NCT04243538

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

February 14, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
10 months until next milestone

Results Posted

Study results publicly available

August 7, 2025

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

2.7 years

First QC Date

January 23, 2020

Results QC Date

June 20, 2025

Last Update Submit

July 18, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • Participant Recruitment Rate

    Recruitment rate was measured by the number of participants consented divided by the number of eligible participants.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    At baseline and weekly for 6 weeks.

  • Number of Patient Hospitalizations From Enrollment to End of Intervention

    From enrollment to the end of the intervention or at 6 weeks, which ever is earlier.

Study Arms (2)

Control arm

NO INTERVENTION

Standard of care.

I-HoME intervention

EXPERIMENTAL

Weekly televisits with a nurse practitioner that will implement the I-HoME intervention.

Behavioral: I-HoME

Interventions

I-HoMEBEHAVIORAL

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

I-HoME intervention

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Visiting Nurse Service of New York

New York, New York, 10017, United States

Location

Results Point of Contact

Title
Dr. Veerawat Phongtankuel
Organization
Weill Cornell Medicine

Study Officials

  • Veerawat Phongtankuel, MD, MS

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 28, 2020

Study Start

February 14, 2022

Primary Completion

October 10, 2024

Study Completion

October 10, 2024

Last Updated

August 7, 2025

Results First Posted

August 7, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations