Back to resultsStudy of the Aliviado DSD Caregiving Mastery Program
Primary Purpose
Delirium Superimposed on Dementia
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aliviado DSD Caregiving Mastery Program
Sponsored by
About this trial
This is an interventional supportive care trial for Delirium Superimposed on Dementia
Eligibility Criteria
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.
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Family Caregivers of PLWD at High Risk for Delirium
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants who Complete the Study
Measure of feasibility. Feasibility indicated by retention rate of 85%.
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.
Number of Participants who Complete all Training Videos by Week 2
Measure of acceptability.
Number of Participants who Complete Weekly Delirium Screening at Least Twice by Week 6
Measure of acceptability.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05630014
First Posted
November 18, 2022
Last Updated
August 31, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05630014
Brief Title
Study of the Aliviado DSD Caregiving Mastery Program
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2023 (Anticipated)
Primary Completion Date
March 22, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 30 family caregivers of PLWD at high risk for delirium, assessing feasibility, acceptability, app usability, and preliminary program impact (Aim 2).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium Superimposed on Dementia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Family Caregivers of PLWD at High Risk for Delirium
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aliviado DSD Caregiving Mastery Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants who Complete the Study
Description
Measure of feasibility. Feasibility indicated by retention rate of 85%.
Time Frame
Week 6
Title
Program Satisfaction Questionnaire Score
Description
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.
Time Frame
Week 6
Title
Number of Participants who Complete all Training Videos by Week 2
Description
Measure of acceptability.
Time Frame
Up to Week 2
Title
Number of Participants who Complete Weekly Delirium Screening at Least Twice by Week 6
Description
Measure of acceptability.
Time Frame
Up to Week 6
Title
Modified IBM Computer Usability Satisfaction Questionnaire Score
Description
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.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Change from Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 2
Description
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.
Time Frame
Baseline, Week 2
Title
Change from Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 6
Description
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.
Time Frame
Baseline, Week 6
Title
Change from Baseline in Modified Caregiver Strain Index Score at Week 6
Description
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.
Time Frame
Baseline, Week 6
Title
Change from Baseline in Center for Epidemiological Studies Depression Scale (CES-D) Score at Week 6
Description
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.
Time Frame
Baseline, Week 6
Title
Change from Baseline in Short Form Zarit Burden Interview Score at Week 6
Description
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.
Time Frame
Baseline, Week 6
Title
Change from Baseline in DSD Caregiving Mastery Assessment Score at Week 2
Description
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.
Time Frame
Baseline, Week 2
Title
Change from Baseline in DSD Caregiving Mastery Assessment Score at Week 6
Description
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.
Time Frame
Baseline, Week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shih-Yin Lin
Phone
(720) 883-5715
Email
SL199@nyu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Yong K. Choi K. Choi
Phone
(206) 496-2147
Email
yong.choi@pitt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shih-Yin Lin
Organizational Affiliation
NYU Rory Meyers College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Study of the Aliviado DSD Caregiving Mastery Program
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