Caregiving During Crisis

Study Overview
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Brief Summary
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This study will test a prototype pandemic caregiver training and education course designed for caregivers of persons living with dementia (PLWD). Participants will be randomized to take the course immediately or to take the course after completion of an 8-week waiting period.

Detailed Description
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Family caregivers, the backbone of care for the upwards of 7 million community-dwelling individuals living with Alzheimer's disease in the U.S., provide at least 85% of the care these individuals receive, at some risk to their own well-being, and are instrumental in navigating healthcare systems. Without their care, it is almost certain that persons living with dementia (PLWD) would have much higher rates of acute and emergency care use than their age-matched peers, perilous venues for them in the best of times, potentially deadly during this pandemic. With coronavirus disease 2019 (COVID-19) restrictions, the amount of care they provide and the expertise needed to provide the care will increase. Typically, caregivers are strangers in healthcare and pandemic landscapes, but they are now called on to enact home care and safety measures and navigate an intricate, complex, and opaque system without the benefit of a compass or a translator - and largely without understanding their role in or having the skills for navigating the system. A variety of interventions have demonstrated benefit in enhancing caregivers' caregiving capacities, with resulting positive outcomes for both caregivers and care recipients. Only a few of these useful interventions, Tele-Savvy among them, have employed distance delivery means, thus enabling rural caregivers and others precluded by circumstance from attending in-person programs to take part in the intervention programs. The study will assess a psychoeducational intervention for dementia caregivers. Participating caregivers will be randomized to immediately enroll in the study intervention or to be in a waitlist group that will begin the intervention 8 weeks later. Participants will complete interviews at baseline and after the 8-week study period.

Official Title
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Mastering the Challenges of Dementia Family Caregiving in a Time of COVID-19: An Online Course

Conditions
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Caregiver Stress Syndrome

Intervention / Treatment
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* Behavioral: Psychoeducational Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Providing care for a family member or friend with a confirmed diagnosis of dementia Lives in the community Co-resides with the PLWD Is the main caregiver for the PLWD Has access to a computer with internet service Can read and understand English Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychoeducational Intervention<br>Caregivers receiving the psychoeducational intervention immediately. | Behavioral: Psychoeducational Intervention<br>* The intervention is an online course providing education and training to caregivers over an 8 week period. The self-paced course provides information on caregiving for a PLWD during a pandemic, navigating the health care system for a PLWD, and managing daily life (including self-care).<br>|
| No Intervention: Waitlist<br>Caregivers on a waitlist to receive the psychoeducational intervention after a waiting period of 8 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Center for Epidemiologic Studies - Depression (CES-D) Scale Score | The CES-D is a 21-item self-report instrument asking respondents if they have experienced symptoms of depression during the past week. Responses are given on a scale of 1 to 4 where 1 = rarely and 4 = most of the time. Total scores range from 21 to 84 and higher scores indicate greater symptoms of depression. | Baseline, Week 8 | 
| Change in State-Trait Anxiety Inventory (STAI) Score | The STAI is a 20-item self-report scale of positive and negative anxiety experiences. Responses are given on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety. | Baseline, Week 8 | 
| Change in Perceived Stress Scale Score | The Perceived Stress Scale includes 14 items assessing self-reported caregiving stress. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 56 and higher values indicate greater perceived stress. | Baseline, Week 8 | 
| Change in Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score | The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate how frequently problems have occurred on a 5-point scale where 0 = never occurred and 4 = daily or more often. Total frequency scores range from 0 to 96 with higher scores indicating greater frequency of memory and behavior problems exhibited by the PLWD. | Baseline, Week 8 | 
| Change in Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score | The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate the degree to which problems have bothered or upset them on a 5-point scale where 0 = not at all and 4 = extremely. Total reaction scores range from 0 to 96 with higher scores indicating more bothered or upset by memory and behavior problems exhibited by the PLWD. | Baseline, Week 8 | 
| Change in Zarit Burden Interview Score | The Zarit Burden Interview is a 22-item scale of objective and subjective caregiver burden. Responses are given on a 5-point scale where 0 = never and 4 = nearly always. Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened with providing care. | Baseline, Week 8 | 
| Change in Caregiver Mastery Scales Score | The Caregiving Mastery instrument assesses caregiver mastery of 3 different realms of caregiving situations: Relational Deprivation, Caregiving Competence, and Management of Situation. The 14 items are responded to on a 4-point scale where 1 = not at all and 4 = completely. Total scores range from 14 to 56 where higher scores indicate greater feelings of mastery of caregiving. | Baseline, Week 8 | 
| Change in Caregiver Assessment of Behavioral Skill - Self-report Score | The Caregiver Assessment of Behavioral Skill - Self-report instrument is a 17-item caregiver self-assessment of perceived capacity to manage care situations. Responses are given on a 3-point scale where 0 = seldom true and 3 = true most of the time, for behaviors exhibited by or relevant to the PLWD. Total scores range from 0 to 51 where higher scores indicate perceived ability to manage providing care. | Baseline, Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia family caregiver, Online education