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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04243538
Other study ID # 20-11022933frmrly19-04020138-1
Secondary ID 1K76AG059997-01A
Status Recruiting
Phase N/A
First received
Last updated
Start date February 14, 2022
Est. completion date June 30, 2024

Study information

Verified date February 2024
Source Weill Medical College of Cornell University
Contact Veerawat Phongtankuel, MD, MS
Phone 212-746-7000
Email vep9012@med.cornell.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 110 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
United States The Visiting Nurse Service of New York New York New York

Sponsors (3)

Lead Sponsor Collaborator
Weill Medical College of Cornell University National Institute on Aging (NIA), Visiting Nurse Service of New York

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility measurements 1 Feasibility as measured by I-HoME feasibility questionnaire At the end of the intervention or at 6 weeks, which ever is earlier.
Primary Feasibility measurement 2 Feasibility as measured by accrual rates At the end of the intervention or at 6 weeks, which ever is earlier.
Primary Feasibility measurement 3 Feasibility as measured by number of hardware issues At the end of the intervention or at 6 weeks, which ever is earlier.
Primary Feasibility measurement 4 Feasibility as measured by attrition rates At the end of the intervention or at 6 weeks, which ever is earlier.
Primary Feasibility measurement 5 Feasibility as measured by number of synchronous video visits during the course of the intervention with patient and/or caregiver At the end of the intervention or at 6 weeks, which ever is earlier.
Primary Feasibility measurement 6 Feasibility as measured by duration of synchronous video visits with the patient and or caregiver At the end of the intervention or at 6 weeks, which ever is earlier.
Primary Feasibility measurement 7 Feasibility as measured by number of video views At the end of the intervention or at 6 weeks, which ever is earlier.
Primary Feasibility measurement 8 Feasibility as measured by number of software issues At the end of the intervention or at 6 weeks, which ever is earlier.
Secondary Change in symptom burden as measured by the Edmonton Symptom Assessment Scale Symptom burden, as measured by the Edmonton Symptom Assessment Scale. Scale is from a 0 to 90, with higher scores indicating higher symptom burden. 1, 2, 3, 4, 5, 6 weeks
Secondary Change in caregiver burden as measured by the Zarit Burden Interview - short form Caregiver burden, as measured by the Zarit Burden Interview - short form. Scale is from 0 to 48, with higher scores indicating higher caregiver burden. 1, 2, 3, 4, 5, 6 weeks
Secondary Number of patient hospitalizations All hospitalizations will be included At the end of the intervention or at 6 weeks, which ever is earlier.
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