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

The Effectiveness of a Digital Home-based Cardiac Rehabilitation Program for TAVR Patients Based: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06418555
Enrollment
70
Registered
2024-05-17
Start date
2024-01-18
Completion date
2024-08-10
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Keywords

Cardiac Rehabilitation, Extended Care, Aortic Stenosis, TAVR

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.

Detailed description

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.

Interventions

BEHAVIORALA 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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Home-based cardiac rehabilitation exercise adherenceAfter surgery, and 3 months after dischargeMeasured at the time of the patient's follow-up visit to the clinic

Secondary

MeasureTime frameDescription
Modified Barthel IndexAfter surgery, and 3 months after dischargeMeasured at the time of the patient's follow-up visit to the clinic
Minnesota Living with Heart Failure questionnaireAfter surgery, and 3 months after dischargeMeasured at the time of the patient's follow-up visit to the clinic
Tilburg Frailty IndicatorAfter surgery, and 3 months after dischargeMeasured at the time of the patient's follow-up visit to the clinic
Postoperative related complicationsAfter surgery, and 3 months after dischargeMeasured at the time of the patient's follow-up visit to the clinic

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026