Effectiveness of Home-Based Cardiac Rehabilitation

Objectives of Study H01: There is a significant difference in the quality of life and health behavior of patients with cardiovascular diseases who will receive usual care with and without HBCR.

H02: There is a significant difference in the frequency of emergency hospital visits of patients with cardiovascular diseases who will receive usual care with and without HBCR Significance of Study Benefits for the Development of Knowledge This research has the potential to provide significant contributions to the development of the knowledge in the field of health sector specially nursing and cardiology and public health. This study may encourage the development of the Home based cardiac rehabilitation and may encourage to provide accessible and affordable health care services. Home-based cardiac rehabilitation (HBCR) is a research-based intervention to improve quality of life and health behavior, preventing cardiovascular diseases. It will be significant, as its findings will bring results to improve home-based nursing care for the improvement of life and behavior of cardiac patients. Besides, this research enhances the comprehensive strategy to understand the differences and similarities in applying HBCR model in various cultures and regions.

Benefits to the Community This study provides direct benefits to the community especially to rural health of how resource settings which need awareness, cost effective, accessible and affordable health care services. Families and patients will be able to manage their cardiac health by controlling risk factors and changing life styles that affect cardiac health.

Benefits for Policymakers This research will be able to provide opportunity to policy makers at local and regional level to devise strategies and policies based on scientific evidence to provide cardiac health care services to the low resource settings. The results of this study will also be shared with key stakeholders associated with nursing and health policy-making subjects, such as the Pakistan Nursing \& Midwifery Council and health ministry at the national and provincial levels. This will help in identifying the needs that could meet the standards and protocols of home-based cardiac rehabilitation and changes in curriculum of nursing education focusing cardiac health.

Benefits to the Country Home based Cardiac rehabilitation will improve quality of life and reduce healthcare expenditure burden of the country. The exercise component of the intervention of HBCR will provide significant physiological positive outcomes, including increased maximal oxygen uptake (VO2 max), normal endothelial functioning, and improved myocardial capability to function. Besides, cardiac rehabilitation will help in reductions in smoking, lowering body weight, improving serum lipids, and blood pressure. A Cochrane review found that cardiac rehabilitation reduced hospital admissions and impacted to a long-term reduction in all-cause mortality in patients with heart failure and preserved ejection fraction, though no short-term (\<12 months) mortality benefit was observed. Besides, reduced burden of admissions and expenditure on the hospital.

Scope of Study This research study is conducted 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, Pakistan. Patients diagnosed with cardiovascular disease will be included as the target population in this study. The scope of this study will be to analyze the effectiveness of home-based cardiac rehabilitation to improve the quality of life and behavior of patients with cardiovascular diseases in low-resource settings, Islamabad, Pakistan.

Study Design Randomized controlled trial (RCTs) is the study and considered the appropriate level of studies that are evidence based and establish causal relationships in clinical research.

The applicability of this interventional study design is effective for prospective data collection, investigator-controlled intervention, usage of a concomitant control group, and randomizing to balance clear and latent confounding factors. Therefore, randomized controlled trial design will be more effective in this rigorous in improving positive outcomes of health by evaluating the effectiveness of home-based cardiac rehabilitation to improve the quality of life and behavior of the patients.

Study Setting The study will be conducted at the cardiac center of Pakistan Institute of Medical Sciences, Islamabad, which is a research-oriented health sciences institute located in Islamabad, Pakistan. It is one of the region's leading tertiary-level hospitals and teaching institutes, which includes both clinical and supporting services. It is almost a 1000-bed hospital that included medical, surgical, cardiac, gynecological, ENT, and burn care centers. PIMS hospital is the only hospital providing hospital based cardiac rehabilitation services to the population of Islamabad, Rawalpindi, Kashmir, and KPK.

The Cardiac Centre of the PIMS hospital is the only center in Islamabad among five tertiary hospitals that provides cardiac health services, including emergency medicine, surgical and diagnostic care, and operative cure and care. Therefore, the purpose of selecting this setting seemed to be appropriate for conducting this research study. Islamabad is the capital city of Pakistan and is located within the federal Islamabad Capital Territory. The population of this cosmopolitan city is more diverse and multi cultured.

