Chronic Heart FailureNCT06759987
Construction and Application of a Self-Care Behavior Intervention Scheme for Chronic Heart Failure Patients Based on Interaction Model of Client Health Behavior
A study testing self-care behavior intervention in people with Chronic Heart Failure and Self-care, run by Zhi-fen Feng at 1 site in China.
Trial summary
The purpose of this study, which will last for 3 months, is to investigate the effect of the intervention based on the interaction model of health behavior on patients' disease perception, heart failure self-care level, quality of life and service satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Self-care, Health Education
- What is being tested?
- self-care behavior intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with CHF according to the New York Heart Association (NYHA) functional classification of II-III.
- Age ≥ 18 years, stable condition, clear consciousness, normal language and written expression abilities, no communication barriers, able to understand and accurately complete questionnaires.
- Informed consent and voluntary participation.
Who cannot join
- -Patients with complications such as renal or hepatic insufficiency, a history of mental disorders, or currently experiencing mental disorders, or critically ill.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Nursing and Health, School of Nursing and Health,Henan University
Kaifeng, Henan, 475004
About this study
The purpose of this study, which will last for 3 months, is to investigate the effect of the intervention based on the interaction model of health behavior on patients' disease perception, heart failure self-care level, quality of life and service satisfaction. If you have any questions or difficulties, you can withdraw from this study at any time, which will not affect your treatment and care; The purpose of this study is to improve your level of self-care, prevent your readmission to the hospital, and do not harm your physical and mental health, nor negatively affect the patient's relationship with care; Your participation in the study and the personal data in the study are confidential, and any public report on the results of this study will not disclose your personal identity.
- Conditions
- Chronic Heart Failure, Self-care, Health Education
- Being tested
- self-care behavior intervention
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-care behavior interventionBehavioural
The intervention group received the self-care behavior intervention program based on the interaction model of health behavior
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | The control group received routine care. |
| intervention group | Experimental | The intervention group received the self-care behavior intervention program based on the interaction model of health behavior. Receives: Behavioral: self-care behavior intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese Version of the Self-Care of Heart Failure Index (SCHFI)
Measured: Baseline, one month and three months
Secondary outcomes (2)
Brief Illness Perception Questionnaire (BIPQ)
Measured: Baseline, one month and three months
Minnesota Living with Heart Failure Quality of Life Questionnaire (MLHFQ)
Measured: Baseline, one month and three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Jan 2023
- Primary completion30 Jun 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhi-fen Feng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhi-fen Feng, Henan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759987
- Sponsor's protocol ID
- HUSOM2023-441
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- 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 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Application of a Self-Care Behavior Intervention Scheme for Chronic Heart Failure Patients Based on Interaction Model of Client Health Behavior
- ClinicalTrials.gov ID
- NCT06759987
- Acronym / sponsor ID
- HUSOM2023-441
- Conditions
- Chronic Heart Failure, Self-care, Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zhi-fen FengUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 6 Jan 2025 (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.
The purpose of this study, which will last for 3 months, is to investigate the effect of the intervention based on the interaction model of health behavior on patients' disease perception, heart failure self-care level, quality of life and service satisfaction. If you have any questions or difficulties, you can withdraw from this study at any time, which will not affect your treatment and care; The purpose of this study is to improve your level of self-care, prevent your readmission to the hospital, and do not harm your physical and mental health, nor negatively affect the patient's relationship with care; Your participation in the study and the personal data in the study are confidential, and any public report on the results of this study will not disclose your personal identity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –The control group received routine care. |
| intervention group | Experimental | Behavioral: self-care behavior interventionThe intervention group received the self-care behavior intervention program based on the interaction model of health behavior. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with CHF according to the New York Heart Association (NYHA) functional classification of II-III.
- Age ≥ 18 years, stable condition, clear consciousness, normal language and written expression abilities, no communication barriers, able to understand and accurately complete questionnaires.
- Informed consent and voluntary participation.
Key exclusion criteria (1 listed)
- -Patients with complications such as renal or hepatic insufficiency, a history of mental disorders, or currently experiencing mental disorders, or critically ill.
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 |
|---|---|---|
| self-care behavior interventionThe intervention group received the self-care behavior intervention program based on the interaction model of health behavior | Behavioural | intervention group |
Primary outcome
Chinese Version of the Self-Care of Heart Failure Index (SCHFI)
Time frame: Baseline, one month and three months
2 secondary outcomes
Brief Illness Perception Questionnaire (BIPQ)
Time frame: Baseline, one month and three months
Minnesota Living with Heart Failure Quality of Life Questionnaire (MLHFQ)
Time frame: Baseline, one month and three months
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 6 Jan 2025.
- 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.
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?
A study testing self-care behavior intervention in people with Chronic Heart Failure and Self-care, run by Zhi-fen Feng 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 3 inclusion and 1 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 6 Jan 2025. 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?
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?
Chinese Version of the Self-Care of Heart Failure Index (SCHFI) (time frame: Baseline, one month and three months). 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 6 Jan 2025.