Clinical trial NCT06418555: Construction and Application Plan of Home Cardiac Rehabilitation for Patients Undergoing TAVR
Official title: The Effectiveness of a Digital Home-based Cardiac Rehabilitation Program for TAVR Patients Based: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Stenosis
Keywords: Cardiac Rehabilitation
Extended Care
Aortic Stenosis
TAVR
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Home-based cardiac rehabilitation exercise adherence
timeFrame: After surgery, and 3 months after discharge
Secondary outcomes:
measure: Modified Barthel Index
timeFrame: After surgery, and 3 months after discharge
measure: Minnesota Living with Heart Failure questionnaire
timeFrame: After surgery, and 3 months after discharge
measure: Tilburg Frailty Indicator
timeFrame: After surgery, and 3 months after discharge
measure: Postoperative related complications
timeFrame: After surgery, and 3 months after discharge
Other outcomes:
Locations:
city: Zhejiang
country: China
facility: Yingying Jia
state: zhe jiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Yingying Jia
role: STUDY_DIRECTOR
References: