Construction and Application Plan of Home Cardiac Rehabilitation for Patients Undergoing TAVR

NCT ID: NCT06418555

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-18

Study Completion Date

2024-08-10

Brief Summary

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Cardiac rehabilitation is a long-term process, but patients have poor compliance with cardiac rehabilitation. The theory of behavior change rotation aims to comprehensively intervene from three aspects: ability, opportunity, and motivation, promoting individual behavior change by selecting the best intervention function and maximizing the use of available resources. To improve the compliance of TAVR patients with digital home cardiac rehabilitation, this study is based on the needs of TAVR patients and their caregivers for digital home cardiac rehabilitation. Based on the best evidence summary of TAVR patients' home cardiac rehabilitation, a home cardiac rehabilitation plan for TAVR patients is constructed using the theory of behavior change wheels. The Delphi method is used to revise the plan, develop a TAVR patient home cardiac rehabilitation management system, and conduct clinical application research on the plan to explore the intervention effect of TAVR patients' home cardiac rehabilitation based on real-time information intervention.

Detailed Description

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Conduct home cardiac rehabilitation assessment 1-6 days before discharge; In the first week after discharge, cultivate the patient's motivation for rehabilitation; In the second week after discharge, create a home rehabilitation environment; In the third week after discharge, health education on risk factor management; Health education on anticoagulation management in the fourth week after discharge; 5 weeks after discharge, home symptom and follow-up management education; Carry out home exercise and monitoring from 1 to 12 weeks after discharge.

Conditions

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Aortic Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Home Rehabilitation Team

Adding an immediate information-based intervention to the routine home care intervention with a home cardiac rehabilitation program intervention for TAVR patients.

Group Type EXPERIMENTAL

A home rehabilitation program centered on exercise

Intervention Type BEHAVIORAL

Establish a multidisciplinary team, with team members combining clinical experience, summarizing the best evidence as the basis, and using the theory of behavior change wheels as the framework, to preliminarily construct a home-based cardiac rehabilitation plan suitable for TAVR patients in China's national conditions. Conduct expert consultation using the Delphi method to form the final version of the home cardiac rehabilitation plan for TAVR patients.

Routine care group

Routine care

Group Type EXPERIMENTAL

A home rehabilitation program centered on exercise

Intervention Type BEHAVIORAL

Establish a multidisciplinary team, with team members combining clinical experience, summarizing the best evidence as the basis, and using the theory of behavior change wheels as the framework, to preliminarily construct a home-based cardiac rehabilitation plan suitable for TAVR patients in China's national conditions. Conduct expert consultation using the Delphi method to form the final version of the home cardiac rehabilitation plan for TAVR patients.

Interventions

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A home rehabilitation program centered on exercise

Establish a multidisciplinary team, with team members combining clinical experience, summarizing the best evidence as the basis, and using the theory of behavior change wheels as the framework, to preliminarily construct a home-based cardiac rehabilitation plan suitable for TAVR patients in China's national conditions. Conduct expert consultation using the Delphi method to form the final version of the home cardiac rehabilitation plan for TAVR patients.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: Patients undergoing TAVR who were classified as Grade I-III by the New York Heart Association (NYHA); Patients are able to use mobile devices such as smartphones; Patients who have obtained admission qualifications after undergoing digital home cardiac rehabilitation risk assessment by the rehabilitation team; The patient and their family members voluntarily participate in this study and are willing to provide an informed consent form; Able to use remote rehabilitation diagnosis and treatment systems Exclusion Criteria: Malignant tumors or those with serious complications; Patients with hearing and visual impairments; Patients with limited physical activity due to other diseases; Patients with obvious cognitive or mental disorders; Patients without Internet connection after returning home from hospital; Patients who have participated in or participated in other trials or rehabilitation plans within the past three months.
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yingying Jia

Role: STUDY_DIRECTOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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Yingying Jia

Zhejiang, Zhejiang, China

Site Status

Countries

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China

References

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Jia YY, Dong MQ, Feng J, Hu JN, Hu HT, Yuan TM, Song JP. The effectiveness of a nurse-led home-based cardiac rehabilitation based on instant information intervention in the prognosis of patients with TAVR: A randomized controlled trial protocol. Curr Probl Cardiol. 2025 Mar;50(3):102967. doi: 10.1016/j.cpcardiol.2024.102967. Epub 2024 Dec 8.

Reference Type DERIVED
PMID: 39657845 (View on PubMed)

Other Identifiers

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2023-0921

Identifier Type: -

Identifier Source: org_study_id

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