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

Hospice Clinical Trial

Official title:

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Hospice

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.