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Supportive CareNCT06663514

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

A study testing SupporTive Care At Home in people with Supportive Care, run by BeLong Cho at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Supportive Care
What is being tested?
SupporTive Care At Home
How many people
30 participants
Where
1 siteSouth Korea
Study dates
23 Aug 2022to 31 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ahhyun Lee contact

82-10-7280-8256

leeahyun502@snu.ac.kr

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Ah hyun Lee, 82-10-7280-8256, leeahyun502@snu.ac.kr

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Conditions
Supportive Care
Being tested
SupporTive Care At Home

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SupporTive Care At HomeOther

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: within One Year

Secondary outcomes (16)

  1. Patient medical utilization

    The total number of hospital utilization, including hospitalization, emergency room visit, and clinic visits

    Measured: within 12 months following enrollment

  2. Hospitalization

    the number of hospitalization

    Measured: within 12 months following enrollment

  3. ER visits

    the number of emergency room visits

    Measured: within 12 months following enrollment

  4. Healthcare use

    the number of healthcare use for severe diseases

    Measured: within 12 months following enrollment

  5. Patient end-of-life care: ICU admission

    ICU admission one month before death

    Measured: within 1 month before death

  6. Patient end-of-life care: ventilator treatment

    Mechanical ventilator apply one month before death

    Measured: within 1 month before death

  7. Patient end-of-life care: an advance directive

    Completion of advance medical directives within 1 month before death

    Measured: within 1 month before death

  8. symptom management

    IPOS-neuro S8 of patient

    Measured: within 12 months following enrollment

  9. Quality of life of patient - EQ-5D

    Euro-Quality of Life-5 Dimension (EQ-5D) of patient

    Measured: within 12 months following enrollment

  10. Satisfaction with services (patient)

    Satisfaction of the study participant (patient) with the service in this study, evaluated by questionnaire

    Measured: within 12 months following enrollment

  11. Quality of life of family caregiver

    Euro-Quality of Life-5 Dimension (EQ-5D) of family caregiver

    Measured: within 12 months following enrollment

  12. Care burden of family caregiver

    The Korean version of Caregiver Reaction Assessment (CRA-K) of family caregiver

    Measured: within 12 months following enrollment

  13. Depressive symptom of family caregiver

    Patient Health Questionnaire-9 (PHQ-9) of family caregiver

    Measured: within 12 months following enrollment

  14. Caring competency of family caregiver

    Caring competency of family caregiver, measured by questionnaire

    Measured: within 12 months following enrollment

  15. Satisfaction with services (family caregiver)

    Satisfaction of the study participant (family caregiver) with the service in this study, evaluated by questionnaire

    Measured: within 12 months following enrollment

  16. Expenses

    medical expenses, care expenses

    Measured: within 12 months following enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2024
  2. Study start23 Aug 2022
  3. Primary completion31 May 2026 (estimated)
  4. Study completion31 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06663514
Sponsor's protocol ID
HC21C0115-2
Status last verified
Jan 2024
First submitted
7 Jan 2024
Last updated
29 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SupporTive Care At Home in people with Supportive Care, run by BeLong Cho at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ahhyun Lee (82-10-7280-8256, leeahyun502@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unplanned hospitalization (time frame: within One Year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06663514.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.

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