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

Overview

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).

Full Title of Study: “Developing and Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms and Caregiver Burden in Home Hospice”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2024

Detailed 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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • No Intervention: Control arm
    • Standard of care.
  • Experimental: I-HoME intervention
    • Weekly televisits with a nurse practitioner that will implement the I-HoME intervention.

Clinical Trial Outcome Measures

Primary Measures

  • Feasibility measurements 1
    • Time Frame: At the end of the intervention or at 6 weeks, which ever is earlier.
    • Feasibility as measured by I-HoME feasibility questionnaire
  • Feasibility measurement 2
    • Time Frame: At the end of the intervention or at 6 weeks, which ever is earlier.
    • Feasibility as measured by accrual rates
  • Feasibility measurement 3
    • Time Frame: At the end of the intervention or at 6 weeks, which ever is earlier.
    • Feasibility as measured by number of hardware issues
  • Feasibility measurement 4
    • Time Frame: At the end of the intervention or at 6 weeks, which ever is earlier.
    • Feasibility as measured by attrition rates
  • Feasibility measurement 5
    • Time Frame: At the end of the intervention or at 6 weeks, which ever is earlier.
    • Feasibility as measured by number of synchronous video visits during the course of the intervention with patient and/or caregiver
  • Feasibility measurement 6
    • Time Frame: At the end of the intervention or at 6 weeks, which ever is earlier.
    • Feasibility as measured by duration of synchronous video visits with the patient and or caregiver
  • Feasibility measurement 7
    • Time Frame: At the end of the intervention or at 6 weeks, which ever is earlier.
    • Feasibility as measured by number of video views
  • Feasibility measurement 8
    • Time Frame: At the end of the intervention or at 6 weeks, which ever is earlier.
    • Feasibility as measured by number of software issues

Secondary Measures

  • Change in symptom burden as measured by the Edmonton Symptom Assessment Scale
    • Time Frame: 1, 2, 3, 4, 5, 6 weeks
    • Symptom burden, as measured by the Edmonton Symptom Assessment Scale. Scale is from a 0 to 90, with higher scores indicating higher symptom burden.
  • Change in caregiver burden as measured by the Zarit Burden Interview – short form
    • Time Frame: 1, 2, 3, 4, 5, 6 weeks
    • Caregiver burden, as measured by the Zarit Burden Interview – short form. Scale is from 0 to 48, with higher scores indicating higher caregiver burden.
  • Number of patient hospitalizations
    • Time Frame: At the end of the intervention or at 6 weeks, which ever is earlier.
    • All hospitalizations will be included

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 110 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Weill Medical College of Cornell University
  • Collaborator
    • National Institute on Aging (NIA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Veerawat Phongtankuel, MD, MS, Principal Investigator, Weill Medical College of Cornell University
  • Overall Contact(s)
    • Veerawat Phongtankuel, MD, MS, 212-746-7000, vep9012@med.cornell.edu

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