- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04074304
Developing and Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms and Caregiver Burden in Home Hospice. Phase 1.
March 22, 2023 updated by: Weill Medical College of Cornell University
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), 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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10017
- The Visiting Nurse Service of New York
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 110 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: I-HoME prototype
Participants will be shown prototype of I-HoME and provide feedback as part of the user-center design process.
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A multi-component technology-based care intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants' experience using the intervention as measured by the I-HoME User-centered design questionnaire
Time Frame: 1 day
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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.
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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Veerawat Phongtankuel, MD, MS, Weill Medical College of Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 18, 2021
Primary Completion (Actual)
November 3, 2021
Study Completion (Actual)
November 3, 2021
Study Registration Dates
First Submitted
August 28, 2019
First Submitted That Met QC Criteria
August 28, 2019
First Posted (Actual)
August 30, 2019
Study Record Updates
Last Update Posted (Actual)
March 24, 2023
Last Update Submitted That Met QC Criteria
March 22, 2023
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-11022933 frmrly 19-04020138
- 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Home Hospice
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VA Office of Research and DevelopmentCompletedCaregiver | Disabled Veterans | Referred to Long-term Care | Residing at Home | Hospice IneligibleUnited States
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University of WashingtonNational Institute of Nursing Research (NINR)Completed
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University of Colorado, DenverNational Institute on Aging (NIA)Completed
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University of Colorado, DenverNational Institute on Aging (NIA)CompletedHospice | Hospice Decision Making | End-of-life Decision MakingUnited States
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Mayo ClinicCompletedPalliative Care | Intensive Care Unit | HospiceUnited States
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Changhua Christian HospitalCompletedSurvival | Hospice | Alternative Medicine | Skin Electric ConductanceTaiwan
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Silesian University of MedicineCompletedHospice Care | Complementary Alternative Medicine | Complementary Alternative TherapyPoland
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National Taiwan University HospitalNot yet recruitingPalliative Medicine | Hospice | Terminal Cancer
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Weill Medical College of Cornell UniversityNational Institute on Aging (NIA); VNS HealthEnrolling by invitationCaregivers of Patients on Hospice CareUnited States, Puerto Rico
Clinical Trials on I-HoME
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Weill Medical College of Cornell UniversityNational Institute on Aging (NIA); Visiting Nurse Service of New YorkRecruiting
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University of Alabama at BirminghamRecruitingWomen's Health | Low-Income PopulationUnited States
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Queen's University, BelfastBelfast Health and Social Care TrustCompleted
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VA Office of Research and DevelopmentUniversity of Colorado, DenverCompletedPhysical DeconditioningUnited States
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Daiichi SankyoMerck Sharp & Dohme LLCNot yet recruitingSmall Cell Lung CancerUnited States, Spain, Germany, Hungary, China, Italy, Korea, Republic of, United Kingdom, France, Belgium, Japan, Taiwan, Netherlands, Australia, Portugal, Poland, Turkey, Switzerland, Brazil, Canada, Romania
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London School of Hygiene and Tropical MedicineUniversity College, London; World Health Organization; UNITAID; Liverpool School... and other collaboratorsCompleted
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National University Health System, SingaporeNational University of SingaporeCompleted
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Silesian Centre for Heart DiseasesNational Center for Research and Development, PolandCompleted
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Massachusetts General HospitalPatient-Centered Outcomes Research Institute; Children's Hospital of Philadelphia and other collaboratorsNot yet recruitingTracheostomy | Caregiver BurdenUnited States
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JHSPH Center for Clinical TrialsNational Heart, Lung, and Blood Institute (NHLBI)Not yet recruitingCardiovascular HealthUnited States