Hospitalization RateNCT04638179
Efficacy of Multi-disciplinary Integrated Post-acute Care in Patients Admission for Heart Failure
An observational study of Hospitalization Rate and Mortality Rate, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background: Clinical heart failure patients always suffering from (1) worsen symptoms such as decreased activity tolerance, end-to-end breathing and excessive body fluid volume; (2) high medical expenses results from hospitalization; (3) reduced quality of life . Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hospitalization Rate, Mortality Rate, Functional Recovery
- What is being tested?
- Not intervention.Use retrospective case contrl study.
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2018to 16 Nov 2020
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Exclusion Criteria: * (1) Age over20 years, (2) long-term dialysis, (3) unconsciousness, (4) complete bed rest without self-care ability, (5) those with ventilator dependence, (6) ventricular assist device (VAD) has been implanted, (7) heart transplants , (8) refused to join the research.
Who may be able to join
- Clinical diagnosis of Heart Failure
- The experimental group is a patient who was managed by the NHIA 's acute post-care plan. Provide interdisciplinary comprehensive care in accordance with the norms and conduct health education during hospitalization. Hospitalized Chinese pharmacists, dietitians, physiotherapists and case managers participate in health education and will continue to be interviewed and have heart consultations within six months of discharge.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
NTUH
Taipei, No. 7, Zhongshan S. Rd., Zhongzheng Dist., Tai, 100225
About this study
Background: Clinical heart failure patients always suffering from (1) worsen symptoms such as decreased activity tolerance, end-to-end breathing and excessive body fluid volume; (2) high medical expenses results from hospitalization; (3) reduced quality of life . In 2018, following instruction from National Health Insurance Administration (NHIA), the National Taiwan University Hospital (NTUH) undertook National Health Insurance post-acute care program, PAC in charge of heart failure patients by multi-disciplinary integrated to reduce acute exacerbations(AE), control symptoms, improve quality of life and increase survival rate.
Read the detailed description
Objective: To evaluate the outcome of patients with heart failure who been taken are of multi-disciplinary integrated instructed by National Health Insurance Administration (NHIA)
Methods: Use retrospective case contrl study. Adopted the hospitalized patients diagnosed with heart failure in the NTUH as the research sample, and collected the retrospective data for analysis in a two-group study design. (1) The experimental group is a patient who was managed by the NHIA 's acute post-care plan. Provide interdisciplinary comprehensive care in accordance with the norms and conduct health education during hospitalization. Hospitalized Chinese pharmacists, dietitians, physiotherapists and case managers participate in health education and will continue to be interviewed and have heart consultations within six months of discharge. (2)The control group received traditional health education in general care and routine health care.
Time of review: From February 2, 2018, the implementation of the National Health Insurance Agency's acute post-care plan day to December 31, 2019, and continuous tracking of effectiveness for one year.
Exclusion conditions: (1) Age over20 years, (2) long-term dialysis, (3) unconsciousness, (4) complete bed rest without self-care ability, (5) those with ventilator dependence, (6) ventricular assist device (VAD) has been implanted, (7) heart transplants , (8) refused to join the research.
The monitoring indicators: Hospitalization rate within 180 days, mortality rate within one year , functional recovery, left ventricle ejection fraction (LVEF), NT-pro BNP, etc.
- Conditions
- Hospitalization Rate, Mortality Rate, Functional Recovery, Left Ventricle Ejection Fraction, NT-pro BNP
- Being tested
- Not intervention.Use retrospective case contrl study.
- Keywords
- National Health Insurance Administration post-acute care program, Heart Failure, multi-disciplinary integrated
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not intervention.Use retrospective case contrl study.Other
Also called Use retrospective case contrl study.
