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Developing and Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms and Caregiver Burden in Home Hospice. Phase 1.

Primary Purpose

Home Hospice

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

I-HoME

About this trial

This is an interventional supportive care trial for Home Hospice

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Home hospice providers (N=10) and family caregivers (N=10) must be English speaking, 18 years of age or older, not blind, and either providing or receiving home hospice care. Home hospice patients (N=10) must be English speaking, 65 years of age or older, not blind, and 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.

Sites / Locations

The Visiting Nurse Service of New York

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

I-HoME prototype

Arm Description

Participants will be shown prototype of I-HoME and provide feedback as part of the user-center design process.

Outcomes

Primary Outcome Measures

Participants' experience using the intervention as measured by the I-HoME User-centered design questionnaire

A questionnaire consisting of open ended questions asking participants to provide feedback and their thoughts about the I-HoME intervention. The responses gathered are not scored, but qualitative analysis will be performed to identify issues that will be used to make revisions to the I-HoME intervention before starting phase 2 of the project.

Secondary Outcome Measures

Full Information

NCT ID

NCT04074304

First Posted

August 28, 2019

Last Updated

March 22, 2023

Sponsor

Weill Medical College of Cornell University

Collaborators

Visiting Nurse Service of New York, National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT04074304

Brief Title

Developing and Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms and Caregiver Burden in Home Hospice. Phase 1.

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

May 18, 2021 (Actual)

Primary Completion Date

November 3, 2021 (Actual)

Study Completion Date

November 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

Visiting Nurse Service of New York, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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), that focuses on assessing and addressing patient symptoms and caregiver burden in the home hospice setting through synchronous live video visits and educational videos. The aim of the first phase of the project is to employ an iterative user-centered design process to develop I-HoME for home hospice patients and their caregivers prior to implementation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Home Hospice

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

I-HoME prototype

Arm Type

Other

Arm Description

Participants will be shown prototype of I-HoME and provide feedback as part of the user-center design process.

Intervention Type

Other

Intervention Name(s)

I-HoME

Intervention Description

A multi-component technology-based care intervention.

Primary Outcome Measure Information:

Title

Participants' experience using the intervention as measured by the I-HoME User-centered design questionnaire

Description

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

110 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Home hospice providers (N=10) and family caregivers (N=10) must be English speaking, 18 years of age or older, not blind, and either providing or receiving home hospice care. Home hospice patients (N=10) must be English speaking, 65 years of age or older, not blind, and 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Veerawat Phongtankuel, MD, MS

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Visiting Nurse Service of New York

City

New York

State/Province

New York

ZIP/Postal Code

10017

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Developing and Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms and Caregiver Burden in Home Hospice. Phase 1.

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