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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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 family caregivers of PLWD at high risk for delirium, assessing feasibility, acceptability, app usability, and preliminary program impact (Aim 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Family Caregivers of PLWD at High Risk for Delirium | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliviado DSD Caregiving Mastery Program | Behavioral | 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. |
| 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: Satisfaction | 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. | Week 6 |
| Program Satisfaction Questionnaire Score: Intention to Change | 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. | 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. |
| 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 |
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Inclusion Criteria:
To be eligible as a "dementia caregiver" in the co-design workshop, an individual must:
To be eligible as a "DSD caregiver" in the co-design workshop, an individual must:
To be eligible to participate in the feasibility trial, an individual must meet all of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shih-Yin Lin | NYU Rory Meyers College of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10010 | United States | ||
| University of Pittsburgh |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of the 32 consented primary family caregivers, 2 did not meet the eligibility criteria and were excluded from all data analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Complete the Study | Measure of feasibility. Feasibility indicated by retention rate of 85%. | All eligible enrolled primary family caregivers (n = 30) were analyzed. | Posted | Count of Participants | Participants | Week 6 |
|
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Room Visit | Musculoskeletal and connective tissue disorders | Systematic Assessment | The caregiver had an overnight ER visit because she tore a ligament in her hip while lifting. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shih-Yin Lin | NYU Langone Health | (720) 883-571 | SL199@nyu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 28, 2024 | Jan 5, 2026 | Prot_SAP_000.pdf |
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| Up to Week 6 |
| Modified IBM Computer Usability Satisfaction Questionnaire Score | 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. | Up to Week 6 |
| 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 (Competence) at Week 2 | 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. | Baseline, Week 2 |
| Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at Week 6 | 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. | Baseline, Week 6 |
| Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 2 | 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. | Baseline, Week 2 |
| Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 6 | 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. | Baseline, Week 6 |
| Pittsburgh |
| Pennsylvania |
| 15260 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Program Satisfaction Questionnaire Score: Satisfaction | 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. | 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. | Posted | Count of Participants | Participants | Week 6 |
|
|
|
| Primary | Program Satisfaction Questionnaire Score: Intention to Change | 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. | 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. | Posted | Count of Participants | Participants | Week 6 |
|
|
|
| Primary | Number of Participants Who Complete All Training Videos by Week 2 | Measure of acceptability. | 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. | Posted | Count of Participants | Participants | Up to Week 2 |
|
|
|
| Primary | Number of Participants Who Complete Weekly Delirium Screening at Least Twice by Week 6 | Measure of acceptability. | 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. | Posted | Count of Participants | Participants | Up to Week 6 |
|
|
|
| Primary | Modified IBM Computer Usability Satisfaction Questionnaire Score | 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. | Eligible primary caregivers who completed both the baseline and Week 6 assessments (n = 26) were included in the analysis. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Eligible primary caregivers who completed both the baseline and Week 6 assessments (n = 26) were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 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. | Eligible primary caregivers who completed both the baseline and Week 6 assessments (n = 26) were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
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|
| 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. | Eligible primary caregivers who completed both the baseline and Week 6 assessments (n = 26) were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
|
|
|
| Secondary | Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at Week 2 | 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. | Eligible Primary caregivers who completed both the baseline and Week 2 assessments (n = 29) were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 2 |
|
|
|
| Secondary | Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at Week 6 | 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. | Eligible primary caregivers who completed both the baseline and Week 6 assessments (n = 26) were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
|
|
|
| Secondary | Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 2 | 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. | Eligible Primary caregivers who completed both the baseline and Week 2 assessments (n = 29) were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 2 |
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|
| Secondary | Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 6 | 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. | Eligible primary caregivers who completed both the baseline and Week 6 assessments (n = 26) were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 6 |
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|
|
| 0 |
| 26 |
| 1 |
| 26 |
| 4 |
| 26 |
|
| Sinus infection | Infections and infestations | Systematic Assessment |
|
| Increased physical symptoms | Infections and infestations | Systematic Assessment | Increased physical symptoms and feeling under the weather, likely cold symptoms. |
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| Soreness and aches | Musculoskeletal and connective tissue disorders | Systematic Assessment | Arm soreness and hip and leg aches due to lifting the care recipient after a fall. |
|
| Migraines | Nervous system disorders | Systematic Assessment |
|
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