Chronic Heart FailureNCT06779227
Implementation and Evaluation of Hospital-to-Home Transitional Care Intervention in Patients with Chronic Heart Failure
A study testing Hospital family transitional nursing intervention in people with Chronic Heart Failure, run by Zhi-fen Feng at 1 site in China.
Trial summary
This study lasted for a total of three months. The purpose is to build a hospital-family transitional nursing intervention program for patients with chronic heart failure, and to explore the effectiveness of the program on the self-management of patients with chronic heart failure, in order to provide certain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Hospital family transitional nursing intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2021to 25 Dec 2022
- 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
- It meets the diagnostic criteria of the New York Heart Association (NYHA) for CHF, and the heart function level is II to III;
- Age ≥18 years old;
- The condition is stable and meets the standard of being discharged from the hospital;
- Clear consciousness, no communication barriers, able to understand and fill in the questionnaire correctly;
- Informed consent and voluntary participation in this study.
Who cannot join
- Patients with hepato-renal disfunction, sequelae of stroke, dementia;
- Patients with a history of mental disorders or already having mental disorders, critically ill patients.
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
Official title: Implementation Ond Evaluation of Hospital-to-Home Transitional Care Intervention in Patients with Chronic Heart Failure
This study lasted for a total of three months. The purpose is to build a hospital-family transitional nursing intervention program for patients with chronic heart failure, and to explore the effectiveness of the program on the self-management of patients with chronic heart failure, in order to provide certain empirical research for the clinical intervention of transitional nursing for patients with chronic heart failure. If you have any questions or difficulties, you can withdraw from this study at any time, which will not affect your treatment and nursing. The purpose of this study is to improve your self-care level and prevent your re-admission. It will not harm your physical and mental health and will not have a negative impact on the relationship between patients and nursing. You participate in this study and The personal data in the study is confidential, and any public report on the results of this study will not disclose your personal identity.
- Conditions
- Chronic Heart Failure
- Being tested
- Hospital family transitional nursing intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital family transitional nursing interventionBehavioural
The intervention group received a transitional care intervention mainly focused on the transitional care model (TCM).
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | The control group received routine care. |
| Intervention group | Experimental | The intervention group received a transitional care intervention mainly focused on the transitional care model (TCM). Receives: Behavioral: Hospital family transitional nursing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy management indicators
The measurement tool adopts the Chronic Disease Self-Efficacy Questionnaire compiled by Stanford University in the United States.The scoring consists of two dimensions: symptom management and disease-commonality management. The self-efficacy score for symptom management is calculated by averaging items 1, 2, 3, and 4 (if two or more items are missing or omitted, the variable is considered missing). A higher score indicates greater self-efficacy in symptom management. The self-efficacy score for disease-commonality management is obtained by averaging items 5 and 6. The score ranges from 1 to 5, a higher score indicates higher self-efficacy in disease-commonality management.
Measured: Baseline, one month, three months
Secondary outcomes (3)
Self-care indicators
In this study, the Chinese version of the self-care ability scale for elderly, translated by Guo , was used. The scale demonstrates good reliability and validity, with a Cronbach's α coefficient of 0.82, a test-retest reliability of 0.82, and a content validity index of 0.94. The scale consists of 17 items and is applicable to all older adults. Scoring on the scale ranges from "completely disagree" to "completely agree," with scores ranging from 1 to 5. Higher scores indicate a higher self-care ability in older adults.
Measured: Baseline, one month, three months
Disease-related indicators
Disease-related indicators are the indicators of frequent examination of patients with heart failure in the hospital: The blood test index adopts NT-proBNP as a measurement indicator, which is an independent risk factor for the death and re-admission of patients with heart failure. Due to structure and metabolism, NT-pro BNP has the advantages of long half-life (120min), high blood concentration, low individual variability rate, good in vitro stability, not limited by specimen collection conditions and the influence of specimen type (plasma or serum). NT-pro BNP testing on patients can help assess long-term risks. Repeated determination will provide more prognostic information for patients.
