Trial Outcomes & Findings for Study of the Aliviado DSD Caregiving Mastery Program (NCT NCT05630014)
NCT ID: NCT05630014
Last Updated: 2026-02-10
Results Overview
Measure of feasibility. Feasibility indicated by retention rate of 85%.
COMPLETED
NA
33 participants
Week 6
2026-02-10
Participant Flow
Focus Groups were conducted in Aim 1 with 8 family caregivers to develop the program. These participants were not considered enrolled for the purposes of this study.
Participant milestones
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
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.
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.
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Overall Study
STARTED
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32
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Overall Study
COMPLETED
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26
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Overall Study
NOT COMPLETED
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6
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Reasons for withdrawal
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
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.
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.
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Overall Study
Lost to Follow-up
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1
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Overall Study
Withdrawal by Subject
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3
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Overall Study
Physician Decision
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2
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Baseline Characteristics
Study of the Aliviado DSD Caregiving Mastery Program
Baseline characteristics by cohort
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=30 Participants
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.
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.
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Region of Enrollment
United States
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30 participants
n=41 Participants
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Age, Continuous
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58.3 years
n=41 Participants
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Sex: Female, Male
Female
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25 Participants
n=41 Participants
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Sex: Female, Male
Male
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5 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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27 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=41 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=41 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Black or African American
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9 Participants
n=41 Participants
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Race (NIH/OMB)
White
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20 Participants
n=41 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=41 Participants
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PRIMARY outcome
Timeframe: Week 6Population: All eligible enrolled primary family caregivers (n = 30) were analyzed.
Measure of feasibility. Feasibility indicated by retention rate of 85%.
Outcome measures
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=30 Participants
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.
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.
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Number of Participants Who Complete the Study
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26 Participants
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PRIMARY outcome
Timeframe: Week 6Population: All eligible primary caregivers who completed the study and the program satisfaction questionnaire (n = 26) were included in the analysis. One primary caregiver had a missing response on one Likert-type item; therefore, the total program satisfaction score was calculated as the average of the 11 completed Likert-type items multiplied by 12.
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.
Outcome measures
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=26 Participants
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.
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.
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Program Satisfaction Questionnaire Score: Satisfaction
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26 Participants
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PRIMARY outcome
Timeframe: Week 6Population: All eligible primary caregivers who completed the study and the intention-to-change question on the program satisfaction questionnaire (n = 26) were included in the analysis.
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.
Outcome measures
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=26 Participants
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.
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.
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Program Satisfaction Questionnaire Score: Intention to Change
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26 Participants
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PRIMARY outcome
Timeframe: Up to Week 2Population: All eligible enrolled primary family caregivers (n = 30) were analyzed. One caregiver refused to complete the training videos and subsequently declined continued participation in the study.
Measure of acceptability.
Outcome measures
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=30 Participants
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.
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.
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Number of Participants Who Complete All Training Videos by Week 2
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29 Participants
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PRIMARY outcome
Timeframe: Up to Week 6Population: All eligible enrolled primary family caregivers who completed the study (n = 26) were analyzed. Four eligible primary family caregivers dropped out of the study (n=3) or were lost to follow-up (n=1) before Week 6 and were excluded from the analysis.
Measure of acceptability.
Outcome measures
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=26 Participants
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.
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.
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Number of Participants Who Complete Weekly Delirium Screening at Least Twice by Week 6
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26 Participants
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PRIMARY outcome
Timeframe: Up to Week 6Population: Eligible primary caregivers who completed both the baseline and Week 6 assessments (n = 26) were included in the analysis.
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.
Outcome measures
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=26 Participants
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.
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.
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Modified IBM Computer Usability Satisfaction Questionnaire Score
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4.41 score on a scale
Interval 3.9 to 4.7
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SECONDARY outcome
Timeframe: Baseline, Week 2Population: Of the 33 enrolled caregivers, 29 eligible primary caregivers were included for analysis. Of the 4 excluded caregivers, 2 did not meet study eligibility, 1 was a secondary caregiver, and 1 primary caregiver withdrew before completing the Week 2 Caregiver Delirium Knowledge Questionnaire.
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.
Outcome measures
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=29 Participants
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.
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.
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Change From Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 2
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3.86 score on a scale
Standard Deviation 3.61
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SECONDARY outcome
Timeframe: Baseline, Week 6Population: Eligible primary caregivers who completed both the baseline and Week 6 assessments (n = 26) were included in the analysis.
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.
Outcome measures
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=26 Participants
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.
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.
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Change From Baseline in Caregiver Delirium Knowledge Questionnaire Score at Week 6
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3.81 score on a scale
Standard Deviation 3.57
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SECONDARY outcome
Timeframe: Baseline, Week 6Population: Eligible primary caregivers who completed both the baseline and Week 6 assessments (n = 26) were included in the analysis.
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.
Outcome measures
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=26 Participants
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.
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.
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Change From Baseline in Modified Caregiver Strain Index Score at Week 6
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0.04 score on a scale
Standard Deviation 10.74
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SECONDARY outcome
Timeframe: Baseline, Week 6Population: Eligible primary caregivers who completed both the baseline and Week 6 assessments (n = 26) were included in the analysis. One caregiver had two missing values in the baseline assessment; therefore, the total baseline CES-D score for this caregiver was calculated as the average of the sum of the 18 answered items multiplied by 20.
