Trial Outcomes & Findings for PLAN: Dementia Literacy Education and Navigation for Korean Elders With Probable Dementia and Their Caregivers (NCT NCT03909347)
NCT ID: NCT03909347
Last Updated: 2026-08-03
Results Overview
Linkage to medical service for dementia is defined as the completion of a medical clinic visit by a Korean older adult with probable dementia.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
574 participants
Primary outcome timeframe
6 months
Results posted on
2026-08-03
Participant Flow
The study utilized remote, virtual, and in-person recruitment strategies. Recruitment efforts included social media, ethnic media, and community-based outreach at adult daycare centers, churches, and senior centers. Recruitment began February 2021. The first dyad was enrolled on April 20, 2021. Recruitment continued through January 2024.
Per protocol, participants are considered enrolled upon randomization. * 786 (393 older adults and 393 caregivers) consented. * 210 (105 dyads) were excluded prior to assignment * 184 were ineligible * 22 declined for caregiver-related reasons, * 2 declined by older adult choice, * 2 were excluded: 1 older adult died; caregiver excluded after partner's death
Participant milestones
| Measure |
PLAN (Intervention)
Group 1 will receive the study intervention during the 6 months of the study, after the first baseline questionnaire. The intervention is as follows: participants will be asked to take part in a one-time, one-hour education in participants' home or any community location that is most convenient for the participants by a trained community health worker. An educational resource that participants can read at home will be provided at the end of education session. Participants' community health worker will call the participants monthly to identify barriers to dementia care and help participants and participants' elder with making an appointment or transportation to the health care facility, when participants request for assistance.
|
Standard of Care (Control)
Group 2 will receive a signs and treatment of dementia pamphlet by the Alzheimer's Association and will be referred to the elder's primary physician.
|
|---|---|---|
|
Overall Study
STARTED
|
292
|
282
|
|
Overall Study
Patients
|
146
|
141
|
|
Overall Study
Caregivers
|
146
|
141
|
|
Overall Study
Patient-Caregiver Dyads
|
146
|
141
|
|
Overall Study
Duplicate Dyad
|
1
|
0
|
|
Overall Study
COMPLETED
|
276
|
264
|
|
Overall Study
NOT COMPLETED
|
16
|
18
|
Reasons for withdrawal
| Measure |
PLAN (Intervention)
Group 1 will receive the study intervention during the 6 months of the study, after the first baseline questionnaire. The intervention is as follows: participants will be asked to take part in a one-time, one-hour education in participants' home or any community location that is most convenient for the participants by a trained community health worker. An educational resource that participants can read at home will be provided at the end of education session. Participants' community health worker will call the participants monthly to identify barriers to dementia care and help participants and participants' elder with making an appointment or transportation to the health care facility, when participants request for assistance.
|
Standard of Care (Control)
Group 2 will receive a signs and treatment of dementia pamphlet by the Alzheimer's Association and will be referred to the elder's primary physician.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
4
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Death
|
1
|
4
|
|
Overall Study
Dyad discontinued following partner death
|
1
|
4
|
Baseline Characteristics
Patients and caregivers analyzed separately
Baseline characteristics by cohort
| Measure |
PLAN (Intervention)
n=292 Participants
Group 1 will receive the study intervention during the 6 months of the study, after the first baseline questionnaire. The intervention is as follows: participants will be asked to take part in a one-time, one-hour education in participants' home or any community location that is most convenient for the participants by a trained community health worker. An educational resource that participants can read at home will be provided at the end of education session. Participants' community health worker will call the participants monthly to identify barriers to dementia care and help participants and participants' elder with making an appointment or transportation to the health care facility, when participants request for assistance.
|
Standard of Care (Control)
n=282 Participants
Group 2 will receive a signs and treatment of dementia pamphlet by the Alzheimer's Association and will be referred to the elder's primary physician.
