Study of the Aliviado DSD Caregiving Mastery Program

NCT ID: NCT05630014

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2025-02-11

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).

Conditions

Delirium Superimposed on Dementia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Family Caregivers of PLWD at High Risk for Delirium

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.

Group Type: EXPERIMENTAL

Aliviado DSD Caregiving Mastery Program

Intervention Type: BEHAVIORAL

Family caregiver intervention consisting of mHealth-app based educational videos and articles; caregiver-administered assessment tools and care plans; and motivational push notification reminders and encouragements.

Interventions

Aliviado DSD Caregiving Mastery Program

Family caregiver intervention consisting of mHealth-app based educational videos and articles; caregiver-administered assessment tools and care plans; and motivational push notification reminders and encouragements.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shih-Yin Lin

Role: PRINCIPAL_INVESTIGATOR

NYU Rory Meyers College of Nursing

Locations

NYU Langone Health

New York, New York, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

22-01093

Identifier Type: -

Identifier Source: org_study_id