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

NCT06418555 | Completed DMC

• 1 other identifier: 2023-0921
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortic Stenosis

Keywords

Cardiac Rehabilitation; Extended Care; Aortic Stenosis; TAVR

Outcome Measures

Primary Outcomes (1)

• Home-based cardiac rehabilitation exercise adherence

  Measured at the time of the patient's follow-up visit to the clinic

  After surgery, and 3 months after discharge

Secondary Outcomes (4)

• Modified Barthel Index

  After surgery, and 3 months after discharge

• Minnesota Living with Heart Failure questionnaire

  After surgery, and 3 months after discharge

• Tilburg Frailty Indicator

  After surgery, and 3 months after discharge

• Postoperative related complications

  After surgery, and 3 months after discharge

Study Arms (2)

Home Rehabilitation Team

EXPERIMENTAL

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

Behavioral: A home rehabilitation program centered on exercise

Routine care group

EXPERIMENTAL

Routine care

Behavioral: A home rehabilitation program centered on exercise

Interventions

A home rehabilitation program centered on exercise 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.

Home Rehabilitation Team; Routine care group

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Yingying Jia

Zhejiang, Zhejiang, 310000, China

Location

Related Publications (1)

• 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.

  PMID: 39657845 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Yingying Jia

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: January 18, 2024
• Primary Completion: August 10, 2024
• Study Completion: August 10, 2024
• Last Updated: February 24, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)