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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074304
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and will resume based on guidance of public health authorities. This is not a suspension of IRB approval)
First Posted : August 30, 2019
Last Update Posted : May 28, 2020
Sponsor:
Collaborators:
The Visiting Nurse Service of New York
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Home Hospice Other: I-HoME Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Developing and Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms and Caregiver Burden in Home Hospice
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
I-HoME prototype
Participants will be shown prototype of I-HoME and provide feedback as part of the user-center design process.
Other: I-HoME
A multi-component technology-based care intervention.




Primary Outcome Measures :
  1. Participants' experience using the intervention as measured by the I-HoME User-centered design questionnaire [ Time Frame: 1 day ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074304


Locations
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United States, New York
The Visiting Nurse Service of New York
New York, New York, United States, 10017
Sponsors and Collaborators
Weill Medical College of Cornell University
The Visiting Nurse Service of New York
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Veerawat Phongtankuel, MD, MS Weill Cornell Medicine
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04074304    
Other Study ID Numbers: 19-04020138
1K76AG059997-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No