Clinical trial NCT05630014: Study of the Aliviado DSD Caregiving Mastery Program
Official title: Development and Piloting of a Family-Centered, mHealth-Enhanced Intervention to Promote Caregiving Mastery in Detection, Prevention, and Management of Delirium Superimposed on Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium Superimposed on Dementia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-11-29
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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 30 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.

Primary outcomes:
measure: Number of Participants who Complete the Study
timeFrame: Week 6
measure: Program Satisfaction Questionnaire Score
timeFrame: Week 6
measure: Number of Participants who Complete all Training Videos by Week 2
timeFrame: Up to Week 2
measure: Number of Participants who Complete Weekly Delirium Screening at Least Twice by Week 6
timeFrame: Up to Week 6
measure: Modified IBM Computer Usability Satisfaction Questionnaire Score
timeFrame: Week 6
Secondary outcomes:
measure: Change from Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 2
timeFrame: Baseline, Week 2
measure: Change from Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 6
timeFrame: Baseline, Week 6
measure: Change from Baseline in Modified Caregiver Strain Index Score at Week 6
timeFrame: Baseline, Week 6
measure: Change from Baseline in Center for Epidemiological Studies Depression Scale (CES-D) Score at Week 6
timeFrame: Baseline, Week 6
measure: Change from Baseline in Short Form Zarit Burden Interview Score at Week 6
timeFrame: Baseline, Week 6
measure: Change from Baseline in DSD Caregiving Mastery Assessment Score at Week 2
timeFrame: Baseline, Week 2
measure: Change from Baseline in DSD Caregiving Mastery Assessment Score at Week 6
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: NYU Rory Meyers College of Nursing
name: Shih-Yin Lin
role: PRINCIPAL_INVESTIGATOR
References: