novel interventions 2 recruit over 200 diverse LBD caregivers in two months time 3 train and retain LBD caregivers as peer mentor interventionists in an NIA-funded Stage Ib study and 4 pilot a theory-driven peer mentor-led educational intervention yielding high retention fidelity satisfaction and efficacy on key mediators of caregiver strain knowledge attitudes skills and mastery Given prior recruitment success achieving all of our target sample sizes in our past work preliminary data and longitudinal stakeholder engagement the study team proposes an NIH Stage II efficacy randomized attention-controlled trial of PERSEVERE in 502 LBD family caregivers The study team will evaluate immediate interventional effects on mediators of caregiver strain at 12 weeks and the delayed impact on strain health outcomes and PLBD six months later The central hypothesis Peer mentor-delivered LBD education and support will improve caregiver strain and its mediators and PLBD health outcomes compared with usual care The diverse collaborative team will use mixed methods and the RE-AIM framework to pursue the following specific aims
Aim 1 To quantify the impact of the PERSEVERE program-an LBD-specific peer mentor-supported educational intervention-on caregiver knowledge attitudes mastery and strain
1 Test the difference in LBD knowledge attitudes and mastery after 12 weeks of PERSEVERE intervention vs attention control condition weekly emailed resources without peer support among LBD family caregivers
2 Compare change in caregiver strain among active mentees vs control caregivers at nine months
Aim 2 To identify the intervention and peer mentor factors determining implementation fidelity
1 Quantify the reach adoption implementation and maintenance of PERSEVERE
2 Identify matching and mentor characteristics associated with mentee outcomes and mentor retention
Exploratory Aim 3 To test the effects of PERSEVERE on PLBD quality of life and healthcare utilization
1 Test the difference in caregiver-reported PLBD QoL from baseline to nine months between active vs control caregivers
2 Quantify the difference in combined ED and hospital visits for falls infection dehydration and neuropsychiatric symptoms between baseline and nine months for active and control PLBD
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AG079128-01A1 | NIH | None | httpsreporternihgovquickSearch1R01AG079128-01A1 |