Use retrospective case contrl study.
| Study group | Role | What they receive |
|---|---|---|
| HF-PAC | (1) The experimental group is a patient who was managed by the NHIA 's acute post-care plan. Provide interdisciplinary comprehensive care in accordance with the norms and conduct health education during hospitalization. Hospitalized Chinese pharmacists, dietitians, physiotherapists and case managers participate in health education and will continue to be interviewed and have heart consultations within six months of discharge. Receives: Other: Not intervention.Use retrospective case contrl study. | |
| HF-non PAC | (2)The control group received traditional health education in general care and routine health care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization rate within 180 days
Hospitalization rate
Measured: within 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start1 Feb 2018
- Primary completion31 Dec 2019
- Study completion16 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalization RateStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638179
- Sponsor's protocol ID
- 202006182RIND
- Status last verified
- Feb 2018
- First submitted
- 30 Oct 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Multi-disciplinary Integrated Post-acute Care in Patients Admission for Heart Failure
- ClinicalTrials.gov ID
- NCT04638179
- Acronym / sponsor ID
- 202006182RIND
- Conditions
- Hospitalization Rate, Mortality Rate, Functional Recovery, Left Ventricle Ejection Fraction, NT-pro BNP
- Keywords
- National Health Insurance Administration post-acute care program, Heart Failure, multi-disciplinary integrated
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Clinical heart failure patients always suffering from (1) worsen symptoms such as decreased activity tolerance, end-to-end breathing and excessive body fluid volume; (2) high medical expenses results from hospitalization; (3) reduced quality of life . In 2018, following instruction from National Health Insurance Administration (NHIA), the National Taiwan University Hospital (NTUH) undertook National Health Insurance post-acute care program, PAC in charge of heart failure patients by multi-disciplinary integrated to reduce acute exacerbations(AE), control symptoms, improve quality of life and increase survival rate.
Detailed description
Objective: To evaluate the outcome of patients with heart failure who been taken are of multi-disciplinary integrated instructed by National Health Insurance Administration (NHIA)
Methods: Use retrospective case contrl study. Adopted the hospitalized patients diagnosed with heart failure in the NTUH as the research sample, and collected the retrospective data for analysis in a two-group study design. (1) The experimental group is a patient who was managed by the NHIA 's acute post-care plan. Provide interdisciplinary comprehensive care in accordance with the norms and conduct health education during hospitalization. Hospitalized Chinese pharmacists, dietitians, physiotherapists and case managers participate in health education and will continue to be interviewed and have heart consultations within six months of discharge. (2)The control group received traditional health education in general care and routine health care.
Time of review: From February 2, 2018, the implementation of the National Health Insurance Agency's acute post-care plan day to December 31, 2019, and continuous tracking of effectiveness for one year.
Exclusion conditions: (1) Age over20 years, (2) long-term dialysis, (3) unconsciousness, (4) complete bed rest without self-care ability, (5) those with ventilator dependence, (6) ventricular assist device (VAD) has been implanted, (7) heart transplants , (8) refused to join the research.
The monitoring indicators: Hospitalization rate within 180 days, mortality rate within one year , functional recovery, left ventricle ejection fraction (LVEF), NT-pro BNP, etc.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HF-PAC | – | Other: Not intervention.Use retrospective case contrl study.(1) The experimental group is a patient who was managed by the NHIA 's acute post-care plan. Provide interdisciplinary comprehensive care in accordance with the norms and conduct health education during hospitalization. Hospitalized Chinese pharmacists, dietitians, physiotherapists and case managers participate in health education and will continue to be interviewed and have heart consultations within six months of discharge. |
| HF-non PAC | – | –(2)The control group received traditional health education in general care and routine health care. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Exclusion Criteria: * (1) Age over20 years, (2) long-term dialysis, (3) unconsciousness, (4) complete bed rest without self-care ability, (5) those with ventilator dependence, (6) ventricular assist device (VAD) has been implanted, (7) heart transplants , (8) refused to join the research.
Key inclusion criteria (2 listed)
- Clinical diagnosis of Heart Failure
- The experimental group is a patient who was managed by the NHIA 's acute post-care plan. Provide interdisciplinary comprehensive care in accordance with the norms and conduct health education during hospitalization. Hospitalized Chinese pharmacists, dietitians, physiotherapists and case managers participate in health education and will continue to be interviewed and have heart consultations within six months of discharge.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not intervention.Use retrospective case contrl study.Also: Use retrospective case contrl study.Use retrospective case contrl study. | Other | HF-PAC |
Primary outcome
Hospitalization rate within 180 days
Time frame: within 180 days
Hospitalization rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalization Rate and Mortality Rate, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 0 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: finished, as of the sponsor's last update on 20 Nov 2020. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization rate within 180 days (time frame: within 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2020.