Delirium Superimposed on DementiaNCT05630014
Study of the Aliviado DSD Caregiving Mastery Program
A study testing Aliviado DSD Caregiving Mastery Program in people with Delirium Superimposed on Dementia, run by NYU Langone Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium Superimposed on Dementia
- What is being tested?
- Aliviado DSD Caregiving Mastery Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Dec 2023to 11 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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.
Who cannot join
- Individuals who are blind or deaf will be excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NYU Langone Health
New York, New York, 10010
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
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
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
- Being tested
- Aliviado DSD Caregiving Mastery Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aliviado DSD Caregiving Mastery ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Aliviado DSD Caregiving Mastery Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Complete the Study
Measure of feasibility. Feasibility indicated by retention rate of 85%.
Measured: 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.
Measured: 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.
Measured: Week 6
Number of Participants Who Complete All Training Videos by Week 2
Measure of acceptability.
Measured: Up to Week 2
Number of Participants Who Complete Weekly Delirium Screening at Least Twice by Week 6
Measure of acceptability.
Measured: 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.
Measured: Up to Week 6
Secondary outcomes (9)
Change From Baseline in Caregiver Delirium Knowledge Questionnaire Score at 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.
Measured: Baseline, Week 2
Change From Baseline in Caregiver Delirium Knowledge Questionnaire Score at 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.
Measured: Baseline, Week 6
Change From Baseline in Modified Caregiver Strain Index Score at 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.
Measured: Baseline, Week 6
Change From Baseline in Center for Epidemiological Studies Depression Scale (CES-D) Score at 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.
Measured: Baseline, Week 6
Change From Baseline in Short Form Zarit Burden Interview Score at 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.
Measured: Baseline, Week 6
Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at 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.
Measured: Baseline, Week 2
Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at 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.
Measured: Baseline, Week 6
Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at 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.
Measured: Baseline, Week 2
Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at 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.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start20 Dec 2023
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Delirium Superimposed on DementiaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Shih-Yin Lin, Principal investigator, NYU Rory Meyers College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630014
- Sponsor's protocol ID
- 22-01093
- Status last verified
- Jan 2026
- First submitted
- 18 Nov 2022
- Last updated
- 10 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05630014
- Acronym / sponsor ID
- 22-01093
- Conditions
- Delirium Superimposed on Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 20 Dec 2023 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Posted 10 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family Caregivers of PLWD at High Risk for Delirium | Experimental | Behavioral: Aliviado DSD Caregiving Mastery ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals who are blind or deaf will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aliviado DSD Caregiving Mastery ProgramFamily 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. | Behavioural | Family Caregivers of PLWD at High Risk for Delirium |
Primary outcome
Number of Participants Who Complete the Study
Time frame: Week 6
Measure of feasibility. Feasibility indicated by retention rate of 85%.
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.
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.
Number of Participants Who Complete All Training Videos by Week 2
Time frame: Up to Week 2
Measure of acceptability.
Number of Participants Who Complete Weekly Delirium Screening at Least Twice by Week 6
Time frame: Up to Week 6
Measure of acceptability.
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.
9 secondary outcomes
Change From Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 2
Time frame: Baseline, Week 2
Change From Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 6
Time frame: Baseline, Week 6
Change From Baseline in Modified Caregiver Strain Index Score at Week 6
Time frame: Baseline, Week 6
Change From Baseline in Center for Epidemiological Studies Depression Scale (CES-D) Score at Week 6
Time frame: Baseline, Week 6
Change From Baseline in Short Form Zarit Burden Interview Score at Week 6
Time frame: Baseline, Week 6
Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at Week 2
Time frame: Baseline, Week 2
Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at Week 6
Time frame: Baseline, Week 6
Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 2
Time frame: Baseline, Week 2
Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 6
Time frame: Baseline, Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shih-Yin Lin principal investigator
NYU Rory Meyers College of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aliviado DSD Caregiving Mastery Program in people with Delirium Superimposed on Dementia, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Complete the Study (time frame: Week 6). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.