Study of the Aliviado DSD Caregiving Mastery Program

Delirium Superimposed on Dementia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05630014
• Other study ID #: 22-01093
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Shih-Yin Lin
• Phone: (720) 883-5715
• Email: SL199[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Delirium Superimposed on Dementia
• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants who Complete the Study	Measure of feasibility. Feasibility indicated by retention rate of 85%.	Week 6
Primary	Program Satisfaction Questionnaire Score	Questionnaire comprises 13 Likert-type questions to assess program satisfaction and willingness to recommend the program. Includes one optional open-ended question to provide additional feedback.	Week 6
Primary	Number of Participants who Complete all Training Videos by Week 2	Measure of acceptability.	Up to Week 2
Primary	Number of Participants who Complete Weekly Delirium Screening at Least Twice by Week 6	Measure of acceptability.	Up to Week 6
Primary	Modified IBM Computer Usability Satisfaction Questionnaire Score	Developed by the Aliviado team; consists of 24 Likert-type questions, plus 3 optional open-ended questions to provide additional feedback. Higher scores indicate greater usability.	Week 6
Secondary	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.	Baseline, Week 2
Secondary	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.	Baseline, Week 6
Secondary	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.	Baseline, Week 6
Secondary	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.	Baseline, Week 6
Secondary	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.	Baseline, Week 6
Secondary	Change from Baseline in DSD Caregiving Mastery Assessment Score at Week 2	14-item DSD Competence Scale modified from Pearline's Competence Scale with additional items developed by the Aliviado team to assess confidence and completion of DSD prevention, detection, and management tasks. Higher scores indicate greater levels of mastery.	Baseline, Week 2
Secondary	Change from Baseline in DSD Caregiving Mastery Assessment Score at Week 6	14-item DSD Competence Scale modified from Pearline's Competence Scale with additional items developed by the Aliviado team to assess confidence and completion of DSD prevention, detection, and management tasks. Higher scores indicate greater levels of mastery.	Baseline, Week 6