Sponsor study identifier
interventional
33
1 country
2
Study Start
December 20, 2023
Actual (reported)Primary Completion
February 11, 2025
Actual (reported)Study Completion
February 11, 2025
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 11, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 18, 2022
Actual (reported)November 29, 2022
Actual (reported)December 20, 2023
Actual (reported)February 11, 2025
Actual (reported)February 11, 2025
Actual (reported)February 10, 2026
Actual (reported)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
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
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
NYU Langone Health
New York, New York, 10010, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260, United States
Shih-Yin Lin
NYU Rory Meyers College of Nursing
33 participants (actual enrollment reported by the registry).
First Submitted
November 18, 2022
First Posted
November 29, 2022
Study Start
December 20, 2023
Actual (reported)Music Therapy as a Treatment for Delirium in Acutely Hospitalized Older Patients
Contact the study team to confirm eligibility.
Primary Completion
February 11, 2025
Actual (reported)Study Completion
February 11, 2025
Actual (reported)Last Updated
February 10, 2026
Results First Posted
February 10, 2026
Record last verified: 2026-01
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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Source: ClinicalTrials.gov.
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