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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hospice

Intervention / Treatment
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* Behavioral: I-HoME


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm<br>Standard of care. | |
| Experimental: I-HoME intervention<br>Weekly televisits with a nurse practitioner that will implement the I-HoME intervention. | Behavioral: I-HoME<br>* I-HoME will consist of two components: (1) synchronous live video interactions between patients/CGs and a hospice nurse; and (2) educational videos.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Feasibility measurement 2 | Feasibility as measured by accrual rates | At the end of the intervention or at 6 weeks, which ever is earlier. | 
| 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. | 
| Feasibility measurement 4 | Feasibility as measured by attrition rates | At the end of the intervention or at 6 weeks, which ever is earlier. | 
| 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. | 
| 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. | 
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Number of patient hospitalizations | All hospitalizations will be included | At the end of the intervention or at 6 weeks, which ever is earlier. |