Clinical trial NCT04243538: Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms in Home Hospice
Official title: Developing and Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms and Caregiver Burden in Home Hospice
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hospice
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Visiting Nurse Service of New York
First posted: 2020-01-28
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility measurements 1
timeFrame: At the end of the intervention or at 6 weeks, which ever is earlier.
measure: Feasibility measurement 2
timeFrame: At the end of the intervention or at 6 weeks, which ever is earlier.
measure: Feasibility measurement 3
timeFrame: At the end of the intervention or at 6 weeks, which ever is earlier.
measure: Feasibility measurement 4
timeFrame: At the end of the intervention or at 6 weeks, which ever is earlier.
measure: Feasibility measurement 5
timeFrame: At the end of the intervention or at 6 weeks, which ever is earlier.
measure: Feasibility measurement 6
timeFrame: At the end of the intervention or at 6 weeks, which ever is earlier.
measure: Feasibility measurement 7
timeFrame: At the end of the intervention or at 6 weeks, which ever is earlier.
measure: Feasibility measurement 8
timeFrame: At the end of the intervention or at 6 weeks, which ever is earlier.
Secondary outcomes:
measure: Change in symptom burden as measured by the Edmonton Symptom Assessment Scale
timeFrame: 1, 2, 3, 4, 5, 6 weeks
measure: Change in caregiver burden as measured by the Zarit Burden Interview - short form
timeFrame: 1, 2, 3, 4, 5, 6 weeks
measure: Number of patient hospitalizations
timeFrame: At the end of the intervention or at 6 weeks, which ever is earlier.
Other outcomes:
Locations:
city: New York
country: United States
facility: The Visiting Nurse Service of New York
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Veerawat Phongtankuel, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: