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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
20/12/2024
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] 308537 0
‘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 328378 0
Heart Related Anxiety 328379 0
Hypertension 328382 0
Diabetes Mellitus 328645 0
Obesity 328646 0
Condition category
Condition code
Cardiovascular 325410 325410 0 0
Coronary heart disease
Physical Medicine / Rehabilitation 325411 325411 0 0
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] 324980 0
Rehabilitation
Intervention code [2] 324981 0
Lifestyle
Intervention code [3] 324982 0
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. Patients were provided with the educational booklet at the time of discharge without any further instructions or counseling.
Control group
Active

Outcomes
Primary outcome [1] 333267 0
Heart-Related Quality of Life using MacNew heart-related quality of life (HQRL) questionnaire
Timepoint [1] 333267 0
Baseline (1-day following the procedure), 3month, and 6th months post-discharge.
Primary outcome [2] 333269 0
Cardiac Anxiety using Cardiac Anxiety Questionnaire CAQ-18
Timepoint [2] 333269 0
Baseline (1-day following the procedure), 3month, and 6th months post-discharge.
Primary outcome [3] 333270 0
Cardiac Health Behaviors using Cardiac Behavior Scale - CHB-K21
Timepoint [3] 333270 0
Baseline (1-day following the procedure), 3month, and 6th months post-discharge.
Secondary outcome [1] 416420 0
“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] 416420 0
3month and 6th months post-discharge
Secondary outcome [2] 417082 0
Systolic & Diastolic Blood Pressure (mmHg)

Blood pressure will be assessed on the physical follow-up in the clinic through mercury sphygmomanometer.
Timepoint [2] 417082 0
Baseline (1-day following the procedure), 12th week, and 24th weeks post-discharge.
Secondary outcome [3] 417083 0
Heart Rate beats/min,

It will be assessed on the physical follow-up in the clinic through manual/per minute count.
Timepoint [3] 417083 0
Baseline (1-day following the procedure), 12th week, and 24th weeks post-discharge.
Secondary outcome [4] 417084 0
Blood Glucose mg/dl


It will be assessed on the physical follow-up in the clinic through a reliable glucometer and strip.
Timepoint [4] 417084 0
Baseline (1-day following the procedure), 12th week, and 24th weeks post-discharge.
Secondary outcome [5] 417085 0
Weight (kg), Height (cm),

It will be assessed on the physical follow-up in the clinic through a reliable weight and height scale (ZT-160).
Timepoint [5] 417085 0
Baseline (1-day following the procedure), 12th week, and 24th weeks post-discharge.
Secondary outcome [6] 417086 0
Hemoglobin mg/dl,

It will be recorded from patients' medical records of the lab done in hospital's laboratory setting.
Timepoint [6] 417086 0
Baseline Only
Secondary outcome [7] 417087 0
Triglycerides mg/dl, LDL-C mg/dl, HDL-C mg/dl.

It will be recorded from patients' medical records of the lab done in hospital's laboratory setting.
Timepoint [7] 417087 0
Baseline Only

Eligibility
Key inclusion criteria
Patients with age between 18 and 65 years.
Male and female.
Patients diagnosed with acute ST elevated MI (STEMI), non-ST elevated MI (NSTEMI) and/or unstable angina.
Patients underwent first percutaneous coronary intervention (PCI) and/or managed medically.
Patients with New York Heart Association (NYHA) classification for dyspnoea I and II.
Patients residing within 50 km of the vicinity of the Mayo Hospital Lahore.
Patients who can understand, read, and speak Urdu.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with left ventricular ejection fraction <35%.
Patients with resting systolic BP>200 mm Hg or resting diastolic BP>110 mm Hg.
Patients with signs and symptoms of postprocedure ischaemia.
All those patients who have been prescribed restricted mobility due to comorbidities such as aortic stenosis and dysrhythmias.
All those patients who have altered quality of life such as due to comorbidities end-stage renal disease, liver failure and respiratory failure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A written informed consent will be obtained from the study subjects after screening; they will be informed about the study purposes, objectives, potential risks and benefits, data collection procedure, and outcome of the study. After obtaining the informed consent, the subjects will be assessed based on the eligibility criteria by the researcher and will be referred an allocator who will have the sealed opaque envelopes containing codes for both the groups. The allocator will be blinded for the codes and its meaning. Envelops will be mixed well to ensure the prevention of the selection bias. The allocator will open the envelop for subjects and assign them codes. The patients will be randomly allocated to either Conventional or Interventional groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sealed Opaque Envelopes Containing 4 different codes 2 out of 4 codes will be pointing either intervention or control groups. The meaning of codes will be blinded to independent allocator and the research team will have access to code meanings only.

