NCT06663514

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Aug 2022May 2026

Study Start

First participant enrolled

August 23, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2024

Completed
10 months until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Last Updated

October 29, 2024

Status Verified

January 1, 2024

Enrollment Period

3.8 years

First QC Date

January 7, 2024

Last Update Submit

October 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Patient medical utilization

    within 12 months following enrollment

  • Hospitalization

    within 12 months following enrollment

  • ER visits

    within 12 months following enrollment

  • Healthcare use

    within 12 months following enrollment

  • Patient end-of-life care: ICU admission

    within 1 month before death

  • +11 more secondary outcomes

Interventions

Home-based medical care is based on a specialized home-based medical team approach, including following: Specialized Home-Based Medical Team Approach Initial Assessment and Education Initial Home Visits and Education Multidisciplinary Team Meeting Regular Assessment After the Initial Visit

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 7, 2024

First Posted

October 29, 2024

Study Start

August 23, 2022

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

October 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations