Clinical trial NCT06663514: SupporTive Care At Home Research for Patients with Progressive Neurologic Disease Patients (STAHR-Neuro) (HOMECARE)
Official title: SupporTive Care At Home Research : Single-center, Single-arm, Investigator-initiated Exploratory Clinical Trial for Patients with Neurologic Disease Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Supportive Care
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Unplanned hospitalization
timeFrame: within One Year
Secondary outcomes:
measure: Patient medical utilization
timeFrame: within 12 months following enrollment
measure: Hospitalization
timeFrame: within 12 months following enrollment
measure: ER visits
timeFrame: within 12 months following enrollment
measure: Healthcare use
timeFrame: within 12 months following enrollment
measure: Patient end-of-life care: ICU admission
timeFrame: within 1 month before death
measure: Patient end-of-life care: ventilator treatment
timeFrame: within 1 month before death
measure: Patient end-of-life care: an advance directive
timeFrame: within 1 month before death
measure: symptom management
timeFrame: within 12 months following enrollment
measure: Quality of life of patient - EQ-5D
timeFrame: within 12 months following enrollment
measure: Satisfaction with services (patient)
timeFrame: within 12 months following enrollment
measure: Quality of life of family caregiver
timeFrame: within 12 months following enrollment
measure: Care burden of family caregiver
timeFrame: within 12 months following enrollment
measure: Depressive symptom of family caregiver
timeFrame: within 12 months following enrollment
measure: Caring competency of family caregiver
timeFrame: within 12 months following enrollment
measure: Satisfaction with services (family caregiver)
timeFrame: within 12 months following enrollment
measure: Expenses
timeFrame: within 12 months following enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: