SupporTive Care At Home Research for Patients with Progressive Neurologic Disease Patients (STAHR-Neuro) (HOMECARE)

SupporTive Care At Home Research : Single-center, Single-arm, Investigator-initiated Exploratory Clinical Trial for Patients with Neurologic Disease Patients

To test the effects of home-based care on healthcare utilization within one Year (Hospitalization Status, Number of Hospitalizations, Unplanned Hospitalization Status, Number of Unplanned Hospitalizations, Length of Hospital Stay, Number of Emergency Room Visits, Number of Outpatient Visits) among progressive neurologic disease patients with decreased performance status. Home-based care includes education for patients and their family caregivers, home visits by specialized home-based medical staff, and regular status check-ups.

Study Overview

• Status: Recruiting
• Conditions: Supportive Care
• Intervention / Treatment: Other: SupporTive Care At Home

Detailed Description

This study is a Single-center, single-arm, investigator-initiated exploratory clinical trial to test the effects of home-based care on Healthcare Utilization within One Year (Hospitalization Status, Number of Hospitalizations, Unplanned Hospitalization Status, Number of Unplanned Hospitalizations, Length of Hospital Stay, Number of Emergency Room Visits, Number of Outpatient Visits)among neurologic disease Patients with decreased performance status. Home-based care includes education for patients and their family caregivers, home visits by specialized home-based medical staff, and regular status check-up. Study participants are recruiting from single institutions, aiming for 30 progressive neurologic disease patients.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahhyun Lee; Phone Number: 82-10-7280-8256; Email: leeahyun502@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Ah hyun Lee; Phone Number: 82-10-7280-8256; Email: leeahyun502@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Both the patient and their family caregiver must meet the criteria to be considered for this research.

Patient

Diagnosis of Progressive Neurological Disorders (Motor Neuron Disease, Parkinson's Disease) with ICD-10 codes (G12.2, G20, G11.9, G21, G22, G23, G30.8, G31.8, F02.3, etc.), additional diseases can be included depending on the patient's condition.

Individuals with a modified Rankin Score (mRS) of 3-5 A person who wishes to stay at home A person whose family caregiver resides at home A person who wishes to participate in the research Family Caregiver

A family* member of the patient

* Family: refers to the patient's spouse (including a common-law partner), descendants and their spouses up to the second degree, siblings and their spouses, and relatives and their spouses up to the eighth degree.

A person who meets one of the following conditions:

Lives with the patient (patient's household member) Does not live with the patient, but visits the patient's home more than three times a week A person who wants the patient to stay at home A person who can communicate easily with medical staff A person who wishes to participate in the research

Exclusion Criteria:

• If either the patient or the family caregiver meets any one of these criteria, they are excluded from the study.

Patient

A person who cannot speak, hear, or read Korean A person who is judged by a medical doctor to be unable to take part in this research due to extremely poor health A person residing outside the range that can be visited by the respective medical institution (the conditions for distance are to be specified by each medical institution)*

* This condition is not applicable for the control group.

A person who has used hospital- or home-type hospice and palliative care services A person who is under the age of 19 Family Caregiver

A person who cannot speak, hear, or read Korean A person who is judged by a medical doctor to be unable to take part in this research due to extremely poor health A person under the age of 19

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unplanned hospitalization	admission to the enrolled hospital to treat unexpected symptoms or medical conditions (not including planned admission for chemotherapy or admission for planned surgery or intervention) admission to a hospital other than the enrolled hospital admission to a nursing hospital for a duration of less than 4 weeks.	within One Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient end-of-life care: ICU admission	ICU admission one month before death	within 1 month before death
Patient end-of-life care: ventilator treatment	Mechanical ventilator apply one month before death	within 1 month before death
Patient end-of-life care: an advance directive	Completion of advance medical directives within 1 month before death	within 1 month before death
Patient medical utilization	The total number of hospital utilization, including hospitalization, emergency room visit, and clinic visits	within 12 months following enrollment
Hospitalization	the number of hospitalization	within 12 months following enrollment
ER visits	the number of emergency room visits	within 12 months following enrollment
Healthcare use	the number of healthcare use for severe diseases	within 12 months following enrollment
symptom management	IPOS-neuro S8 of patient	within 12 months following enrollment
Quality of life of patient - EQ-5D	Euro-Quality of Life-5 Dimension (EQ-5D) of patient	within 12 months following enrollment
Satisfaction with services (patient)	Satisfaction of the study participant (patient) with the service in this study, evaluated by questionnaire	within 12 months following enrollment
Quality of life of family caregiver	Euro-Quality of Life-5 Dimension (EQ-5D) of family caregiver	within 12 months following enrollment
Care burden of family caregiver	The Korean version of Caregiver Reaction Assessment (CRA-K) of family caregiver	within 12 months following enrollment
Depressive symptom of family caregiver	Patient Health Questionnaire-9 (PHQ-9) of family caregiver	within 12 months following enrollment
Caring competency of family caregiver	Caring competency of family caregiver, measured by questionnaire	within 12 months following enrollment
Satisfaction with services (family caregiver)	Satisfaction of the study participant (family caregiver) with the service in this study, evaluated by questionnaire	within 12 months following enrollment
Expenses	medical expenses, care expenses	within 12 months following enrollment

Collaborators and Investigators

• Sponsor: BeLong Cho

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: January 7, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: HC21C0115-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No