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Trial registered on ANZCTR


Registration number
ACTRN12619001731189
Ethics application status
Approved
Date submitted
7/10/2019
Date registered
9/12/2019
Date last updated
9/12/2019
Date data sharing statement initially provided
9/12/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of “Mobile health augmented Cardiac rehabilitation” (MCard) on health related quality of life, clinical and behavioral outcomes in post-acute coronary syndrome patients
Scientific title
To determine the effectiveness of “Mobile health augmented Cardiac rehabilitation” (MCard) on health related quality of life, clinical and behavioral outcomes in post-acute coronary syndrome patients"
Secondary ID [1] 299964 0
Nil
Universal Trial Number (UTN)
U1111-1215-1337
Trial acronym
MCard
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post acute coronary syndrome 308143 0
Mobile Health Augmented Cardiac Rehabilitation 308144 0
Health Related Quality of Life 314545 0
Major Adverse Cardiac Events 314547 0
Condition category
Condition code
Public Health 307178 307178 0 0
Health service research
Physical Medicine / Rehabilitation 307179 307179 0 0
Other physical medicine / rehabilitation
Cardiovascular 312892 312892 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The cardiac rehabilitation (CR) intervention components are describes in accordance with Template for Intervention Description and Replication (TIDieR) as follows:
The intervention group will receive the following CR component relatiev to each other:
Component No: 1 Behavior change counselling : (First phase within hospital stay)
Rationale/goals Patient will be more inquisitive and anxious regarding the factors that lead to this health event. They would be more receptive regarding the life style changes that could prevent further deterioration in their health.
Materials provided to participants and used in the component were specifically designed for this trial and testing and then edited accordingly. Pamphlets related to harmful effect of smoking, sedentary lifestyle, unhealthy diet and alcohol abstinence. Also importance of self-monitoring, medicine compliance, salt restriction and regular follow-up will be provided through brochure.
Conducted by/experience Principal Investigator/research associate at least 2 years’ experience
Mode of delivery Face to face interview
Location Hospital premises
No. of times per week/ Duration of session One time after enrollment / 30-45 minutes session

Component No: 2
Healthy diet counselling: (First phase within hospital stay)
Rationale/goals Healthy diet choices will be encouraged and unhealthy discouraged. Healthy start will also lead to good bowel habits as well.
Materials provided to participants and used in the component Healthy and unhealthy food choices information through a chart will be provided based on WHO healthy diet guidelines.
Conducted by/experience Dietician having at least 2 years’ experience
Mode of delivery Face to face interview
Location Hospital premises
No. of times per week/ Duration of session One session /15-30 minutes session

Component No: 3 Physical activity counselling :
(First phase within hospital stay)
Rationale/goals Early mobilization with slow and gradual increase in walk will help participant build confidence and reduce stress related to the health event. Also help in improving physiological parameters blood pressure, weight etc.
Materials provided to participants and used in the component A sheet for recording details regarding daily steps (pedometer reading) along with physical activity (if any) for a duration of 3 months.
Conducted by/experience Physiotherapist at least 2 years’ experience
Mode of delivery Face to face interview
Location Hospital premises
No. of times per week/ Duration of session One session / gradually starting from 3 -5 minutes
Component No: 4
Counselling regarding self-monitoring plus empowering with self-monitoring devices: (Phase 1: within hospital stay and self-monitoring continued at home)
Rationale/goals Participants will be more enthusiastic to learn about how to take care of themselves as follows:
1. Blood pressure and weight monitoring weekly
2. Steps monitoring (through Pedometer) daily.
Participant will be empowered with self-assessment tools (Digital blood pressure apparatus, digital weight machine and pedometer) so that they can take care of themselves.
Self-monitoring will be emphasized.
Materials provided to all the participants and used in the component are Digital Blood pressure apparatus + weight machine + pedometer.
Also pamphlet for entering data of blood pressure, weight and steps taken will be provided for 6 months duration: starting entries while in hospital
Conducted by/experience Principal Investigator or research associate/ at least 2 years’ experience
Mode of delivery Face to face interview
Location Hospital premises
No. of times per week/ Duration of session Once during hospital / 15-30 minutes session

Component No: 5
Health information transfer through mobile text communication: (Phase 2: After hospital discharge)
Sample Health Messages
Hi (Name),
1. Physical Activity
• Insufficient physical activity is a key risk factor for non-communicable diseases (NCDs) such as cardiovascular diseases and diabetes
• Inactive people should start with lower levels of physical activity, as part of their daily routine, and gradually increase duration, frequency, and intensity over time after his doctor consultation.
• Start walk with 3-5 minutes at a time after consulting cardiologist and gradually build up your walk stamina
• Physical activity overall improves health and heart functions

2. Healthy Diet
• An unhealthy diet is one of the major risk factors for cardiovascular diseases
• Eat more fruit, vegetables, legumes, nuts and grains more often
• Reduce intake of salt, sugar and fats
• In your diet include lean meats, poultry, fish, beans and eggs
• Take diet that is low in fats/cholesterol, salt, and sugars
• Use more vegetables and fruit in your daily diet.
• Avoid fried/junk food as much as possible
• Avoid fizzy/carbonated drinks

3. Salt restriction
• High salt increases your blood pressure
• High salt intake increases chances of high blood pressure and heart problems
• Limit your salt intake to less than a tea spoon (3 gram) in all food per day
4. Tobacco Cessation
• Tobacco causes heart diseases and lung caner
• If you quit tobacco/smoking, it clearly decreases chances of heart attack and lung cancer.
• Quitting all forms of tobacco also saves you money and protects your family and friends from diseases related to second-hand smoke.
• Those who continue to use tobacco after heart attack are 6 times more at risk of heart attack.

5. Medicine compliance
• Take medicines according to doctor prescription
• Do not change your medicine or their doses without your doctor consultation.

6. Self-Monitoring
• Check your blood pressure at least once weekly
• Kindly check your body weight at least once weekly
• Kindly check your steps taken per day

Rationale/goals Participants at this stage needs reinforcing of all the modifiable risk factors, self –monitoring. They need to monitor their blood pressure, weight and physical activity along with encouragement to do so. They will be provided with a helpline number in case they have queries related to preventive aspect of their health.
Materials provided to participants and used in the component Self-monitoring devices, leaflets with information related to above 4 components in line with WHO Guidelines.
A helpline number will be provided to them in case they have any queries related to preventive aspect of the disease or information provided.
Procedure/Activities/Process Text messages communicated at least once daily till 24 weeks (in Urdu and/or English language based on their preferences.

Conducted by/experience Principal investigator /at least 5 years’ experience
Mode of delivery Text messages via mobile communication
Location At hospital and patients own premises
No. of times per week/ Duration of session Once daily on 6 working days i.e. behavior change, self-monitoring importance, healthy diet options and benefits, physical activity, medicine compliance and follow-up importance and smoking cessation. A total of at least 6 messages per week will be communicated to each participant of the intervention group after they are discharged from hospital.
Adherence Adherence to the self-monitoring will be examined at the end of 12 weeks and 24 weeks by examining the data entry sheet provided back by the participant or telephonic confirmation of entry from the participant. If at least 50% of the intervention group have entered their blood pressure, number of steps taken daily and weight at least once weekly, then adherence of the cardiac rehabilitation will be sufficient.



Intervention code [1] 301414 0
Rehabilitation
Intervention code [2] 301415 0
Prevention
Intervention code [3] 301416 0
Lifestyle
Comparator / control treatment
Post-acute coronary participants to whom usual care is given/Active control
Usual care was the treatment given to the patient as per their protocol advised by the treating cardiologist. The routine emergency care was given to patients along with counselling them on how to take care of themselves along with counseling them how to use the self monitoring devices and asked them to make entries in the pamphlet accordingly.
The mobile text messages were not communicated to them.
Control group
Active

Outcomes
Primary outcome [1] 306133 0
Health related quality of life measured through generic tool that is Short form 12
This is a composite primary tool which has 12 items and gives a score from 0 to 100.
zero being the poorest quality of life while 100 being the excellent quality of life
Timepoint [1] 306133 0
At baseline, 12 weeks and then 24 weeks after enrollment.
Primary outcome [2] 322140 0
Health related quality of life measured through specific tool that is MacNew QLMI
(MacNew Quality of life after myocardial infarction)
This is a composite primary tool which has 26 items and gives a score from 1 to 7.
One being the poorest quality of life while 7 being the excellent quality of life
Timepoint [2] 322140 0
At baseline, at 12 weeks and at 24 weeks after enrollment
Secondary outcome [1] 347671 0
Systolic Blood pressure measured by self through digital blood pressure apparatus.

