Study of the Aliviado DSD Caregiving Mastery Program

Study Overview
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Brief Summary
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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).

Official Title
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Development and Piloting of a Family-Centered, mHealth-Enhanced Intervention to Promote Caregiving Mastery in Detection, Prevention, and Management of Delirium Superimposed on Dementia

Conditions
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Delirium Superimposed on Dementia

Intervention / Treatment
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* Behavioral: Aliviado DSD Caregiving Mastery Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Caregivers of PLWD at High Risk for Delirium<br>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. | Behavioral: Aliviado DSD Caregiving Mastery Program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants who Complete the Study | Measure of feasibility. Feasibility indicated by retention rate of 85%. | Week 6 | 
| 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 | 
| 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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |