HospiceNCT04243538

Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms in Home Hospice

A study testing I-HoME in people with Hospice, run by Weill Medical College of Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 110 yearsHealthy volunteers can take part
Conditions the study is for: Hospice
What is being tested?: I-HoME
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 14 Feb 2022to 10 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 110 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Home hospice caregivers must be:
English speaking
18 years of age or older
not blind
having a family member receiving home hospice care
Home hospice patients must be:

Show all 10Show fewer

English speaking
65 years of age or older
not blind
enrolled in home hospice care.

Who cannot join

Patients with a terminal diagnosis of dementia or patients who have cognitive impairment and unable to sign a written informed consent will be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Visiting Nurse Service of New York
New York, New York, 10017

Other trials in United States

About this study

Official title: Developing and Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms and Caregiver Burden in Home Hospice

With the growth of hospice, older adults have the opportunity to receive home-based care aimed at reducing suffering and focusing on quality of life at the end of life. While use of technology and educational videos has yet to be fully developed, structured, and evaluated in home hospice care, it has shown promise to improve care in other settings. Therefore, this study aims to develop and evaluate a multi-component technology-based care intervention, i.e., Improving Home hospice Management of End of life issues through technology (I-HoME).

Read the detailed description

The study intervention focuses on assessing and addressing patient symptoms in the home hospice setting through weekly telehealth visits (for up to 6 weeks) and educational videos that are geared for the patient's informal caregiver. The aim of this phase of the project is two fold. One is that the study team will conduct a single armed (N=6 dyads) pilot study with a focus on optimizing data collection protocols and the intervention. After this step, a randomized pilot study evaluating the feasibility and potential efficacy of I-HoME (N=50 dyads) compared to usual care (N=50 dyads) will be conducted.

Phase I of the study to assess feasibility of the intervention was registered on ClinicalTrials.gov as NCT04074304.

Conditions: Hospice
Being tested: I-HoME

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

I-HoMEBehavioural
I-HoME will consist of two components: (1) synchronous live video interactions between patients/CGs and a hospice nurse; and (2) educational videos.

Study groups in NCT04243538
Study group	Role	What they receive
Control arm	No intervention	Standard of care.
I-HoME intervention	Experimental	Weekly televisits with a nurse practitioner that will implement the I-HoME intervention. Receives: Behavioral: I-HoME

What is being measured

The primary outcome is the main question the study is designed to answer.

Participant Recruitment Rate
Recruitment rate was measured by the number of participants consented divided by the number of eligible participants.
Measured: During recruitment (22 months)
Participant Attrition From Enrollment to End of Study
This measure is the total number of participants who withdrew consent or were unreachable for study activities after consent.
Measured: At the end of the intervention or at 6 weeks, which ever is earlier.
Average Length of I-HoME Tele-visit
This measure was collected by calculating the average duration (in minutes) of each tele-visit between the participant in I-HoME intervention arm and the interventionalist.
Measured: At the end of the intervention or at 6 weeks, which ever is earlier.
Total Number of Educational Videos Watched by I-HoME Intervention Arm Participants
This measure is the total number of videos watched by the I-HoME intervention arm participants who received at least one tele-visit. Intervention arm participants self-reported whether they watched the educational videos recommended to them by the interventionist.
Measured: At the end of the intervention or at 6 weeks, which ever is earlier.
Number of I-HoME Intervention Caregivers Who Experienced Technical Issues During the Tele-visits.
The number of I-HoME intervention caregivers who reported at least one technical issues with the tele-visit. Participants in the intervention arm answered questions about whether they experienced technical issues.
Measured: At the end of the intervention or at 6 weeks, which ever is earlier.
Percentage of Tele-visits With Hardware Issues Out of the Total Number of Tele-visit Intervention Visits
After each intervention visit, participants answered questions about whether they experienced technical issues. This measure was calculated by dividing the number of I-HoME tele-visits during which the participant and/or the interventionist experienced hardware issues by the total number of I-HoME tele-visits administered during the entire study period.
Measured: At the end of the intervention or at 6 weeks, which ever is earlier.
Percentage of Tele-visits Conducted Out of the Total Possible Tele-visits.
This measure is calculated by dividing the tele-visits conducted out of the total possible tele-visits. This measure shows the adherence of the I-HoME intervention arm to the tele-visits.
Measured: At the end of the intervention or at 6 weeks, which ever is earlier.

Secondary outcomes (2)

Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks.
Symptom burden score as measured by the Edmonton Symptom Assessment Scale (ESAS). Scale is from a 0 to 90, with higher scores indicating higher symptom burden.
Measured: At baseline and weekly for 6 weeks.
Number of Patient Hospitalizations From Enrollment to End of Intervention
All hospitalizations of the caregivers' patient from enrollment to end of intervention
Measured: From enrollment to the end of the intervention or at 6 weeks, which ever is earlier.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 202210 Oct 2024

First posted28 Jan 2020
Study start14 Feb 2022
Primary completion10 Oct 2024
Study completion10 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HospiceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04243538
Sponsor's protocol ID: 20-11022933frmrly19-04020138-1
Other IDs: 1K76AG059997-01A1
Status last verified: Jul 2025
First submitted: 23 Jan 2020
Last updated: 7 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Prehospital Care of End-of-Life Patients by the Strasbourg Mobile Emergency and Resuscitation Service: A Qualitative Study of Healthcare Professionals' Experiences and Use of a Comfort Care Booklet
End-of-life Care, Palliative Care
Not yet recruiting
Inpatient Hospice Transitions Checklist
Dementia
Recruiting
CommunityRx-Dementia + Peer Navigation (CRxDpeer)
Alzheimer s Disease, Dementia
RecruitingObservational study
Life Sustaining Treatments in Critically Ill Children
Critical Illness, Ethics
Active, not recruiting
Implementing, Evaluating, and Scaling Up of the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) Program
Frail Elderly Syndrome

All Hospice trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Developing and Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms and Caregiver Burden in Home Hospice
ClinicalTrials.gov ID: NCT04243538
Acronym / sponsor ID: 20-11022933frmrly19-04020138-1
Conditions: Hospice
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Weill Medical College of Cornell UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA), Visiting Nurse Service of New York
Study start: 14 Feb 2022 (actual)
Primary completion: 10 Oct 2024 (actual)
Study completion: 10 Oct 2024 (actual)
First posted: 28 Jan 2020 (actual)
Results: Posted 7 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Phase I of the study to assess feasibility of the intervention was registered on ClinicalTrials.gov as NCT04074304.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control arm	No intervention	–Standard of care.
I-HoME intervention	Experimental	Behavioral: I-HoMEWeekly televisits with a nurse practitioner that will implement the I-HoME intervention.

Who may qualify

Ages: 18 to 110 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

English speaking
18 years of age or older
not blind
having a family member receiving home hospice care
English speaking

Key exclusion criteria (1 listed)

Patients with a terminal diagnosis of dementia or patients who have cognitive impairment and unable to sign a written informed consent will be excluded.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
I-HoMEI-HoME will consist of two components: (1) synchronous live video interactions between patients/CGs and a hospice nurse; and (2) educational videos.	Behavioural	I-HoME intervention

