Effectiveness of Home-Based Cardiac Rehabilitation

NCT07290907 | Not Yet Recruiting DMC

• 1 other identifier: F-5-2/2024 ERRC
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

Statement of the Problem WHO stated that the average life expectancy has been recorded as 40 years among these in South Asian countries and 98 million people relate to Pakistan. Wang pointed out that the significant difference has been seen regarding provision of the health care facilities being provided in the rural and urban settings, called as health poverty in rural area as compared to urban areas. Therefore, accessibility of essential healthcare facilities such as experienced staff, vaccination and necessarily supply of medicines in rural population would be supporting reducing health poverty and will maintain equal and equitable opportunities. Andersen and Newman argued that there are main factors such as distance, time and travel costs that affect health accessibility for the poor people living in rural settings which are deprived of emergency care and common in developing economies. Cardiac Rehabilitation is a efficient, safe and affordable intervention that lowers overall health service financial burden. Additionally, CR are planned to optimize and restore physical, psychological, and social functioning by combining medical consultation, individualized exercise sessions, education, cardiac risk factor modification, and health counseling. CR is highly and mostly suggested as the key multicomponent and multi-dimensional intervention for the prevention of death by cardiac attacks, the lowering chances of hospital readmissions, and the enhancement of quality of life (QoL) of the people. Therefore, CR is one of the effective techniques to decrease the increasing number of cases and provide an efficient cardiac health intervention program with appropriate planning and organization. Despite the evidence of cost-effective rehabilitation program to optimize cardiac functioning at the hospital-based settings but the participation in cardiac rehabilitation, traditionally delivered in hospital outpatient departments or community, Despite the evidence of cost-effective rehabilitation program to optimize cardiac functioning at the hospital-based settings but the participation in cardiac rehabilitation, traditionally delivered in hospital outpatient departments or community centers, has remained low, with average participation rates \< 20% recorded in the United States and similarly in the Europe. Low participation has predominantly recorded mostly in few groups like women, elder population, ethnic minorities, and those living in rural settings or who are socioeconomically and financially resource constrained. Subsequently, these patients were contacted through calls for alternative options to center-based cardiac rehabilitation. Recommended interventions included cardiac rehabilitation at home transited by healthcare professionals with the support of telehealth technologies to maximize participation. Thus, the home-based cardiac rehabilitation program was recommended by the American Heart Association and the American College of Cardiology in 2019 through a scientific statement. Guidelines from NICE on chronic heart failure in the UK in 2018 said that "delivery of home-based rehabilitation may enhance the accessibility and participation. For changing behavior and improving quality of life, HBCR is an essential component of secondary prevention and an important alternative technique, for those patients who suffered a cardiac incident or experienced any other cardiac event. Hence, HBCR is one of the effective t strategies to reduce the higher number of cases. HBCR contains techniques for secondary prevention that facilitate cardiac patients to rebuild their functional cardiac capacity and decrease the magnitude of hospital visits and workload in emergency management in coronary critical areas. Most of the studies were done on cardiovascular disease and on the conventional approach of hospital-based cardiac rehabilitation, but rare literature in the context of Pakistan, especially Islamabad, was found on home-based cardiac rehabilitation to improve the quality of life and behavior of the patients. Thus, the study aims to evaluate the effectiveness of home-based cardiac rehabilitation to improve the quality of life and health behavior of patients with cardiovascular disease in low resource settings in Islamabad.

Conditions

Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Quality of life Questionnaire

  Quality of life Quality of life will be measured using validated tools such as the MacNew Quality of Life Questionnaire (description provided in study instrument section).

  Three months

• Health Behavior Change questionnaire

  Health Behavior Change Assessed using a self-reported questionnaire covering physical activity, diet, medication adherence, and smoking. Its scoring range is based on the Likert-type scale, such as 1 = never to 4 =, whereas a high score represents more quality behavior.

  Three months

Study Arms (2)

The Intervention group (Cardiac Rehabilitation Program)

EXPERIMENTAL

The Intervention group Home-based cardiac rehabilitation for the intervention group. A structured cardiac rehabilitation program will be conducted at the patient's home. This structured program will include dietary counseling, physical activity suggestions and recommendations, adherence to medications prescribed by the cardiologist, psychotherapy, and lastly telephone calls or visits at home.

Behavioral: Home-based therapy

Control group

NO INTERVENTION

The control group will receive only standard communication from the cardiologist and routine follow-up care. The control group will receive standard discharge advice and routine outpatient follow-up care as per hospital protocol, with no structured rehabilitation support.

Interventions

Home-based therapy BEHAVIORAL

A structured cardiac rehabilitation program will be conducted at the patient's home. This structured program will include dietary counseling, physical activity suggestions and recommendations, adherence to medications prescribed by the cardiologist, psychotherapy, and lastly telephone calls or visits at home.

The Intervention group (Cardiac Rehabilitation Program)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with coronary artery disease, myocardial infarction and heart failure Diagnosed with cardiovascular diseases based on clinical history and diagnosis, including electrocardiogram (ECG), biochemical markers, or non-invasive tests like, echocardiography, exercise tolerance test (ETT), Thallium stress test, and selected for procalcitonin PCI, a biomarker for the diagnosis of the infection Either gender included Found medically stable and discharged from the hospital. Resident of the surrounding areas other than the sectors of Islamabad as defined by the Capital Development Authority (CDA) of Pakistan.

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (1)

Cardiac Centre Pakistan Institute of Medical Sciences Islamabad

Islamabad, 44000, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Instructor

Model Details: The control group will receive only standard communication from the cardiologist and routine follow-up care. The control group will receive standard discharge advice and routine outpatient follow-up care as per hospital protocol, with no structured rehabilitation support. Home-based cardiac rehabilitation for the intervention group will be supervised by a multidisciplinary team such as a researcher, trained nursing staff, and cardiologist. A structured cardiac rehabilitation program will be conducted at the patient's home. This structured program will include dietary counseling, physical activity suggestions and recommendations, adherence to medications prescribed by the cardiologist, psychotherapy, and lastly telephone calls or visits at home. The time duration of the data collection will start from the baseline to the intervention, comprising 12 weeks.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 18, 2025
• Study Start: December 15, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 15, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)