Measured: Baseline, one month, three months
Transitional nursing evaluation indicators
This study adopts the Care Transitions Measure (CTM-15) developed by American scholar COLEMAN in 2002. This scale is a self-assessment scale that evaluates transitional care from the patient's perspective, including information transmission ( 6 items), patient participation (3 entries), management preparation (4 entries), nursing plan (2 entries) 4 dimensions, a total of 15 entries. The results show that the total scale Cronbach's α coefficient is 0.93, and the content validity index is 0.99, which has good credibility. The scores of each item: "very disagree", "disagree", "agree" and "very agree" are 1~4 points respectively, and the final score is converted to 0~100 points. The higher the score, indicating that the research subjects are satisfied with the transitional nursing services.
Measured: Baseline, one month, three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start15 Oct 2021
- Primary completion20 Jun 2022
- Study completion25 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 60 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
- NCT06779227
- Sponsor's protocol ID
- HUSOM2021-289
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feng ZF, Liu Y, Salvador JT, Ala MB, Nery MAC, Huang XY, Zhang L, Liu S. Implementation and evaluation of hospital-to-home transitional care intervention in patients with chronic heart failure. BMC Nurs. 2025 Jul 1;24(1):717. doi: 10.1186/s12912-025-03447-5.
PubMed 40597265
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Ond Evaluation of Hospital-to-Home Transitional Care Intervention in Patients with Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT06779227
- Acronym / sponsor ID
- HUSOM2021-289
- Conditions
- Chronic Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zhi-fen FengUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 25 Dec 2022 (actual)
- First posted
- 16 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.
This study lasted for a total of three months. The purpose is to build a hospital-family transitional nursing intervention program for patients with chronic heart failure, and to explore the effectiveness of the program on the self-management of patients with chronic heart failure, in order to provide certain empirical research for the clinical intervention of transitional nursing for patients with chronic heart failure. If you have any questions or difficulties, you can withdraw from this study at any time, which will not affect your treatment and nursing. The purpose of this study is to improve your self-care level and prevent your re-admission. It will not harm your physical and mental health and will not have a negative impact on the relationship between patients and nursing. You participate in this study and The personal data in the study is 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: Hospital family transitional nursing interventionThe intervention group received a transitional care intervention mainly focused on the transitional care model (TCM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- It meets the diagnostic criteria of the New York Heart Association (NYHA) for CHF, and the heart function level is II to III;
- Age ≥18 years old;
- The condition is stable and meets the standard of being discharged from the hospital;
- Clear consciousness, no communication barriers, able to understand and fill in the questionnaire correctly;
- Informed consent and voluntary participation in this study.
Key exclusion criteria (2 listed)
- Patients with hepato-renal disfunction, sequelae of stroke, dementia;
- Patients with a history of mental disorders or already having mental disorders, critically ill patients.
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 |
|---|---|---|
| Hospital family transitional nursing interventionThe intervention group received a transitional care intervention mainly focused on the transitional care model (TCM). | Behavioural | Intervention group |
Primary outcome
Self-efficacy management indicators
Time frame: Baseline, one month, three months
The measurement tool adopts the Chronic Disease Self-Efficacy Questionnaire compiled by Stanford University in the United States.The scoring consists of two dimensions: symptom management and disease-commonality management. The self-efficacy score for symptom management is calculated by averaging items 1, 2, 3, and 4 (if two or more items are missing or omitted, the variable is considered missing). A higher score indicates greater self-efficacy in symptom management. The self-efficacy score for disease-commonality management is obtained by averaging items 5 and 6. The score ranges from 1 to 5, a higher score indicates higher self-efficacy in disease-commonality management.
3 secondary outcomes
Self-care indicators
Time frame: Baseline, one month, three months
Disease-related indicators
Time frame: Baseline, one month, three months
Transitional nursing evaluation indicators
Time frame: Baseline, one month, 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 16 Jan 2025.
- Derived from this study: PubMed 40597265Feng ZF, Liu Y, Salvador JT, Ala MB, Nery MAC, Huang XY, Zhang L, Liu S. Implementation and evaluation of hospital-to-home transitional care intervention in patients with chronic heart failure. BMC Nurs. 2025 Jul 1;24(1):717. doi: 10.1186/s12912-025-03447-5.
- Individual participant dataSharing planned: No
Related trials for Chronic Heart Failure
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients
Hypotension
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 Hospital family transitional nursing intervention in people with Chronic Heart Failure, 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 5 inclusion and 2 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 16 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?
Self-efficacy management indicators (time frame: Baseline, one month, three months). 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 NCT06779227, which also lists 1 linked publication.
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 16 Jan 2025.