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.
Outcome measures
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=26 Participants
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.
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.
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Change From Baseline in Center for Epidemiological Studies Depression Scale (CES-D) Score at Week 6
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-2.15 score on a scale
Standard Deviation 6.66
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SECONDARY outcome
Timeframe: Baseline, Week 6Population: Eligible primary caregivers who completed both the baseline and Week 6 assessments (n = 26) were included in the analysis.
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.
Outcome measures
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=26 Participants
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.
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.
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Change From Baseline in Short Form Zarit Burden Interview Score at Week 6
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-2.15 score on a scale
Standard Deviation 4.82
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SECONDARY outcome
Timeframe: Baseline, Week 2Population: Eligible Primary caregivers who completed both the baseline and Week 2 assessments (n = 29) were included in the analysis.
4-item DSD Competence Scale modified from Pearline's Competence Scale. Each item is rated on a scale from 1-4. The total score is the sum of responses and ranges from 4 to 16. Higher scores indicate greater levels of mastery.
Outcome measures
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=29 Participants
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.
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.
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Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at Week 2
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1.62 score on a scale
Standard Deviation 2.87
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SECONDARY outcome
Timeframe: Baseline, Week 6Population: Eligible primary caregivers who completed both the baseline and Week 6 assessments (n = 26) were included in the analysis.
4-item DSD Competence Scale modified from Pearline's Competence Scale. Each item is rated on a scale from 1-4. The total score is the sum of responses and ranges from 4 to 16. Higher scores indicate greater levels of mastery.
Outcome measures
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=26 Participants
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.
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.
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Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at Week 6
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2.73 score on a scale
Standard Deviation 3.38
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SECONDARY outcome
Timeframe: Baseline, Week 2Population: Eligible Primary caregivers who completed both the baseline and Week 2 assessments (n = 29) were included in the analysis.
25-item DSD self-efficacy scale developed by the Aliviado team to assess confidence of DSD prevention, detection, and management tasks. Each item is rated on a scale from 0-100. The total score is the average of sum of non-missing responses and ranges from 0 to 100. Higher scores indicate greater levels of mastery.
Outcome measures
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=29 Participants
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.
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.
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Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 2
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3.59 score on a scale
Standard Deviation 10.1
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SECONDARY outcome
Timeframe: Baseline, Week 6Population: Eligible primary caregivers who completed both the baseline and Week 6 assessments (n = 26) were included in the analysis.
25-item DSD self-efficacy scale developed by the Aliviado team to assess confidence of DSD prevention, detection, and management tasks. Each item is rated on a scale from 0-100. The total score is the average of sum of non-missing responses and ranges from 0 to 100. Higher scores indicate greater levels of mastery.
Outcome measures
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=26 Participants
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.
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.
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Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 6
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6.6 score on a scale
Standard Deviation 10.17
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Adverse Events
Family Caregivers of PLWD at High Risk for Delirium
Serious adverse events
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=26 participants at risk
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.
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.
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Musculoskeletal and connective tissue disorders
Emergency Room Visit
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3.8%
1/26 • Week 7 (Up to 30 Days Post-Study Completion).
Systematic: All AEs and SAEs were based on caregiver reports in response to questions on standard AE and SAE forms. Non-systematic: Caregivers were encouraged to report any additional AEs and SAEs to the study team for up to 30 days post-completion.
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Other adverse events
| Measure |
Family Caregivers of PLWD at High Risk for Delirium
n=26 participants at risk
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.
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.
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Infections and infestations
Sinus infection
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3.8%
1/26 • Week 7 (Up to 30 Days Post-Study Completion).
Systematic: All AEs and SAEs were based on caregiver reports in response to questions on standard AE and SAE forms. Non-systematic: Caregivers were encouraged to report any additional AEs and SAEs to the study team for up to 30 days post-completion.
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Infections and infestations
Increased physical symptoms
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3.8%
1/26 • Week 7 (Up to 30 Days Post-Study Completion).
Systematic: All AEs and SAEs were based on caregiver reports in response to questions on standard AE and SAE forms. Non-systematic: Caregivers were encouraged to report any additional AEs and SAEs to the study team for up to 30 days post-completion.
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Musculoskeletal and connective tissue disorders
Soreness and aches
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3.8%
1/26 • Week 7 (Up to 30 Days Post-Study Completion).
Systematic: All AEs and SAEs were based on caregiver reports in response to questions on standard AE and SAE forms. Non-systematic: Caregivers were encouraged to report any additional AEs and SAEs to the study team for up to 30 days post-completion.
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Nervous system disorders
Migraines
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3.8%
1/26 • Week 7 (Up to 30 Days Post-Study Completion).
Systematic: All AEs and SAEs were based on caregiver reports in response to questions on standard AE and SAE forms. Non-systematic: Caregivers were encouraged to report any additional AEs and SAEs to the study team for up to 30 days post-completion.
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Infections and infestations
Fever
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3.8%
1/26 • Week 7 (Up to 30 Days Post-Study Completion).
Systematic: All AEs and SAEs were based on caregiver reports in response to questions on standard AE and SAE forms. Non-systematic: Caregivers were encouraged to report any additional AEs and SAEs to the study team for up to 30 days post-completion.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place