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Aliviado DSD Program for Dementia Caregivers

N/A
Recruiting
Led By Shih-Yin Lin
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
To be eligible to participate in the feasibility trial, an individual must meet all of the following criteria: Being 18 years old or older, English-speaking, Providing at least 8 hours of unpaid care per week to, or living with, a community dwelling PLWD whose Delirium Risk Assessment Score >=5, Having the capacity to give informed consent, and Having a smartphone with Internet access.
To be eligible as a "dementia caregiver" in the co-design workshop, an individual must: be at least 18 years old, be English-speaking, provide at least 8 hours of unpaid care weekly or live with a community-dwelling PLWD, self-identify as unfamiliar with DSD, have the capacity to consent, and have Internet access
Must not have
Individuals who are blind or deaf will be excluded.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6
Awards & highlights
No Placebo-Only Group

Summary

This trial will develop and test an mHealth program to help family caregivers of dementia patients detect and manage delirium.

Who is the study for?
This trial is for English-speaking adults who provide at least 8 hours of unpaid care weekly or live with someone with dementia at high risk for delirium. They must be unfamiliar with DSD, able to consent, and have internet access via smartphone. Blind or deaf individuals cannot participate.
What is being tested?
The study tests the 'Aliviado DSD Caregiving Mastery Program,' designed to help family caregivers manage Delirium superimposed on Dementia (DSD) through a mobile health app and educational content over a 5-week workshop.
What are the potential side effects?
Since this intervention involves education and use of an mHealth app rather than medication, traditional side effects are not applicable. However, participants may experience stress or emotional discomfort while learning to manage DSD.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18, speak English, care for someone with dementia without pay, don't know much about DSD, can consent, and have Internet.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not blind or deaf.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Modified IBM Computer Usability Satisfaction Questionnaire Score
Number of Participants who Complete Weekly Delirium Screening at Least Twice by Week 6
Number of Participants who Complete all Training Videos by Week 2
+2 more
Secondary study objectives
Change from Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 2
Change from Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 6
Change from Baseline in Center for Epidemiological Studies Depression Scale (CES-D) Score at Week 6
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Family Caregivers of PLWD at High Risk for DeliriumExperimental Treatment1 Intervention
Participants will complete the Aliviado DSD Caregiving Mastery Program. This involves a caregiver education/training period from Week 0 to Week 2, and an implementation period from Week 3 to Week 6.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
856,047 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,805 Previous Clinical Trials
28,194,827 Total Patients Enrolled
Shih-Yin LinPrincipal InvestigatorNYU Rory Meyers College of Nursing

Media Library

Aliviado DSD Caregiving Mastery Program Clinical Trial Eligibility Overview. Trial Name: NCT05630014 — N/A
Acute confusional state Research Study Groups: Family Caregivers of PLWD at High Risk for Delirium
Acute confusional state Clinical Trial 2023: Aliviado DSD Caregiving Mastery Program Highlights & Side Effects. Trial Name: NCT05630014 — N/A
Aliviado DSD Caregiving Mastery Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05630014 — N/A
~2 spots leftby Feb 2025