The subjects will be assessed based on the eligibility criteria by the researcher and will be referred to an independent allocator who will have the sealed opaque envelopes containing 4 different codes for both groups. The allocator will be blinded to the codes and their meanings. Envelops will be mixed well to ensure the prevention of selection bias. The allocator will open envelop for each subject and assign them codes. The patients will be randomly allocated to either Conventional or Interventional groups. The allocator will share the list of patients contain their names, assign codes, and contact number with the researcher. The researcher then divides the patients based on the coding system he developed to allocate study subjects in both groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
sample size is calculated using formula a randomized controlled trial with continuous outcome using following parameters:
Mean in a treatment group = 80.80, SD. in a treatment group = 13.70 (Wang & Ji, 2020)
Mean in a control group = 73.20, SD. in a control group = 13.00 (Wang & Ji, 2020)
Ratio (control/treatment) = 1.00
Alpha (a) = 0.05, Z (0.975) = 1.959964
Beta (ß) = 0.20, Z (0.800) = 0.841621
Calculated Sample size: Treatments = 49, Controls = 49
(Bernard, 2000; Ngamjarus & Chongsuvivatwong, 2014)
The calculated sample size is 49 for each group. After adding 20% dropout rate, the final sample size is 59 participants in each group. So, the total sample size for two groups will be 118, collectively.

Data Analysis Plan
Data will be entered and analyzed through SPSS version 24.0. After ensuring the normality, the data will be analyzed through descriptive (mean, median, mode) and inferential statistics such as dependent T-Test/Wilcoxon Sign Rank, Independent T-Test/Mann Whitney U, and Repeated measures ANOVA/Friedman to see the difference within the groups, between groups, and between three intervals, respectively.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2023
Actual
27/02/2024
Date of last participant enrolment
Anticipated
1/06/2023
Actual
24/05/2024
Date of last data collection
Anticipated
31/10/2024
Actual
29/10/2024
Sample size
Target
118
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 25163 0
Pakistan
State/province [1] 25163 0
Punjab

Funding & Sponsors
Funding source category [1] 312784 0
Government body
Name [1] 312784 0
National Institute for Health and Care Research (NIHR)
Country [1] 312784 0
United Kingdom
Primary sponsor type
University
Name
NIHR
Address
Aga Khan University Hospital, Karachi Stadium Road, P.O. Box 3500 Karachi, 74800, Pakistan
Country
United Kingdom
Secondary sponsor category [1] 314567 0
None
Name [1] 314567 0
none
Address [1] 314567 0
none
Country [1] 314567 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312075 0
Aga Khan University Ethics Research Committee (AKU-ERC)
Ethics committee address [1] 312075 0
Ethics committee country [1] 312075 0
Pakistan
Date submitted for ethics approval [1] 312075 0
05/12/2022
Approval date [1] 312075 0
02/03/2023
Ethics approval number [1] 312075 0
2023-8282-24191

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123378 0
Dr Rubina Barolia
Address 123378 0
Aga Khan University Hospital, Karachi Stadium Road, P.O. Box 3500. Karachi, 74800, Pakistan.
Country 123378 0
Pakistan
Phone 123378 0
+92 21 34865446
Fax 123378 0
Email 123378 0
rubina.barolia@aku.edu
Contact person for public queries
Name 123379 0
Adnan Yaqoob
Address 123379 0
Aga Khan University Hospital, Karachi Stadium Road, P.O. Box 3500. Karachi, 74800, Pakistan.
Country 123379 0
Pakistan
Phone 123379 0
+923135522694
Fax 123379 0
Email 123379 0
adnan.yaqoob@scholar.aku.edu
Contact person for scientific queries
Name 123380 0
Rubina Barolia
Address 123380 0
Aga Khan University Hospital, Karachi Stadium Road, P.O. Box 3500. Karachi, 74800, Pakistan.
Country 123380 0
Pakistan
Phone 123380 0
+92 21 34865446
Fax 123380 0
Email 123380 0
rubina.barolia@aku.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Results will be published in an open access journal after completion of this trial.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17769Study protocolYaqoob, A., Barolia, R., Ladak, L., Hanif, A., Khan, A. H., & Sahar, W. (2023). Home-based cardiac rehabilitation: Development, implementation and outcome evaluation in patients with coronary artery diseases in Lahore, Pakistan – a mixed-methods study protocol. BMJ Open, 13(6), e073673. https://doi.org/10.1136/bmjopen-2023-073673https://bmjopen.bmj.com/content/13/6/e073673adnan.yaqoob@scholar.aku.edu



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHome-based cardiac rehabilitation: Development, implementation and outcome evaluation in patients with coronary artery diseases in Lahore, Pakistan - A mixed-methods study protocol.2023https://dx.doi.org/10.1136/bmjopen-2023-073673
N.B. These documents automatically identified may not have been verified by the study sponsor.