Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms in Home Hospice
- Conditions
- Hospice
- Interventions
- Behavioral: I-HoME
- Registration Number
- NCT04243538
- Lead Sponsor
- Weill Medical College of Cornell University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 220
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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description I-HoME intervention I-HoME Weekly televisits with a nurse practitioner that will implement the I-HoME intervention.
- Primary Outcome Measures
Name Time Method Feasibility measurement 3 At the end of the intervention or at 6 weeks, which ever is earlier. Feasibility as measured by number of hardware issues
Feasibility measurement 5 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 4 At the end of the intervention or at 6 weeks, which ever is earlier. Feasibility as measured by attrition rates
Feasibility measurements 1 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 At the end of the intervention or at 6 weeks, which ever is earlier. Feasibility as measured by accrual rates
Feasibility measurement 6 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 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 At the end of the intervention or at 6 weeks, which ever is earlier. Feasibility as measured by number of software issues
- Secondary Outcome Measures
Name Time Method Change in caregiver burden as measured by the Zarit Burden Interview - short form 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.
Change in symptom burden as measured by the Edmonton Symptom Assessment Scale 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.
Number of patient hospitalizations At the end of the intervention or at 6 weeks, which ever is earlier. All hospitalizations will be included
Trial Locations
- Locations (1)
The Visiting Nurse Service of New York
🇺🇸New York, New York, United States