|
Total
n=574 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Care Recipients (Korean Older Adults)
|
82.6 years
STANDARD_DEVIATION 6.2 • n=146 Participants • Patients and caregivers analyzed separately
|
82.3 years
STANDARD_DEVIATION 6.1 • n=141 Participants • Patients and caregivers analyzed separately
|
82.5 years
STANDARD_DEVIATION 6.1 • n=287 Participants • Patients and caregivers analyzed separately
|
|
Age, Continuous
Caregivers
|
67.4 years
STANDARD_DEVIATION 13.2 • n=146 Participants • Patients and caregivers analyzed separately
|
66.4 years
STANDARD_DEVIATION 13.2 • n=141 Participants • Patients and caregivers analyzed separately
|
66.9 years
STANDARD_DEVIATION 13.2 • n=287 Participants • Patients and caregivers analyzed separately
|
|
Sex: Female, Male
Care Recipients (Korean Older Adults) · Female
|
109 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
99 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
208 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Sex: Female, Male
Care Recipients (Korean Older Adults) · Male
|
37 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
42 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
79 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Sex: Female, Male
Caregivers · Female
|
106 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
94 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
200 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Sex: Female, Male
Caregivers · Male
|
40 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
47 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
87 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Ethnicity (NIH/OMB)
Care Recipients (Korean Older Adults) · Hispanic or Latino
|
0 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Ethnicity (NIH/OMB)
Care Recipients (Korean Older Adults) · Not Hispanic or Latino
|
146 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
141 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
287 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Ethnicity (NIH/OMB)
Care Recipients (Korean Older Adults) · Unknown or Not Reported
|
0 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Ethnicity (NIH/OMB)
Caregivers · Hispanic or Latino
|
0 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Ethnicity (NIH/OMB)
Caregivers · Not Hispanic or Latino
|
146 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
141 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
287 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Ethnicity (NIH/OMB)
Caregivers · Unknown or Not Reported
|
0 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Race (NIH/OMB)
Care Recipients (Korean Older Adults) · American Indian or Alaska Native
|
0 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Race (NIH/OMB)
Care Recipients (Korean Older Adults) · Asian
|
146 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
141 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
287 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Race (NIH/OMB)
Care Recipients (Korean Older Adults) · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Race (NIH/OMB)
Care Recipients (Korean Older Adults) · Black or African American
|
0 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Race (NIH/OMB)
Care Recipients (Korean Older Adults) · White
|
0 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Race (NIH/OMB)
Care Recipients (Korean Older Adults) · More than one race
|
0 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Race (NIH/OMB)
Care Recipients (Korean Older Adults) · Unknown or Not Reported
|
0 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
|
0 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Race (NIH/OMB)
Caregivers · Asian
|
146 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
141 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
287 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Race (NIH/OMB)
Caregivers · Black or African American
|
0 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Race (NIH/OMB)
Caregivers · White
|
0 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Race (NIH/OMB)
Caregivers · More than one race
|
0 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
|
0 Participants
n=146 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=141 Participants • Patients and Caregivers analyzed separately
|
0 Participants
n=287 Participants • Patients and Caregivers analyzed separately
|
|
Region of Enrollment
United States
|
292 Participants
n=292 Participants
|
282 Participants
n=282 Participants
|
574 Participants
n=574 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Participants with data collected. Control (SOC) participants were not included in the analysis.
Linkage to medical service for dementia is defined as the completion of a medical clinic visit by a Korean older adult with probable dementia.
Outcome measures
| Measure |
PLAN (Intervention)
n=138 Participants
Group 1 will receive the study intervention during the 6 months of the study, after the first baseline questionnaire. The intervention is as follows: participants will be asked to take part in a one-time, one-hour education in participants' home or any community location that is most convenient for the participants by a trained community health worker. An educational resource that participants can read at home will be provided at the end of education session. Participants' community health worker will call the participants monthly to identify barriers to dementia care and help participants and participants' elder with making an appointment or transportation to the health care facility, when participants request for assistance.
|
Standard of Care (Control)
Group 2 will receive a signs and treatment of dementia pamphlet by the Alzheimer's Association and will be referred to the elder's primary physician.
|
|---|---|---|
|
Number of Participants Linked to Medical Service for Dementia Measured by Medical Record Verification
|
23 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 6 monthsPopulation: Caregiver participants only. Participants with data collected.
Dementia literacy test is a 11-item instrument (true or false). Scoring of the dementia literacy instrument is in such a way that each correct response will be coded as 1 whereas incorrect response will be coded as 0. Total scores can range from 0 to 11 with higher scores indicating higher health literacy.
Outcome measures
| Measure |
PLAN (Intervention)
n=146 Participants
Group 1 will receive the study intervention during the 6 months of the study, after the first baseline questionnaire. The intervention is as follows: participants will be asked to take part in a one-time, one-hour education in participants' home or any community location that is most convenient for the participants by a trained community health worker. An educational resource that participants can read at home will be provided at the end of education session. Participants' community health worker will call the participants monthly to identify barriers to dementia care and help participants and participants' elder with making an appointment or transportation to the health care facility, when participants request for assistance.
|
Standard of Care (Control)
n=141 Participants
Group 2 will receive a signs and treatment of dementia pamphlet by the Alzheimer's Association and will be referred to the elder's primary physician.
|
|---|---|---|
|
Caregiver's Dementia Literacy Measured by Dementia Literacy Test
Baseline
|
7.1 Score on a scale
Standard Deviation 1.4
|
7.0 Score on a scale
Standard Deviation 1.3
|
|
Caregiver's Dementia Literacy Measured by Dementia Literacy Test
3-month
|
7.5 Score on a scale
Standard Deviation 1.4
|
7.5 Score on a scale
Standard Deviation 1.4
|
|
Caregiver's Dementia Literacy Measured by Dementia Literacy Test
6-month
|
7.8 Score on a scale
Standard Deviation 1.3
|
7.7 Score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 6 monthsPopulation: Caregiver participants only. Participants with data collected.
Dementia self-efficacy scale is a 10-item instrument. Scoring of the dementia self-efficacy scale ranges from "not at all certain" coded as 1 to "very certain" coded as 10 for each item. Total scores will range from 10 to 100 with higher scores indicating higher self-efficacy.
Outcome measures
| Measure |
PLAN (Intervention)
n=146 Participants
Group 1 will receive the study intervention during the 6 months of the study, after the first baseline questionnaire. The intervention is as follows: participants will be asked to take part in a one-time, one-hour education in participants' home or any community location that is most convenient for the participants by a trained community health worker. An educational resource that participants can read at home will be provided at the end of education session. Participants' community health worker will call the participants monthly to identify barriers to dementia care and help participants and participants' elder with making an appointment or transportation to the health care facility, when participants request for assistance.
|
Standard of Care (Control)
n=141 Participants
Group 2 will receive a signs and treatment of dementia pamphlet by the Alzheimer's Association and will be referred to the elder's primary physician.
|
|---|---|---|
|
Self-efficacy in Dementia Care Measured by Dementia Self-efficacy Scale
Baseline
|
54.4 Score on a scale
Standard Deviation 15.1
|
52.7 Score on a scale
Standard Deviation 15.6
|
|
Self-efficacy in Dementia Care Measured by Dementia Self-efficacy Scale
3-month
|
56.8 Score on a scale
Standard Deviation 14.4
|
58.8 Score on a scale
Standard Deviation 14.8
|
|
Self-efficacy in Dementia Care Measured by Dementia Self-efficacy Scale
6-month
|
59.7 Score on a scale
Standard Deviation 15.2
|
59.8 Score on a scale
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 6 monthsPopulation: Caregiver participants only. Participants with data collected.
The 8-item scale of medical outcomes study scoring ranges from "none of the time" coded as 1 to "all of the time" coded as 5 for each item. Mean scores will range from 1 to 5, with higher scores indicating greater social support.
