Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635876
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Caregivers Preparing for Their Own Health Care Emergency
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Piloting an Online Emergency Preparedness Toolkit for Caregivers Preparing for Their Own Health Care Emergency
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to help spousal caregivers of people with dementia be prepared in the case of their the caregivers own health emergency and ensure that in their absence the person with dementia receives the care they need Specifically we are evaluating an online Emergency Preparedness Toolkit EPT with and without tailored coaching The main questions it aims to answer are
Does the online EPT in combination with tailored coaching increase the success of spousal caregivers in completing the EPT compared to the EPT alone
Does the online EPT in combination with tailored coaching increase the success of spousal caregivers in identifying and engaging a standby caregiver compared to the EPT alone
Does the online EPT with tailored coaching increase spousal caregiver preparedness confidence and self-efficacy compared to the EPT alone
What other barriers do spousal caregivers face when identifying and engaging a standby caregiver for their spouse with dementia
There are 2 cohorts in this study
1 Cohort 1 Usability Testing Prior to the start of enrollment into the randomized controlled trial approximately 10 caregivers will participate in a preliminary developmental phase where the usability and functionality of the online EPT will be evaluated
2 Cohort 2 Clinical Trial Approximately 68 caregivers will be enrolled into the randomized controlled trial These caregivers will be randomized 11 to one of two groups
EPT-A Group This group will complete the EPT alone with no assistance from a coach However technical support will be provided as needed
EPT-C Group This group will complete the EPT with the assistance of a trained coach Technical support will also be provided as needed
Does the online EPT in combination with tailored coaching increase the success of spousal caregivers in completing the EPT compared to the EPT alone
Does the online EPT in combination with tailored coaching increase the success of spousal caregivers in identifying and engaging a standby caregiver compared to the EPT alone
Does the online EPT with tailored coaching increase spousal caregiver preparedness confidence and self-efficacy compared to the EPT alone
What other barriers do spousal caregivers face when identifying and engaging a standby caregiver for their spouse with dementia
There are 2 cohorts in this study
1 Cohort 1 Usability Testing Prior to the start of enrollment into the randomized controlled trial approximately 10 caregivers will participate in a preliminary developmental phase where the usability and functionality of the online EPT will be evaluated
2 Cohort 2 Clinical Trial Approximately 68 caregivers will be enrolled into the randomized controlled trial These caregivers will be randomized 11 to one of two groups
EPT-A Group This group will complete the EPT alone with no assistance from a coach However technical support will be provided as needed
EPT-C Group This group will complete the EPT with the assistance of a trained coach Technical support will also be provided as needed
Detailed Description:
Caregivers for people with dementia PWD make up a diverse group of individuals and can include family friends and paid direct care workers However those living in the same household frequently the spousepartner of the PWD provide the bulk of care and are instrumental to a PWDs quality of life Brodaty Donkin 2009 Ornstein et al 2019 Rykkje 2019 While providing care can be rewarding Tarlow et al 2004 some caregivers may feel caregiver burden and become self-neglectful eg eating poorly poor exercise habits sleep deprivation Perkins et al 2013 AARP National Alliance for Caregiving 2020 which has the potential to lead to poor health and outcomes among caregivers Pinquart Sörensen 2007 Adelman et al 2014 Serious unexpected health events such as hospitalization of the caregiver can become a major disruption In fact we found that a PWD is at a significant increased risk of hospitalization within six months if their spousal caregiver is hospitalized resulting in the break-up of the caregiving relationship Boxer et al 2023 Often the caregiver has not planned for such unexpected events where they may become ill Whitlatch Orsulic-Jeras 2018 Pearce et al 2012 Interventions which support a caregiver can reduce caregiver burden and delay or offset the need to place a PWD in a care facility Mittelman et al 2006 Yaffe et al 2002 Young et al 2020 There are numerous supports available for a caregiver to prepare for the eventual decline and adverse outcomes of a PWD This increased preparedness and confidence decreases caregiver distress Wawrziczny et al 2017 However there is a gap in structured support and planning for a caregiver with their own health crisis A recent study indicated that caregivers may feel prepared for their caregiving role but less prepared for someone else to assume the role of caregiving Turner et al 2023 Therefore we developed the Emergency Preparedness Toolkit EPT for caregivers to prepare for their own health emergency
The EPT focused on day-to-day care for the PWD guides a caregiver to identify a standby caregiver to immediately step in and successfully care for the PWD The EPT was developed using a user-centered mixed methods approach with stakeholder surveys interviews n488 and subsequent reviews by 142 spousal caregivers Findings from this work indicated that spousal caregivers need increased support to utilize this tool as well as the ability to tailor the EPT for their specific dyad needs Caregivers indicated the EPT prompted them to consider changes for the overall care plan for the PWD Users require the EPT to be adaptable responsive to changes as dementia advances and easily transferable between caregivers
Spousal caregivers are the target population for this work in that they usually live with the PWD and provide daily routine support to the PWD Spousal caregivers tend to be older more likely to have chronic conditions and therefore at higher risk for illness and hospitalization Thus spousal caregivers may glean the most benefit from being prepared for their own hospitalization We portend that efforts to prepare and support the spousal caregiver will benefit the outcomes of both spousal caregiver and PWD
The EPT focused on day-to-day care for the PWD guides a caregiver to identify a standby caregiver to immediately step in and successfully care for the PWD The EPT was developed using a user-centered mixed methods approach with stakeholder surveys interviews n488 and subsequent reviews by 142 spousal caregivers Findings from this work indicated that spousal caregivers need increased support to utilize this tool as well as the ability to tailor the EPT for their specific dyad needs Caregivers indicated the EPT prompted them to consider changes for the overall care plan for the PWD Users require the EPT to be adaptable responsive to changes as dementia advances and easily transferable between caregivers
Spousal caregivers are the target population for this work in that they usually live with the PWD and provide daily routine support to the PWD Spousal caregivers tend to be older more likely to have chronic conditions and therefore at higher risk for illness and hospitalization Thus spousal caregivers may glean the most benefit from being prepared for their own hospitalization We portend that efforts to prepare and support the spousal caregiver will benefit the outcomes of both spousal caregiver and PWD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None