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

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).

Study Overview

• Status: Completed
• Conditions: Hospice
• Intervention / Treatment: Behavioral: I-HoME

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • The Visiting Nurse Service of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; Standard of care.
Experimental: I-HoME intervention; Weekly televisits with a nurse practitioner that will implement the I-HoME intervention.	Behavioral: I-HoME; I-HoME will consist of two components: (1) synchronous live video interactions between patients/CGs and a hospice nurse; and (2) educational videos.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	From enrollment to the end of the intervention or at 6 weeks, which ever is earlier.

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute on Aging (NIA); Visiting Nurse Service of New York
• Investigators: Principal Investigator: Veerawat Phongtankuel, MD, MS, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): October 10, 2024
• Study Completion (Actual): October 10, 2024

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: 20-11022933frmrly19-04020138-1; 1K76AG059997-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No