Study of the Aliviado DSD Caregiving Mastery Program
- Conditions
- Delirium Superimposed on Dementia
- Interventions
- Behavioral: Aliviado DSD Caregiving Mastery Program
- Registration Number
- NCT05630014
- Lead Sponsor
- NYU Langone Health
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
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.
- Individuals who are blind or deaf will be excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Family Caregivers of PLWD at High Risk for Delirium Aliviado DSD Caregiving Mastery Program 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.
- Primary Outcome Measures
Name Time Method Modified IBM Computer Usability Satisfaction Questionnaire Score Week 6 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.
Number of Participants who Complete all Training Videos by Week 2 Up to Week 2 Measure of acceptability.
Number of Participants who Complete Weekly Delirium Screening at Least Twice by Week 6 Up to Week 6 Measure of acceptability.
Number of Participants who Complete the Study Week 6 Measure of feasibility. Feasibility indicated by retention rate of 85%.
Program Satisfaction Questionnaire Score Week 6 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 2 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.
Change from Baseline in Center for Epidemiological Studies Depression Scale (CES-D) Score at Week 6 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.
Change from Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 6 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.
Change from Baseline in DSD Caregiving Mastery Assessment Score at Week 6 Baseline, 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.
Change from Baseline in Modified Caregiver Strain Index Score at Week 6 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.
Change from Baseline in Short Form Zarit Burden Interview Score at Week 6 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.
Change from Baseline in DSD Caregiving Mastery Assessment Score at Week 2 Baseline, 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.
Trial Locations
- Locations (2)
NYU Langone Health
🇺🇸New York, New York, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States