Study Population Research Population The increased burden of CVD has become a serious health concern in Pakistan. Recent reports from Pakistan indicate higher rate of CVDs in the young population. Cardiovascular patients are assessed inaccurately, and their condition is misinterpreted resulting in appropriate medications leading to the older populations at the risk in cardiac management affecting their quality of life. Therefore, the patients more than 18 years age diagnosed with cardiovascular diseases based on diagnosis and clinical history including Electric Cardiogram, non-invasive tests like, echocardiography, exercise tolerance test (ETT), Thallium stress test, biochemical markers, and selected for procalcitonin PCI, a biomarker for the diagnosis of the infection in the heart. Patients discharged from the hospital by the consultant will be included for the research study.

Sample Size Calculation Sample size calculation is instrumental at the planning phase which make sure that there are sufficient and appropriate number of samples for provision of the reliable and accurate assessment of the drug items with certain statistical assurance. The purpose of sample size estimation is to plan sufficient figures of subjects for designed study design. Sample size planning is considered suitable strategy of calculating study subjects in mathematical manner of making a ballpark estimate. Sample size planning is considered essential for both analytic and descriptive study design, and the planning for estimation of sample size should earlier during the procedure of developing the research design so that appropriate modifications and can be made. Hence, the sample size is calculated on G Power software based on an expected moderate effect size of 0.59 to assess the effectiveness of home-based cardiac rehabilitation to improve the quality of life of cardiovascular patients in low- resource settings.

The following parameters were used for sample size calculation:

Assumptions:

* Effect size (Partial eta squared): 0.59 * Significance level (α): 0.05 (two-tailed) * Power (1 - β): 0.80 (80%) * Allocation ratio: 1:1 (equal participants in both groups) * Dropout rate: 20%

The sample size per group is calculated using the following formula for comparing two independent means:

Therefore, the required sample size is approximately 46 participants per group (before adjusting for dropout).

To account for a 20% dropout rate:

Adjusted sample size per group = n / (1 - dropout rate) Adjusted n = 46 / (1 - 0.20) Adjusted n = 46 / 0.80 Adjusted n = 57.5 ≈ 58 participants per group Final total sample size = 58 (intervention) + 58 (control) = 116 participants Thus, a total of 116 participants (58 in each group) will be required to detect an effect size of 0.59 with 80% power and 5% significance level, accounting for a 20% dropout rate.

Randomization In clinical trials, statistical inference is a compulsory process to testify potency, efficacy and safety of drugs, procedures and medical devices, allowing generalization of the results observed through sampling process. Randomization is the allocation technique applied for study participants to study groups by chance Participants will be randomly assigned to either the hone based cardiac rehabilitation group or to the control group of routine/ standard care using a computer-generated sequence. Simple randomization can be adopted using technique of sealed envelopes during the sampling process. This strategy consists of a group assignment (with a new envelope being opened on enrollment of as each patient), or application of randomization software for randomization process. However, there is rare usage of sealed envelopes considering potential risks for investigator manipulation (Piantadosi, 2024). For instance, chronological bias, which cannot be ignored if there was recruitment of the study participants mismatched, and one group recruited earlier in the control group and/or the majority of those in the treatment group were recruited later. Restrictive randomization technique is effective to resolve the imbalance in simple randomization This simple strategy of randomization is suggested for large sample size in large-scale clinical trial studies because the possibility of imbalance in trials with a small number of samples is higher. Blocking is one of the effective strategies employed in the RCTs. In short block randomization is a technique that ensures that there is relatively equal number of study participants in each cohort. Block randomization has the advantage, which increases comparability between two groups by keeping the ratio of the number of study participants between cohorts almost similar. Therefore, the permuted- block randomization sampling technique will be adopted in this study. Blocking is technique of restricted randomization that maintains balance between the two sets at the end of every block. Technique of sealed envelope will be applied to allocate each study participants into either usual care or cardiac rehabilitation.

Selection of Criteria Inclusion Criteria

The study participants who will be included in the study who have been:

* 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. * Showed participation willingly and signed informed consent form * Accessible to mobile phone communication or any other source of communication * Resident of the surrounding areas other than the sectors of Islamabad as defined by the Capital Development Authority (CDA) of Pakistan.

Exclusion Criteria:

* Patients who have been diagnosed with comorbidity of psychiatric disorder or cognitive impairment * Individuals with specific cardiac conditions or treatments, such as heart valve replacement, heart failure, or atrial fibrillation, or those with implanted cardiac devices like CRT or ICD.

Randomization and Allocation Participants will be randomly assigned to Intervention Group (HBCR): Will receive a structured home-based cardiac rehabi