Primary outcome

Participant Recruitment Rate
Time frame: During recruitment (22 months)
Recruitment rate was measured by the number of participants consented divided by the number of eligible participants.
Participant Attrition From Enrollment to End of Study
Time frame: At the end of the intervention or at 6 weeks, which ever is earlier.
This measure is the total number of participants who withdrew consent or were unreachable for study activities after consent.
Average Length of I-HoME Tele-visit
Time frame: At the end of the intervention or at 6 weeks, which ever is earlier.
This measure was collected by calculating the average duration (in minutes) of each tele-visit between the participant in I-HoME intervention arm and the interventionalist.
Total Number of Educational Videos Watched by I-HoME Intervention Arm Participants
Time frame: At the end of the intervention or at 6 weeks, which ever is earlier.
This measure is the total number of videos watched by the I-HoME intervention arm participants who received at least one tele-visit. Intervention arm participants self-reported whether they watched the educational videos recommended to them by the interventionist.
Number of I-HoME Intervention Caregivers Who Experienced Technical Issues During the Tele-visits.
Time frame: At the end of the intervention or at 6 weeks, which ever is earlier.
The number of I-HoME intervention caregivers who reported at least one technical issues with the tele-visit. Participants in the intervention arm answered questions about whether they experienced technical issues.
Percentage of Tele-visits With Hardware Issues Out of the Total Number of Tele-visit Intervention Visits
Time frame: At the end of the intervention or at 6 weeks, which ever is earlier.
After each intervention visit, participants answered questions about whether they experienced technical issues. This measure was calculated by dividing the number of I-HoME tele-visits during which the participant and/or the interventionist experienced hardware issues by the total number of I-HoME tele-visits administered during the entire study period.
Percentage of Tele-visits Conducted Out of the Total Possible Tele-visits.
Time frame: At the end of the intervention or at 6 weeks, which ever is earlier.
This measure is calculated by dividing the tele-visits conducted out of the total possible tele-visits. This measure shows the adherence of the I-HoME intervention arm to the tele-visits.

2 secondary outcomes

Patients' Symptom Burden Score as Rated by the Caregiver, Measured at Baseline and Weekly for 6 Weeks.
Time frame: At baseline and weekly for 6 weeks.
Number of Patient Hospitalizations From Enrollment to End of Intervention
Time frame: From enrollment to the end of the intervention or at 6 weeks, which ever is earlier.

Results and safety

Results posted to the registry on 7 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Arm	40	40
I-HoME Intervention	40	35

Primary outcome: Participant Recruitment Rate

Time frame: During recruitment (22 months). Number. Unit: percentage of enrolled participants

Measure	All Participants n = 212
Value	37.7

Population analysed: All participants who we reached out to and were eligible for our study, including those who refused to participate, were unreachable over multiple attempts, and those who were initially interested in participating but not enrolled were included in the number of participants analyzed for this measure.

Primary outcome: Participant Attrition From Enrollment to End of Study

Time frame: At the end of the intervention or at 6 weeks, which ever is earlier.. Count of participants. Unit: Participants

Measure	Control Arm n = 40	I-HoME Intervention n = 40
Value	0	5

Population analysed: This measure includes all participants who were enrolled.

Primary outcome: Average Length of I-HoME Tele-visit

Time frame: At the end of the intervention or at 6 weeks, which ever is earlier.. Mean (Standard Deviation). Unit: minutes

Measure	Control Arm n = 0	I-HoME Intervention n = 35
Value	–	22.5 (11.32)

Population analysed: The measure was only assessed for the intervention arm. 5 subjects were excluded for this measure because 2 participants withdrew consent and 3 participants were lost to follow up, thus not receiving the intervention.

Primary outcome: Total Number of Educational Videos Watched by I-HoME Intervention Arm Participants

Time frame: At the end of the intervention or at 6 weeks, which ever is earlier.. Number. Unit: videos

Measure	Control Arm n = 0	I-HoME Intervention n = 35
Value	–	23

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Arm	0 of 40 (0%)	0 of 40 (0%)	0 of 40
I-HoME Intervention	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hospice

RecruitingObservational study
Prehospital Care of End-of-Life Patients by the Strasbourg Mobile Emergency and Resuscitation Service: A Qualitative Study of Healthcare Professionals' Experiences and Use of a Comfort Care Booklet
End-of-life Care, Palliative Care
Not yet recruiting
Inpatient Hospice Transitions Checklist
Dementia
Recruiting
CommunityRx-Dementia + Peer Navigation (CRxDpeer)
Alzheimer s Disease, Dementia
RecruitingObservational study
Life Sustaining Treatments in Critically Ill Children
Critical Illness, Ethics
Active, not recruiting
Implementing, Evaluating, and Scaling Up of the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) Program
Frail Elderly Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Veerawat Phongtankuel, MD, MS principal investigator

Weill Medical College of Cornell University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing I-HoME in people with Hospice, run by Weill Medical College of Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant Recruitment Rate (time frame: During recruitment (22 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04243538.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.