Study of the Aliviado DSD Caregiving Mastery Program

January 22, 2026 updated by: NYU Langone Health

Development and Piloting of a Family-Centered, mHealth-Enhanced Intervention to Promote Caregiving Mastery in Detection, Prevention, and Management of Delirium Superimposed on Dementia

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Shih-Yin Lin
  • Phone Number: (720) 883-5715
  • Email: SL199@nyu.edu

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • NYU Langone Health
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants Who Complete the Study
Time Frame: Week 6
Measure of feasibility. Feasibility indicated by retention rate of 85%.
Week 6
Program Satisfaction Questionnaire Score: Satisfaction
Time Frame: Week 6
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
Time Frame: Week 6
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
Time Frame: Up to Week 2
Measure of acceptability.
Up to Week 2
Number of Participants Who Complete Weekly Delirium Screening at Least Twice by Week 6
Time Frame: Up to Week 6
Measure of acceptability.
Up to Week 6
Modified IBM Computer Usability Satisfaction Questionnaire Score
Time Frame: Up to Week 6
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 2
Time Frame: Baseline, Week 2
19-item assessment of caregivers' delirium knowledge. Item response options include "yes," "no," and "I don't know." Correct responses receive a score of 1, incorrect responses receive a score of 0. The total score ranges from 0-19; higher scores indicate greater delirium knowledge.
Baseline, Week 2
Change From Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 6
Time Frame: Baseline, Week 6
19-item assessment of caregivers' delirium knowledge. Item response options include "yes," "no," and "I don't know." Correct responses receive a score of 1, incorrect responses receive a score of 0. The total score ranges from 0-19; higher scores indicate greater delirium knowledge.
Baseline, Week 6
Change From Baseline in Modified Caregiver Strain Index Score at Week 6
Time Frame: Baseline, Week 6
13-item assessment of strain related to care provision. Items are scored on a Likert scale from 0 (no) to 2 (Yes, on a regular basis). The total score is the sum of responses and ranges from 0 to 26; higher scores indicate greater strain.
Baseline, Week 6
Change From Baseline in Center for Epidemiological Studies Depression Scale (CES-D) Score at Week 6
Time Frame: Baseline, Week 6
20-item assessment of symptoms of depression over the past 7 days. The total score ranges from 0 to 60, with higher scores indicating the presence of more symptomatology.
Baseline, Week 6
Change From Baseline in Short Form Zarit Burden Interview Score at Week 6
Time Frame: Baseline, Week 6
12-item assessment of caregiver burden. Items are scored on a Likert scale from 0 (never) to 4 (nearly always). The total score is the sum of responses and ranges from 0 to 48. A score of 0-10 indicates no to mild burden; 10-20 indicates mild to moderate burden; and greater than 20 indicates high burden.
Baseline, Week 6
Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at Week 2
Time Frame: Baseline, Week 2
4-item DSD Competence Scale modified from Pearline's Competence Scale. Each item is rated on a scale from 1-4. The total score is the sum of responses and ranges from 4 to 16. Higher scores indicate greater levels of mastery.
Baseline, Week 2
Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at Week 6
Time Frame: Baseline, Week 6
4-item DSD Competence Scale modified from Pearline's Competence Scale. Each item is rated on a scale from 1-4. The total score is the sum of responses and ranges from 4 to 16. Higher scores indicate greater levels of mastery.
Baseline, Week 6
Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 2
Time Frame: Baseline, Week 2
25-item DSD self-efficacy scale developed by the Aliviado team to assess confidence of DSD prevention, detection, and management tasks. Each item is rated on a scale from 0-100. The total score is the average of sum of non-missing responses and ranges from 0 to 100. Higher scores indicate greater levels of mastery.
Baseline, Week 2
Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 6
Time Frame: Baseline, Week 6
25-item DSD self-efficacy scale developed by the Aliviado team to assess confidence of DSD prevention, detection, and management tasks. Each item is rated on a scale from 0-100. The total score is the average of sum of non-missing responses and ranges from 0 to 100. Higher scores indicate greater levels of mastery.
Baseline, Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shih-Yin Lin, NYU Rory Meyers College of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 11, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 11, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22-01093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [SL199@nyu.edu]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings