N/A
N=32
Study of the Aliviado DSD Caregiving Mastery Program
Delirium Superimposed on Dementia
Bottom Line
View on ClinicalTrials.gov: NCT05630014 ↗Enrolled (actual)
32
Serious AEs
3.9%
Results posted
Feb 2026
Primary outcome: Primary: Number of Participants Who Complete the Study — 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aliviado DSD Caregiving Mastery Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Complete the Study |
26 | — |
| PRIMARY Program Satisfaction Questionnaire Score: Satisfaction |
26 | — |
| PRIMARY Program Satisfaction Questionnaire Score: Intention to Change |
26 | — |
| PRIMARY Number of Participants Who Complete All Training Videos by Week 2 |
29 | — |
| PRIMARY Number of Participants Who Complete Weekly Delirium Screening at Least Twice by Week 6 |
26 | — |
| PRIMARY Modified IBM Computer Usability Satisfaction Questionnaire Score |
4.41 | — |
| SECONDARY Change From Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 2 |
3.86 | — |
| SECONDARY Change From Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 6 |
3.81 | — |
| SECONDARY Change From Baseline in Modified Caregiver Strain Index Score at Week 6 |
0.04 | — |
| SECONDARY Change From Baseline in Center for Epidemiological Studies Depression Scale (CES-D) Score at Week 6 |
-2.15 | — |
| SECONDARY Change From Baseline in Short Form Zarit Burden Interview Score at Week 6 |
-2.15 | — |
| SECONDARY Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at Week 2 |
1.62 | — |
| SECONDARY Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at Week 6 |
2.73 | — |
| SECONDARY Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 2 |
3.59 | — |
| SECONDARY Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 6 |
6.6 | — |
Summary
Delirium superimposed on dementia (DSD) is an acute and serious condition that is common in persons living with dementia (PLWD). Involvement of family caregivers may aid prevention, early detection, and management of DSD. The purpose of the proposed study is two-fold. First, the investigators will develop a family-centered, mHealth-enhanced DSD caregiving mastery program ("Aliviado DSD Caregiving Mastery Program") through a 5-week co-design workshop with 8 family caregivers (Aim 1). The investigators will adapt/refine the existing clinician-centered DSD contents and an mHealth app from the evidence-based "Aliviado Dementia Care" program for use by family caregivers to support their day-to-day implementation of DSD detection, prevention, and management tasks in the community. Second, the investigators will pilot test the full Aliviado DSD Caregiving Mastery Program with family caregivers of PLWD at high risk for delirium, assessing feasibility, acceptability, app usability, and preliminary program impact (Aim 2).
Eligibility Criteria
Inclusion Criteria
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
To be eligible as a "DSD caregiver" in the co-design workshop, an individual must:
- be at least 18 years old,
- be English-speaking,
- be a current or past dementia caregiver with experience caring for a relative or friend during his/her DSD episode within the past 12 months,
- have the capacity to consent, and
- have Internet access.
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.
Exclusion Criteria
- Individuals who are blind or deaf will be excluded.
Data sourced from ClinicalTrials.gov (NCT05630014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.