Outcome measures
| Measure |
PLAN (Intervention)
n=146 Participants
Group 1 will receive the study intervention during the 6 months of the study, after the first baseline questionnaire. The intervention is as follows: participants will be asked to take part in a one-time, one-hour education in participants' home or any community location that is most convenient for the participants by a trained community health worker. An educational resource that participants can read at home will be provided at the end of education session. Participants' community health worker will call the participants monthly to identify barriers to dementia care and help participants and participants' elder with making an appointment or transportation to the health care facility, when participants request for assistance.
|
Standard of Care (Control)
n=141 Participants
Group 2 will receive a signs and treatment of dementia pamphlet by the Alzheimer's Association and will be referred to the elder's primary physician.
|
|---|---|---|
|
Social Support Status as Assessed by Medical Outcomes Study Scale
Baseline
|
3.7 score on a scale
Standard Deviation 1.1
|
3.7 score on a scale
Standard Deviation 1.1
|
|
Social Support Status as Assessed by Medical Outcomes Study Scale
3-month
|
3.6 score on a scale
Standard Deviation 1.1
|
3.7 score on a scale
Standard Deviation 1.1
|
|
Social Support Status as Assessed by Medical Outcomes Study Scale
6-month
|
3.7 score on a scale
Standard Deviation 1.1
|
3.8 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, 3 months, and 6 monthsPopulation: Caregiver participants only. Participants with data collected.
Patient health questionnaire-9 is a 9-item instrument and scoring ranges from "not at all" coded as 0 to "nearly every day" coded as 3. Total scores will range from 0 to 27 with higher score indicating higher depression.
Outcome measures
| Measure |
PLAN (Intervention)
n=146 Participants
Group 1 will receive the study intervention during the 6 months of the study, after the first baseline questionnaire. The intervention is as follows: participants will be asked to take part in a one-time, one-hour education in participants' home or any community location that is most convenient for the participants by a trained community health worker. An educational resource that participants can read at home will be provided at the end of education session. Participants' community health worker will call the participants monthly to identify barriers to dementia care and help participants and participants' elder with making an appointment or transportation to the health care facility, when participants request for assistance.
|
Standard of Care (Control)
n=141 Participants
Group 2 will receive a signs and treatment of dementia pamphlet by the Alzheimer's Association and will be referred to the elder's primary physician.
|
|---|---|---|
|
Depression Status as Assessed by Patient Health Questionnaire-9
Baseline
|
1.9 score on a scale
Standard Deviation 2.1
|
1.9 score on a scale
Standard Deviation 1.8
|
|
Depression Status as Assessed by Patient Health Questionnaire-9
3-month
|
1.7 score on a scale
Standard Deviation 1.9
|
1.8 score on a scale
Standard Deviation 2.0
|
|
Depression Status as Assessed by Patient Health Questionnaire-9
6-month
|
1.7 score on a scale
Standard Deviation 1.9
|
1.7 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Caregiver participants only. Participants with data collected.
QoL-dementia caregiver is a 13-item instrument and scoring ranges from "poor" coded as 1 to "excellent" coded as 4 for each item. Total scores will range from 13 to 52 with higher scores indicating higher quality of life.
Outcome measures
| Measure |
PLAN (Intervention)
n=146 Participants
Group 1 will receive the study intervention during the 6 months of the study, after the first baseline questionnaire. The intervention is as follows: participants will be asked to take part in a one-time, one-hour education in participants' home or any community location that is most convenient for the participants by a trained community health worker. An educational resource that participants can read at home will be provided at the end of education session. Participants' community health worker will call the participants monthly to identify barriers to dementia care and help participants and participants' elder with making an appointment or transportation to the health care facility, when participants request for assistance.
|
Standard of Care (Control)
n=141 Participants
Group 2 will receive a signs and treatment of dementia pamphlet by the Alzheimer's Association and will be referred to the elder's primary physician.
