## Protocol Section
### Identification Module
**NCT ID:** NCT06418555

**Brief Title:** Construction and Application Research of Home Cardiac Rehabilitation Plan for Patients Undergoing Transcatheter Aortic Valve Replacement Based on Mobile Healthcare

**Official Title:** The Effectiveness of a Digital Home Rehabilitation Program for TAVR Patients Based on Instant Information Intervention: a Randomized Controlled Trial

#### Organization Study ID Info
**ID:** 2023-0921
#### Organization
**Class:** OTHER
**Full Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University
### Status Module
#### Completion Date
**Date:** 2024-10-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Second Affiliated Hospital, School of Medicine, Zhejiang University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Transcatheter Aortic Valve Replacement Surgery

**Keywords:**

- Transcatheter Aortic Valve Replacement

- Cardiac Rehabilitation

- Extended Care

- instant message intervention

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 70

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Behavioral: A home rehabilitation program centered on exercise

**Label:** Home Rehabilitation Team

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Routine care

**Intervention Names:**

- Behavioral: A home rehabilitation program centered on exercise

**Label:** Routine care group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Home Rehabilitation Team

- Routine care group

**Description:** 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.

**Name:** A home rehabilitation program centered on exercise

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Six minute walking distance

**Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge

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

**Measure:** Home-based cardiac rehabilitation exercise adherence

**Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge

#### Secondary Outcomes

**Description:** Katz activities of daily living，Katz-ADL

**Measure:** KATZ

**Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge

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

**Measure:** Barthel index

**Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge

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

**Measure:** Grip(kg)

**Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge

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

**Measure:** KCCQ

**Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge

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

**Measure:** death

**Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge

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

**Measure:** Postoperative related complications

**Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge

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

**Measure:** readmission rate

**Time Frame:** After surgery, 1 month after discharge, and 3 months after discharge

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Postoperative TAVR patients are 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.

**Healthy Volunteers:** True

**Maximum Age:** 100 Years

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zrxwk1@zju.edu.cn

**Name:** jianping song

**Phone:** 13757119617

**Role:** CONTACT

**Contact 2:**

**Email:** 22218917@zju.edu.cn

**Name:** Yingying Jia

**Phone:** 18298437245

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Zhejiang

**Contacts:**

***Contact 1:***

- **Email:** zrxwk1@zju.edu.cn

- **Name:** jianping song

- **Phone:** 13757119617

- **Role:** CONTACT

**Country:** China

**Facility:** Yingying Jia

**State:** Zhe Jiang

**Status:** RECRUITING

**Zip:** 310000

#### Overall Officials

**Official 1:**

**Affiliation:** Second Affiliated Hospital, School of Medicine, Zhejiang University

**Name:** Yingying Jia

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
