ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12623000049673

Ethics application status

Approved

Date submitted

1/12/2022

Date registered

16/01/2023

Date last updated

13/06/2024

Date data sharing statement initially provided

16/01/2023

Type of registration

Prospectively registered

Titles & IDs

Public title

Home Based Cardiac Rehabilitation: Development, Implementation, and Outcome Evaluation in Patients with Coronary Artery Diseases in Lahore, Pakistan. A Mixed Methods Study

Scientific title

Home Based Cardiac Rehabilitation: Development, Implementation, and Outcome Evaluation in Patients with Coronary Artery Diseases in Lahore, Pakistan. A Mixed Methods Study

Secondary ID [1]

‘Nil known’

Universal Trial Number (UTN)

U1111-1285-6491

Trial acronym

HBCR-DIOE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acute Coronary Artery Diseases

Heart Related Anxiety

Hypertension

Diabetes Mellitus

Obesity

Condition category

Condition code

Cardiovascular

Coronary heart disease

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Phase 1
In this phase, a few hours after the procedure, patients’ capacity to mobilize, risk factors and education, and possible facilitation into the program will be assessed. Furthermore, the researcher will initiate phase 1 by examining the cardiac risk factors for all eligible patients by blood pressure, heart rate, New York Heart Association (NYHA) Classification for dyspnea, and present symptoms. Along with that, the patient’s cognitive function, readiness for a lifestyle change, and overall health needs will also be evaluated. The complete assessment will be done in approximately 1 hour during hospitalization, at a private room in the hospital. Few hours after the event or procedure is a critical window in which patients often feel highly motivated to initiate lifestyle changes.
Phases 2 and 3
Phase 2 includes functional capacity, physical activity and exercise, risk-factor modification, tobacco/smoking cessation, nutritional guidance, psychological counseling, and medication adherence. Before entering into this phase, a submaximal exercise test; the 6-minute Walk Test (6MWT) will be used as qualifying as well as for initiating the exercise prescription. The minimum distance required to qualify will be 150 meters for non-surgical patients (Rohrbach, 2017). The 6MWT will be performed at first follow-up i.e. within 7 days after the procedure in a hospital setting for patients with stable angina, post Percutaneous Coronary Intervention (PCI), and with following myocardial infarction. On the same visit, each patient in the HBCR Group will receive a hard copy of booklet as a guide to physical activity and exercise, strategies for risk-factor modification, nutritional guidance, and the importance of medication adherence. The booklet will be developed specifically for this study by exploring experiences and Opinions from the patients and experts, respectively. An electronic/soft copy of booklet (pdf) will also be shared on their WhatsApp number. A reminder through a text message will be given every week to ensure their compliance with the educational module.
Additionally, a structured personal health journal will be developed and provided to document daily activities such as blood pressure, heart rate, physical activity, and dietary intake.
After subsequent assessment and enrollment into phase two, patients will be followed physically in the clinics on their scheduled appointment/follow-up i.e at 1 week, 4 week, 8 week, and 12 week post-discharge and will be compensated for these visits. The topics mentioned in the handbook will be covered in these sessions and they will also be taught about self-monitoring the exercise with a targeted heart rate between 60%-75% and Borg dyspnea scale for perceived exertion, respectively. The aim is to achieve a minimum 150 minutes of moderate activity level each week as determined by a targeted heart rate between 60%-75% and Borg dyspnea scale for perceived exertion. The targeted heart rate will be calculated by the researcher for the individual patient. The patients will be taught to take caution and stop physical activity/exercise if they feel chest discomfort, chest pain, unexpected Shortness of breath, nausea, dizziness, palpitations, excess sweating, or feeling of being unwell.
For the risk-factor modification, patients will be motivated to avoid smoking and tobacco use, weight management, and diabetes control (if applicable). For nutritional guidance, patients will be counselled to avoid food that contain high saturated fat and cholesterol, such as processed meat, fired food, baked goods sweets etc. These counseling sessions of 45-50 minutes will be conducted on their scheduled appointment/follow-up at the hospital private rooms on their physical follow-ups post-discharge. Furthermore, a total of seven 5-10 minutes telephonic follow-up sessions will be conducted by the Researcher and a trained cardiac nurse within 12 weeks (weekly for the initial 3 weeks (2nd, 3rd, and 4th weeks), and then biweekly (5th, 7th, 9th, 11th weeks) until the 12th week).
Upon completion of phase 2 CR after the 12th week, they will be continuing the CR as phase 3. Phase 3 will be the long-term maintenance program that will include monthly phone calls for a total of seven 5-10 minutes telephonic follow-up sessions by the Researcher and a trained cardiac nurse up to 6 months from the date of discharge (16th , 20th, and 24th weeks). Patients will be encouraged to continue the personal health journal until 24 weeks of enrollment. The goal of HBCR is to support each patient to adopt a healthy lifestyle in a long run by putting each part of the intervention into their daily lives such as physical activity, healthy diet, etc.

Intervention code [1]

Rehabilitation

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

Patients in the Control Group will receive the usual care. The usual care for this study is defined as "following the cardiac procedure, patients get discharged and called for first follow-up 15 days after the procedure without any specific schedule. There is no cardiac rehabilitation facility available in the study setting. The routine care will be administered through face-to-face consultations physically during their scheduled follow-ups with cardiologists in the clinics for 15-20 minutes. Patients will be followed up to 6 months from the date of discharge from the hospital.

Control group

Active

Outcomes

Primary outcome [1]

Heart-Related Quality of Life using MacNew heart-related quality of life (HQRL) questionnaire

Timepoint [1]

Baseline (1-day following the procedure), 3month, and 6th months post-discharge.

Primary outcome [2]

Cardiac Anxiety using Cardiac Anxiety Questionnaire CAQ-18

Timepoint [2]

Baseline (1-day following the procedure), 3month, and 6th months post-discharge.

Primary outcome [3]

Cardiac Health Behaviors using Cardiac Behavior Scale - CHB-K21

Timepoint [3]

Baseline (1-day following the procedure), 3month, and 6th months post-discharge.

Secondary outcome [1]

“This is an additional primary outcome.”
Unplanned Emergency Visits
It will be measured by frequency of unplanned hospital visits. The data for unplanned hospital visits will be collected from participants through telephonic follow-up on 12th and 24th weeks.

Timepoint [1]

3month and 6th months post-discharge

Secondary outcome [2]

Systolic & Diastolic Blood Pressure (mmHg)

Blood pressure will be assessed on the physical follow-up in the clinic through mercury sphygmomanometer.

Timepoint [2]