Timepoint [1] 347671 0
at baseline, 12 weeks and then 24 weeks
Secondary outcome [2] 347672 0
Diastolic Blood pressure monitoring by self assessment through digital blood pressure apparatus
Timepoint [2] 347672 0
At baseline, 12 weeks and 24 weeks
Secondary outcome [3] 377453 0
Body weight monitoring by one-self through digital weight machine
Timepoint [3] 377453 0
At baseline, 12 weeks and 24 weeks after enrollment
Secondary outcome [4] 377454 0
Regarding subjective medicine compliance , in face-to- interview ( or telephonic interview), the participant will be asked following question:
Do you take medicine according to your physician/cardiologist recommendations?
a) Yes
b) No
c) Don't know
Timepoint [4] 377454 0
At baseline, 12 weeks and 24 weeks after enrollment
Secondary outcome [5] 377458 0
Regarding subjective salt restriction, in face-to- interview ( or telephonic interview), the participant will be asked following question:
Have you reduced your salt intake to less than one teaspoon per day?
a) Yes
b) No
c) Don't know
Timepoint [5] 377458 0
At baseline, 12 weeks and 24 weeks after enrollment
Secondary outcome [6] 377459 0
Regarding subjective smoking cessation, in face-to- interview ( or telephonic interview), the participant will be asked following question:
Have you reduced no of cigarettes per day?
a) Yes
b) No
c) Don't know
Timepoint [6] 377459 0
At baseline, 12 weeks and 24 weeks after enrollment
Secondary outcome [7] 377463 0
Regarding number of current days of admissions, in face-to- interview ( or telephonic interview), the participant will be asked following question:
For how many days you were admitted in hospital for current acute coronary syndrome management?
----------------days
Timepoint [7] 377463 0
At baseline, 12 weeks and 24 weeks after enrollment
Secondary outcome [8] 377464 0
Regarding major adverse cardiac events (MACE), in face-to- interview ( or telephonic interview), the participant or their attendant will be asked following question:
It is a composite secondary outcome which will be present if any one of the following is reported:
Have you been diagnosed or experienced any one of the following in the past 12 weeks?
1. Re-infarction : a) Yes b) No c) Know don't
2, Symptom driven re-vascularization a) Yes b) No c) Know don't
3. Heart failure a) Yes b) No c) Know don't
4. Death a) Yes b) No c) Know don't
If any one of the above is stated YES, then MACE will be present
If none of the above is present, then MACE will be absent
Timepoint [8] 377464 0
At 12 weeks and 24 weeks after enrollment
Secondary outcome [9] 377465 0
Regarding subjective preference for healthy food intake, in face-to- interview ( or telephonic interview), the participant will be asked following question:
In your diet, d you prefer to eat more vegetables and fruits as compared to before acute coronary syndrome?
a) Yes
b) No
c) Don't know
Timepoint [9] 377465 0
At baseline, 12 weeks and 24 weeks after enrollment
Secondary outcome [10] 377466 0
Mobile health augmented cardiac rehabilitation acceptability measured on likert scale from 1 to 5
1: unacceptable
2: slightly acceptable
3: neutral
4: slightly acceptable
5: acceptable
Timepoint [10] 377466 0
At 24 week after enrollment
Secondary outcome [11] 377565 0
Regarding subjective physical activity, in face-to- interview ( or telephonic interview), the participant will be asked following question:
Do you walk at-least 20 min thrice per week?
a) Yes
b) No
c) Don't know
Timepoint [11] 377565 0
At baseline, 12 weeks and 24 weeks after enrollment

Eligibility
Key inclusion criteria
Age eligibility: 35 till 65 years
Both Gender
Documented ACS evidence in the past
Ejection fraction of > 25
Mobile phone ownership or a caretaker who can assist in handling mobile
Informed voluntary written consent
May have undergone cardiac revascularization procedure or Thrombolytic therapy
Minimum age
35 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients having any one of the following will be excluded
Not physically or mentally capable of handling mobile phone
Familial hypercholesterolemia
Cerebrovascular accident
Hemodialysis or peritoneal dialysis
Hepatitis B or C
Serious concurrent disease, such as malignancy
Is or may be pregnant

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome measure that is HRQoL physical component summary was used for sample size estimation in STATA version 14. A sample size of 61 per group in ratio of 1:1 was calculated by two independent mean test (control group; 39.09 and intervention group 42.65), assuming a variability of 6.74 and 7.14 in control and intervention group respectively , a power of 80% and a significance level of 5%. To allow for a predicted 25% drop-out or lost to follow-up rate from adverse events, the sample size has been increased to 80 per group, recruiting 160 participants in each arm (80 x 2=160)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/07/2019
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
160
Accrual to date
40
Final
Recruitment outside Australia
Country [1] 21904 0
Pakistan
State/province [1] 21904 0
Punjab

Funding & Sponsors
Funding source category [1] 299664 0
University
Name [1] 299664 0
Khyber Medical University
Country [1] 299664 0
Pakistan
Funding source category [2] 303979 0
Self funded/Unfunded
Name [2] 303979 0
Aliya Hisam
Country [2] 303979 0
Pakistan
Primary sponsor type
Individual
Name
Aliya Hisam
Address
Associate Professor
Community Medicine Dept.
Army Medical College (AMC),
Abid Majeed Road,
Rawalpindi, Punjab Province,
Postal code: 46000
Pakistan
Country
Pakistan
Secondary sponsor category [1] 304151 0
None
Name [1] 304151 0
Address [1] 304151 0
Country [1] 304151 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300561 0
Khyber Medical University Ethics Board
Ethics committee address [1] 300561 0
Ethics committee country [1] 300561 0
Pakistan
Date submitted for ethics approval [1] 300561 0
10/04/2018
Approval date [1] 300561 0
19/11/2018
Ethics approval number [1] 300561 0
DIR/KMU-EB/MH/000486
Ethics committee name [2] 304478 0
Armed Forces Institute of Cardiology and National Institute of Heart Diseases Rawalpindi
Ethics committee address [2] 304478 0
Ethics committee country [2] 304478 0
Pakistan
Date submitted for ethics approval [2] 304478 0
30/11/2017
Approval date [2] 304478 0
16/05/2018
Ethics approval number [2] 304478 0
AFIC-IERB-SOP-15

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

Contacts
Principal investigator
Name 84070 0
A/Prof Aliya Hisam
Address 84070 0
Associate Professor,
Community Medicine Department,
Army Medical College (AMC),
National University of Medical Sciences (NUMS),
Abid Majeed Road, Punjab Province
Postal Code: 25000
Rawalpindi, Pakistan
Country 84070 0
Pakistan
Phone 84070 0
+92 321 5111811
Fax 84070 0
Email 84070 0
aaleya@yahoo.com
Contact person for public queries
Name 84071 0
Aliya Hisam
Address 84071 0
Associate Professor,
Community Medicine Department,
Army Medical College (AMC),
National University of Medical Sciences (NUMS),
Abid Majeed Road, Punjab Province
Postal Code: 25000
Rawalpindi, Pakistan
Country 84071 0
Pakistan
Phone 84071 0
+92 321 5111811
Fax 84071 0
Email 84071 0
aaleya@yahoo.com
Contact person for scientific queries
Name 84072 0
Aliya Hisam
Address 84072 0
Associate Professor,
Community Medicine Department,
Army Medical College (AMC),
National University of Medical Sciences (NUMS),
Abid Majeed Road, Punjab Province
Postal Code: 25000
Rawalpindi, Pakistan
Country 84072 0
Pakistan
Phone 84072 0
+92 321 5111811
Fax 84072 0
Email 84072 0
aaleya@yahoo.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To maintain participants confidentiality, their individual data will not be shared publicly but if required by some agency or organization, data can be shared on request but anonymity of the participant will be maintained.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5247Ethical approval    375253-(Uploaded-07-10-2019-19-38-48)-Study-related document.pdf
5248Ethical approval  aaleya@yahoo.com 375253-(Uploaded-07-10-2019-19-39-31)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of mobile health augmented cardiac rehabilitation on behavioural outcomes among post-acute coronary syndrome patients: A randomised controlled trial.2021https://dx.doi.org/10.29271/jcpsp.2021.10.1148
EmbaseMobile health augmented cardiac rehabilitation (MCard) in post-acute coronary syndrome patients: A randomised controlled trial protocol.2021https://dx.doi.org/10.12669/pjms.37.3.3664
EmbaseEffectiveness of Mobile Health Augmented Cardiac Rehabilitation (MCard) on health-related quality of life among post-acute coronary syndrome patients: A randomized controlled trial.2022https://dx.doi.org/10.12669/pjms.38.3.4724
N.B. These documents automatically identified may not have been verified by the study sponsor.