|
|---|---|---|
|
Quality of Life (QoL) Measured by QoL-dementia Caregiver Instrument
Baseline
|
35.3 score on a scale
Standard Deviation 5.9
|
34.5 score on a scale
Standard Deviation 6.0
|
|
Quality of Life (QoL) Measured by QoL-dementia Caregiver Instrument
3-month
|
35.5 score on a scale
Standard Deviation 6.1
|
35.4 score on a scale
Standard Deviation 6.4
|
|
Quality of Life (QoL) Measured by QoL-dementia Caregiver Instrument
6-month
|
35.6 score on a scale
Standard Deviation 6.5
|
35.5 score on a scale
Standard Deviation 6.3
|
Adverse Events
PLAN (Intervention - Caregiver)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PLAN (Intervention - Older Adult)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Standard of Care (Control-Caregiver)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Standard or Care (Control-Older Adult)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PLAN (Intervention - Caregiver)
n=146 participants at risk
Group 1 will receive the study intervention during the 6 months of the study, after the first baseline questionnaire. The intervention is as follows: participants will be asked to take part in a one-time, one-hour education in participants' home or any community location that is most convenient for the participants by a trained community health worker. An educational resource that participants can read at home will be provided at the end of education session. Participants' community health worker will call the participants monthly to identify barriers to dementia care and help participants and participants' elder with making an appointment or transportation to the health care facility, when participants request for assistance.
|
PLAN (Intervention - Older Adult)
n=146 participants at risk
Group 1 will receive the study intervention during the 6 months of the study, after the first baseline questionnaire. The intervention is as follows: participants, who are caregivers, will be asked to take part in a one-time, one-hour education in participants' home or any community location that is most convenient for the participants by a trained community health worker. An educational resource that participants can read at home will be provided at the end of education session. Participants' community health worker will call the participants monthly to identify barriers to dementia care and help participants and participants' elder with making an appointment or transportation to the health care facility, when participants request for assistance.
|
Standard of Care (Control-Caregiver)
n=141 participants at risk
Group 2 will receive a signs and treatment of dementia pamphlet by the Alzheimer's Association and will be referred to the elder's primary physician.
|
Standard or Care (Control-Older Adult)
n=141 participants at risk
Group 2 will receive a signs and treatment of dementia pamphlet by the Alzheimer's Association and will be referred to the elder's primary physician.
|
|---|---|---|---|---|
|
Psychiatric disorders
Anxiety
|
2.1%
3/146 • From enrollment up to 6-months followup
The measures were based on self-report. Adverse events were defined based on symptom thresholds using the PHQ-9 and GAD-2. Events were identified using three criteria: (1) anxiety defined as GAD-2 score ≥ 3, (2) suicidal ideation defined as PHQ-9 item 9 score \> 0, and (3) co-occurrence of anxiety and suicidal ideation. There was one caregiver death and four older adult deaths. In Participant Flow, deaths were reported by dyad.
|
0.00%
0/146 • From enrollment up to 6-months followup
The measures were based on self-report. Adverse events were defined based on symptom thresholds using the PHQ-9 and GAD-2. Events were identified using three criteria: (1) anxiety defined as GAD-2 score ≥ 3, (2) suicidal ideation defined as PHQ-9 item 9 score \> 0, and (3) co-occurrence of anxiety and suicidal ideation. There was one caregiver death and four older adult deaths. In Participant Flow, deaths were reported by dyad.
|
1.4%
2/141 • From enrollment up to 6-months followup
The measures were based on self-report. Adverse events were defined based on symptom thresholds using the PHQ-9 and GAD-2. Events were identified using three criteria: (1) anxiety defined as GAD-2 score ≥ 3, (2) suicidal ideation defined as PHQ-9 item 9 score \> 0, and (3) co-occurrence of anxiety and suicidal ideation. There was one caregiver death and four older adult deaths. In Participant Flow, deaths were reported by dyad.
|
0.00%
0/141 • From enrollment up to 6-months followup
The measures were based on self-report. Adverse events were defined based on symptom thresholds using the PHQ-9 and GAD-2. Events were identified using three criteria: (1) anxiety defined as GAD-2 score ≥ 3, (2) suicidal ideation defined as PHQ-9 item 9 score \> 0, and (3) co-occurrence of anxiety and suicidal ideation. There was one caregiver death and four older adult deaths. In Participant Flow, deaths were reported by dyad.
|
|
Psychiatric disorders
Self-reported suicidal ideation (PHQ-9 item 9 > 0)
|
4.1%
6/146 • From enrollment up to 6-months followup
The measures were based on self-report. Adverse events were defined based on symptom thresholds using the PHQ-9 and GAD-2. Events were identified using three criteria: (1) anxiety defined as GAD-2 score ≥ 3, (2) suicidal ideation defined as PHQ-9 item 9 score \> 0, and (3) co-occurrence of anxiety and suicidal ideation. There was one caregiver death and four older adult deaths. In Participant Flow, deaths were reported by dyad.
|
0.00%
0/146 • From enrollment up to 6-months followup
The measures were based on self-report. Adverse events were defined based on symptom thresholds using the PHQ-9 and GAD-2. Events were identified using three criteria: (1) anxiety defined as GAD-2 score ≥ 3, (2) suicidal ideation defined as PHQ-9 item 9 score \> 0, and (3) co-occurrence of anxiety and suicidal ideation. There was one caregiver death and four older adult deaths. In Participant Flow, deaths were reported by dyad.
|
0.71%
1/141 • From enrollment up to 6-months followup
The measures were based on self-report. Adverse events were defined based on symptom thresholds using the PHQ-9 and GAD-2. Events were identified using three criteria: (1) anxiety defined as GAD-2 score ≥ 3, (2) suicidal ideation defined as PHQ-9 item 9 score \> 0, and (3) co-occurrence of anxiety and suicidal ideation. There was one caregiver death and four older adult deaths. In Participant Flow, deaths were reported by dyad.
|
0.00%
0/141 • From enrollment up to 6-months followup
The measures were based on self-report. Adverse events were defined based on symptom thresholds using the PHQ-9 and GAD-2. Events were identified using three criteria: (1) anxiety defined as GAD-2 score ≥ 3, (2) suicidal ideation defined as PHQ-9 item 9 score \> 0, and (3) co-occurrence of anxiety and suicidal ideation. There was one caregiver death and four older adult deaths. In Participant Flow, deaths were reported by dyad.
|
|
Psychiatric disorders
Co-occurrence of anxiety (GAD-2 ≥ 3) and suicidal ideation (PHQ-9 item 9 > 0)
|
0.68%
1/146 • From enrollment up to 6-months followup
The measures were based on self-report. Adverse events were defined based on symptom thresholds using the PHQ-9 and GAD-2. Events were identified using three criteria: (1) anxiety defined as GAD-2 score ≥ 3, (2) suicidal ideation defined as PHQ-9 item 9 score \> 0, and (3) co-occurrence of anxiety and suicidal ideation. There was one caregiver death and four older adult deaths. In Participant Flow, deaths were reported by dyad.
|
0.00%
0/146 • From enrollment up to 6-months followup
The measures were based on self-report. Adverse events were defined based on symptom thresholds using the PHQ-9 and GAD-2. Events were identified using three criteria: (1) anxiety defined as GAD-2 score ≥ 3, (2) suicidal ideation defined as PHQ-9 item 9 score \> 0, and (3) co-occurrence of anxiety and suicidal ideation. There was one caregiver death and four older adult deaths. In Participant Flow, deaths were reported by dyad.
|
0.00%
0/141 • From enrollment up to 6-months followup
The measures were based on self-report. Adverse events were defined based on symptom thresholds using the PHQ-9 and GAD-2. Events were identified using three criteria: (1) anxiety defined as GAD-2 score ≥ 3, (2) suicidal ideation defined as PHQ-9 item 9 score \> 0, and (3) co-occurrence of anxiety and suicidal ideation. There was one caregiver death and four older adult deaths. In Participant Flow, deaths were reported by dyad.
|
0.00%
0/141 • From enrollment up to 6-months followup
The measures were based on self-report. Adverse events were defined based on symptom thresholds using the PHQ-9 and GAD-2. Events were identified using three criteria: (1) anxiety defined as GAD-2 score ≥ 3, (2) suicidal ideation defined as PHQ-9 item 9 score \> 0, and (3) co-occurrence of anxiety and suicidal ideation. There was one caregiver death and four older adult deaths. In Participant Flow, deaths were reported by dyad.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place