Study of the Aliviado DSD Caregiving Mastery Program

NCT05630014 | Completed Results

• 1 other identifier: 22-01093
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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 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

Outcome Measures

Primary Outcomes (6)

• Number of Participants Who Complete the Study

  Measure of feasibility. Feasibility indicated by retention rate of 85%.

  Week 6

• Program Satisfaction Questionnaire Score: Satisfaction

  Measure of acceptability. Acceptability was indicated by at least 80% of caregivers reporting high satisfaction. The questionnaire comprised 16 items, including 12 Likert-type questions assessing program satisfaction, one Yes/No question assessing caregivers' intention to make changes in how they provide care for PLWD based on what they learned from the program, and three open-ended questions for additional feedback. Each Likert-type item was rated on a 4-point scale (1 = strongly disagree; 2 = disagree; 3 = agree; 4 = strongly agree). The total satisfaction score was calculated as the sum of the 12 Likert-type items, yielding a possible range of 12-48, with higher scores indicating greater satisfaction (high satisfaction defined as a score \> 36). This outcome is measured as the number of participants with a high satisfaction score.

  Week 6

• Program Satisfaction Questionnaire Score: Intention to Change

  Measure of acceptability. Acceptability was indicated by at least 80% of caregivers responding "Yes" to the Yes/No question on the Program Satisfaction Questionnaire: "Will you make any changes in how you care for your relative or friend with dementia based on what you learned in this program?" This outcome is measured as the number of participants who answer "Yes" to the intention-to-change question.

  Week 6

• Number of Participants Who Complete All Training Videos by Week 2

  Measure of acceptability.

  Up to Week 2

• Number of Participants Who Complete Weekly Delirium Screening at Least Twice by Week 6

  Measure of acceptability.

  Up to Week 6

• Modified IBM Computer Usability Satisfaction Questionnaire Score

  Modified by the Aliviado team to assess the usability of mobile apps, it consists of (1) 22 Likert-type questions rated on a scale from 1 to 5 (1="Strongly Disagree"; 2 ="Disagree"; 3="Neither agree or disagree"; 4="Agree" 5="Strongly Agree") assessing app usability, content, and interface; (2) one 4-point item on readiness to launch; (3) three Yes/No questions assessing frequency of app use and internet connectivity; and (4) three open-ended questions to provide additional feedback. The total usability satisfaction score is calculated by averaging responses to the twenty-two 5-point Likert-type items related to app usability, content, and interface. A score of 4 or higher indicates high user satisfaction and good usability.

  Up to Week 6

Secondary Outcomes (9)

• Change From Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 2

  Baseline, Week 2

• Change From Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 6

  Baseline, Week 6

• Change From Baseline in Modified Caregiver Strain Index Score at Week 6

  Baseline, Week 6

• Change From Baseline in Center for Epidemiological Studies Depression Scale (CES-D) Score at Week 6

  Baseline, Week 6

• Change From Baseline in Short Form Zarit Burden Interview Score at Week 6

  Baseline, Week 6

Study Arms (1)

Family Caregivers of PLWD at High Risk for Delirium

EXPERIMENTAL

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.

Behavioral: Aliviado DSD Caregiving Mastery Program

Interventions

Aliviado DSD Caregiving Mastery Program 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.

Family Caregivers of PLWD at High Risk for Delirium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• Individuals who are blind or deaf will be excluded.

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• NYU Langone Health: lead

Study Sites (2)

NYU Langone Health

New York, New York, 10010, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Results Point of Contact

• Title: Shih-Yin Lin
• Organization: NYU Langone Health

SL199@nyu.edu

(720) 883-571

Study Officials

• Shih-Yin Lin

  NYU Rory Meyers College of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: November 29, 2022
• Study Start: December 20, 2023
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access to the data upon reasonable request. Requests should be directed toSL199@nyu.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)