Delirium Superimposed on Dementia
Conditions
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 family caregivers of PLWD at high risk for delirium, assessing feasibility, acceptability, app usability, and preliminary program impact (Aim 2).
Interventions
BEHAVIORALAliviado 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.
Sponsors
NYU Langone Health
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Complete the Study | Week 6 | Measure of feasibility. Feasibility indicated by retention rate of 85%. |
| Program Satisfaction Questionnaire Score: Satisfaction | Week 6 | 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. |
| Program Satisfaction Questionnaire Score: Intention to Change | Week 6 | 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. |
| 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. |
| Modified IBM Computer Usability Satisfaction Questionnaire Score | Up to Week 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 (Competence) at Week 2 | Baseline, 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. |
| Change From Baseline in DSD Caregiving Mastery Assessment Score (Competence) at Week 6 | Baseline, 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. |
| Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 2 | Baseline, 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. |
| Change From Baseline in DSD Caregiving Mastery Assessment Score (Self-Efficacy) at Week 6 | Baseline, 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORShih-Yin Lin
NYU Rory Meyers College of Nursing
Participant flow
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 58.3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 4 / 26 |
| serious Total, serious adverse events | 1 / 26 |
Outcome results
None listed