Nurse's RoleNCT05987267
Nurse-led Multidisciplinary Precision Care for Patients With Chronic Heart Failure
A study testing multidisciplinary precision care in people with Nurse's Role and Multidisciplinary Communication, run by Zhongshan People's Hospital, Guangdong, China at 1 site in China.
Trial summary
This study aimed to evaluate the feasibility and effectiveness of a nurse-led multidisciplinary precision care in early cardiac rehabilitation of patients with chronic heart failure, and further to promote the application of nurse-led multidisciplinary precision care. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nurse's Role, Multidisciplinary Communication, Chronic Heart Failure
- What is being tested?
- multidisciplinary precision care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2021to 31 Dec 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 to 80 years;
- Conscious, with normal cognitive function and being communicable;
- NYHA heart function class II-IV;
- Patients met the diagnostic criteria of the clinical guidelines for the diagnosis and treatment of heart failure and were diagnosed with chronic heart failure;
- Informed consent was obtained.
Who cannot join
- Patients with congenital heart disease, cardiac shock, or persistent hypotension;
- Patients with severe liver and kidney dysfunction, moderate to severe anemia or coagulation disorders, and other serious systemic complications;
- Patients with a history of mental illness, a state of severe anxiety or depression, cognitive or communication impairments, and inability to communicate and respond to investigations;
- Patients have been involved in other research that would interfere with this study;
- Patients who declined cardiac rehabilitation and signed informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate the feasibility and effectiveness of a nurse-led multidisciplinary precision care in early cardiac rehabilitation of patients with chronic heart failure, and further to promote the application of nurse-led multidisciplinary precision care.
Read the detailed description
Enrolled patients were randomly divided as 1:1 ratio to experimental group and control group, while experimental group received nurse-led multidisciplinary precision care and the control group received standard care according to guidelines. The primary and secondary outcomes were evaluated and analyzed.
- Being tested
- multidisciplinary precision care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidisciplinary precision careOther
The experimental group received precision nursing based on a multidisciplinary collaborative team in addition to standard treatment and care
| Study group | Role | What they receive |
|---|---|---|
| multidisciplinary precision care group | Experimental | Give the intervention of nurse-led multidisciplinary precision care Receives: Other: multidisciplinary precision care |
| control group | No intervention | standard care according to guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular ejection fraction
Measured: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
6-minute walking distance
Measured: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Secondary outcomes (4)
the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life (QoL) questionnaires (QLQ) QLQ-C30 (version 3.0) score Quality of Life
Measured: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Symptom Check List-90
Measured: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Performance Status Score
Measured: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Numbers of patients with cardiovascular complications
Measured: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start24 Nov 2021
- Primary completion10 Apr 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuxian Zhu, Zhongshan People's Hospital, Guangdong, China
- Investigators
- Xiuxian Zhu, Study chair, Zhongshan People's Hospital, Guangdong, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987267
- Sponsor's protocol ID
- K2019-017
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-led Multidisciplinary Precision Care for Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT05987267
- Acronym / sponsor ID
- K2019-017
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, ChinaUniversity, hospital or other
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Aug 2023 (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.
This study aimed to evaluate the feasibility and effectiveness of a nurse-led multidisciplinary precision care in early cardiac rehabilitation of patients with chronic heart failure, and further to promote the application of nurse-led multidisciplinary precision care.
Detailed description
Enrolled patients were randomly divided as 1:1 ratio to experimental group and control group, while experimental group received nurse-led multidisciplinary precision care and the control group received standard care according to guidelines. The primary and secondary outcomes were evaluated and analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multidisciplinary precision care group | Experimental | Other: multidisciplinary precision careGive the intervention of nurse-led multidisciplinary precision care |
| control group | No intervention | –standard care according to guidelines |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged from 18 to 80 years;
- Conscious, with normal cognitive function and being communicable;
- NYHA heart function class II-IV;
- Patients met the diagnostic criteria of the clinical guidelines for the diagnosis and treatment of heart failure and were diagnosed with chronic heart failure;
- Informed consent was obtained.
Key exclusion criteria (5 listed)
- Patients with congenital heart disease, cardiac shock, or persistent hypotension;
- Patients with severe liver and kidney dysfunction, moderate to severe anemia or coagulation disorders, and other serious systemic complications;
- Patients with a history of mental illness, a state of severe anxiety or depression, cognitive or communication impairments, and inability to communicate and respond to investigations;
- Patients have been involved in other research that would interfere with this study;
- Patients who declined cardiac rehabilitation and signed informed consent.
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 |
|---|---|---|
| multidisciplinary precision careThe experimental group received precision nursing based on a multidisciplinary collaborative team in addition to standard treatment and care | Other | multidisciplinary precision care group |
Primary outcome
left ventricular ejection fraction
Time frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
6-minute walking distance
Time frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
4 secondary outcomes
the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life (QoL) questionnaires (QLQ) QLQ-C30 (version 3.0) score Quality of Life
Time frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Symptom Check List-90
Time frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Performance Status Score
Time frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Numbers of patients with cardiovascular complications
Time frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Xiuxian Zhu study chair
Zhongshan People's Hospital, Guangdong, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multidisciplinary precision care in people with Nurse's Role and Multidisciplinary Communication, run by Zhongshan People's Hospital, Guangdong, China at 1 site in China.
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 5 inclusion and 5 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 14 Aug 2023. 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 China. 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?
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?
left ventricular ejection fraction (time frame: baseline, pre-intervention, 1 month after intervention, 3 months after intervention). The study lists 2 primary outcomes in all. 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 14 Aug 2023.