Trial Outcomes & Findings for Adapting and Implementing the I-HoME Intervention in Caregivers of Patients With ADRD (NCT NCT06488157)

NCT ID: NCT06488157

Last Updated: 2025-08-27

Results Overview

Feasibility was measured by the percentage of caregivers who enrolled in the study out of all eligible participants.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

Recruitment (7 months)

Results posted on

2025-08-27

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention (I-HoME) Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs. I-HoME: Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adapting and Implementing the I-HoME Intervention in Caregivers of Patients With ADRD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention (I-HoME) n=15 Participants Participants receive video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs. I-HoME: Video visits with a nurse practitioner for up to six visits every 2 weeks to address symptom management and care needs
Age, Continuous	68.1 years STANDARD_DEVIATION 12.93 • n=99 Participants
Sex: Female, Male Female	9 Participants n=99 Participants
Sex: Female, Male Male	6 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	10 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	15 Participants n=99 Participants
Highest Education Completed Some high school	0 Participants n=99 Participants
Highest Education Completed High School or GED	0 Participants n=99 Participants
Highest Education Completed Some College	2 Participants n=99 Participants
Highest Education Completed College degree	1 Participants n=99 Participants
Highest Education Completed Post-graduate but no degree	0 Participants n=99 Participants
Highest Education Completed Graduate Degree	12 Participants n=99 Participants
Annual Household Income Range $25,000 or less	0 Participants n=99 Participants
Annual Household Income Range $25,001 to $50,000	1 Participants n=99 Participants
Annual Household Income Range $50,001 to $75,000	2 Participants n=99 Participants
Annual Household Income Range $75,001 or greater	12 Participants n=99 Participants
Relationship to Patient Spouse/partner	4 Participants n=99 Participants
Relationship to Patient Child	10 Participants n=99 Participants
Relationship to Patient Relative	1 Participants n=99 Participants
Relationship to Patient Friend	0 Participants n=99 Participants
Relationship to Patient Paid Caregiver	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: Recruitment (7 months)

Population: All participants who we reached out to and were eligible for our study, including those who refused to participate or were unreachable over multiple attempts, were included in the number of participants analyzed for this measure.

Feasibility was measured by the percentage of caregivers who enrolled in the study out of all eligible participants.

Outcome measures

Outcome measures
Measure	All Participants n=41 Participants This measure represents the recruitment rate for all participants.
Feasibility, as Measured by the Percentage of Caregivers Who Enroll in the Study	37 percentage of all eligible participants

PRIMARY outcome

Timeframe: At the end of the intervention or at 12 weeks, whichever is earlier

Feasibility was measured by dividing the number of tele-visits conducted by the number of tele-visits that could have been conducted, then multiplying by 100. This measure shows the adherence of the intervention arm to the tele-visits. The percentage is calculated for the group rather than the individual patient.

Outcome measures

Outcome measures
Measure	All Participants n=90 Tele-visits This measure represents the recruitment rate for all participants.
Feasibility, as Measured by the Percentage of Tele-visits Conducted	95.5 percentage of tele-visits conducted

SECONDARY outcome

Timeframe: Baseline, 2, 4, 6, 8, 10, 12 weeks

Population: This measure was not collected because, after completing the first phase of the study, we found it was not relevant to the participants in the clinical trial.

Change in behavioral and psychosocial symptoms of dementia (BPSD) in the patient, as measured by the Neuropsychiatric Inventory Questionnaire. Scale is from 0 to 36, with higher scores indicating more severe BPSD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 2, 4, 6, 8, 10, 12 week

Population: The number of participants analyzed at each time point varied because: A caregiver was ineligible to participate due to their care recipient passing away. A caregiver missed the tele-visit session on that particular week.

Mean caregiver depression score, as measured by Patient Health Questionnaire-8. Scale is from 0 to 24, with higher scores indicating more severe depression.

Outcome measures

Outcome measures
Measure	All Participants n=15 Participants This measure represents the recruitment rate for all participants.
Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8 Baseline	4.8 score on a scale Standard Deviation 3.03
Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8 Week 2	4.5 score on a scale Standard Deviation 2.77
Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8 Week 4	3.3 score on a scale Standard Deviation 2.70
Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8 Week 6	3.4 score on a scale Standard Deviation 3.38
Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8 Week 8	3.6 score on a scale Standard Deviation 3.15
Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8 Week 10	4.5 score on a scale Standard Deviation 3.74
Mean Caregiver Depression Score, as Measured by Patient Health Questionnaire-8 Week 12	3.5 score on a scale Standard Deviation 2.10

SECONDARY outcome

Timeframe: Baseline, 2, 4, 6, 8, 10, 12 weeks

Mean caregiver anxiety score, as measured by General Anxiety Disorder-7. Scale is from 0 to 21, with higher scores indicating more severe anxiety.

Outcome measures

Outcome measures
Measure	All Participants n=15 Participants This measure represents the recruitment rate for all participants.
Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7 Baseline	5.9 score on a scale Standard Deviation 3.25
Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7 Week 2	5.0 score on a scale Standard Deviation 4.17
Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7 Week 4	4.3 score on a scale Standard Deviation 3.77
Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7 Week 6	3.9 score on a scale Standard Deviation 3.96
Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7 Week 8	4.7 score on a scale Standard Deviation 4.94
Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7 Week 10	5.0 score on a scale Standard Deviation 4.49
Mean Caregiver Anxiety Score, as Measured by General Anxiety Disorder-7 Week 12	3.4 score on a scale Standard Deviation 3.33

SECONDARY outcome

Timeframe: Baseline, 2, 4, 6, 8, 10, 12 weeks

Mean caregiver burden score, as measured by the Zarit Burden Interview - short version. Scale is from 0 to 48, with higher scores indicating higher caregiver burden.

Outcome measures

Outcome measures
Measure	All Participants n=15 Participants This measure represents the recruitment rate for all participants.
Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version Baseline	16.6 score on a scale Standard Deviation 6.54
Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version Week 2	12.1 score on a scale Standard Deviation 7.43
Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version Week 4	10.1 score on a scale Standard Deviation 5.90
Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version Week 6	9.7 score on a scale Standard Deviation 6.17
Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version Week 8	9.6 score on a scale Standard Deviation 7.02
Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version Week 10	10.6 score on a scale Standard Deviation 6.33
Mean Caregiver Burden Score, as Measured by the Zarit Burden Interview - Short Version Week 12	10.6 score on a scale Standard Deviation 7.00

SECONDARY outcome

Timeframe: Baseline, 2, 4, 6, 8, 10, 12 weeks

Mean caregiver perception of patient's pain score, as measured by the Doloplus 2 Scale behavioral assessment. Scale is from 0 to 30, with higher scores indicating greater pain.

Outcome measures

Outcome measures
Measure	All Participants n=15 Participants This measure represents the recruitment rate for all participants.
Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment Week 10	4.4 score on a scale Standard Deviation 4.62
Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment Baseline	5.1 score on a scale Standard Deviation 3.99
Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment Week 2	3.9 score on a scale Standard Deviation 2.83
Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment Week 4	3.7 score on a scale Standard Deviation 2.49
Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment Week 6	3.5 score on a scale Standard Deviation 4.02
Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment Week 8	3.4 score on a scale Standard Deviation 3.92
Mean Caregiver Perception of Patient's Pain Score, as Measured by the Doloplus 2 Scale Behavioral Assessment Week 12	4.1 score on a scale Standard Deviation 4.08

Adverse Events

Intervention (I-HoME)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Veerawat Phongtankuel

Weill Cornell Medicine

Phone: 212-746-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place