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
Sponsored by
About this trial
This is an interventional supportive care trial for Home Hospice
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.
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
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.
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
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
No
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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