Exploratory Study of the Usability, Feasibility, and Perception for Tele-cardiac Rehabilitation (Tele-CR) Program

NCT06816693 | Completed

• 1 other identifier: 202301928B0
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this mixed prospective observational and qualitative studies is to evaluate the usability of a newly developed application (App) and the feasibility and perception of a 12 weeks tele-cardiac rehabilitation (tele-CR) program. The main question it aims to answer is: Does tele-CR program intervention a acceptance feasibility in coronary heart disease patients? The findings will guide subsequent intervention design studies.

Conditions

Coronary Heart Disease; Coronary Arterial Disease (CAD)

Keywords

coronary heart disease; cardiac rehabilitation; telemedicine; mobile health

Outcome Measures

Primary Outcomes (3)

• Level of recruitment rate of tele-CR program

  The recruitment rate is a percentage calculated by dividing the number of patients who agreed to participate in the study by the number of patients who met the eligibility criteria, which can reflect the interest of CHD patients in participating in the tele-CR program. The recruitment rate is calculated when the number of sample collections of research subjects is completed.

  through study completion, an average of 8 months

• Level of engagement rate of tele-CR program

  The degree of actual operation of the App can be used to reflect the degree to engage of the tele-CR program of participants. The researchers collected data on participants' actual use of the App through the App manager's backend, including the number of times knowledge was browsed, the percentage of execution of homework records, and the number of questions asked.

  1st, 4th, 8th and 12th weeks after discharge

• Level of retention rate of tele-CR program

  The retention rate refers to the percentage of participants who have not dropped out of the study and can be kept in touch via Line or telephone. It can be used to reflect the extent to which participants remain in the -CR program and help researchers understand the feasibility of future intervention study of the tele-CR program.

  1st, 4th, 8th and 12th weeks after discharge

Secondary Outcomes (4)

• Level of acceptance of App and management platform

  4th and 12th weeks after discharge

• Level of usability of App and management platform

  4th and 12th weeks after discharge

• Level of satisfaction of App and management platform

  4th and 12th weeks after discharge

• Qualitative feedback perception on tele-CR program

  8th weeks after discharge

Study Arms (1)

A tele-CR program was implemented for all participants

A 12 weeks tele-CR program was implemented for all participants.

Behavioral: tele-CR program

Interventions

tele-CR program BEHAVIORAL

Following the completion of basic characteristics assessment prior to discharge, a 12 weeks tele-CR program was implemented for all participants. The tele-CR program is divided into three parts: motivational interview, App delivery, and self-management and tracking. The motivational interviewing during hospitalization, which involved evaluating individual risk factors, setting behavioral goals, and providing training on the installation and operation of the tele-CR App (approximately 30-60 minutes per session). After discharge, the researchers monitored App usage and conducted four follow-up sessions via LINE or telephone at 1, 4, 8, and 12 weeks post-discharge. These follow-ups, lasting approximately 5-15 minutes each, aimed to assess patients' living conditions, resolve any issues promptly, and provide encouragement or praise based on their engagement with the App.

A tele-CR program was implemented for all participants

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the hospital with a primary diagnosis of CHD will be conducted. We plan to recruit a group of patients to receive the tele-CR program and evaluate the usability of the App perceived by patients at 1 and 3 months after discharge. Therefore, we use the t-test (one sample case) statistical method and set the effect size to a moderate 0.5, power is 0.8, alpha is 0.05 (two-tailed), and the number of samples required after calculation using G\*power 3.1 software is 34. Considering the 20% attrition rate, we estimate that we will recruit 45 cases (quantitative). The number of samples for qualitative research is mainly to achieve data saturation, and according to the literature, it is recommended to have at least 12 people.

You may qualify if:

• The main diagnosis at admission of CHD.
• Age ≥20 years.
• Owns an iOS or Android smartphone and can use it.
• Conscious, clear and can communicate.
• Agrees to participate in the research after explanation and is willing to use the App.

You may not qualify if:

• Level IV on the New York Heart Association Functional Classification.
• Left ventricular ejection fraction≦40%.
• Have a history of severe arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation, complete atrioventricular block).
• Combined with other serious heart diseases (e.g., congenital heart disease, cardiomyopathy).
• Mental disorders, end-stage renal disease and other systemic diseases diagnosed by a physician.
• Severe infection, injury, surgery (e.g., coronary artery bypass graft) or cancer treatment has occurred in the past three months.
• Physical activities are affected by neurological, respiratory, skeletal, or peripheral vascular diseases.
• Restricted use of the App due to sensory or cognitive impairment.
• Already participated in other clinical trials.
• Planning to receive surgery (e.g., coronary artery bypass graft).

Sponsors & Collaborators

• Chang Gung University of Science and Technology: lead
• Chang Gung University: collaborator
• Chang Gung Memorial Hospital: collaborator
• National Science and Technology Council: collaborator

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Guishan Dist., 333, Taiwan

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Ching-Ching Tsai, Associated Professor

  Chang Gung University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 10, 2025
• Study Start: March 31, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)