ANZCTR - Registration

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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]

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

Mobile Health Augmented Cardiac Rehabilitation

Health Related Quality of Life

Major Adverse Cardiac Events

Condition category

Condition code

Public Health

Health service research

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Cardiovascular

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]

Rehabilitation

Intervention code [2]

Prevention

Intervention code [3]

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]

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]

At baseline, 12 weeks and then 24 weeks after enrollment.

Primary outcome [2]

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]

At baseline, at 12 weeks and at 24 weeks after enrollment

Secondary outcome [1]

Systolic Blood pressure measured by self through digital blood pressure apparatus.

Timepoint [1]

at baseline, 12 weeks and then 24 weeks

Secondary outcome [2]

Diastolic Blood pressure monitoring by self assessment through digital blood pressure apparatus

Timepoint [2]

At baseline, 12 weeks and 24 weeks

Secondary outcome [3]

Body weight monitoring by one-self through digital weight machine

Timepoint [3]

At baseline, 12 weeks and 24 weeks after enrollment

Secondary outcome [4]

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]

At baseline, 12 weeks and 24 weeks after enrollment

Secondary outcome [5]

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]

At baseline, 12 weeks and 24 weeks after enrollment

Secondary outcome [6]

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]

At baseline, 12 weeks and 24 weeks after enrollment

Secondary outcome [7]

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]

At baseline, 12 weeks and 24 weeks after enrollment

Secondary outcome [8]

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]

At 12 weeks and 24 weeks after enrollment

Secondary outcome [9]

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]

At baseline, 12 weeks and 24 weeks after enrollment

Secondary outcome [10]

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]

At 24 week after enrollment

Secondary outcome [11]

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]

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?

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

Final

Recruitment outside Australia

Country [1]

Pakistan

State/province [1]

Punjab

Funding & Sponsors

Funding source category [1]

University

Name [1]

Khyber Medical University

Address [1]

Institute of Public Health and Social Sciences (IPH&SS)
Khyber Medical University (KMU)
Phase V, Main Hayatabad road, Peshawar,
Khyber Pakhtunkhwa,
Pakistan

Country [1]

Pakistan

Funding source category [2]

Self funded/Unfunded

Name [2]

Aliya Hisam

Address [2]

Associate Professor
Community Medicine Dept.
Army Medical College (AMC),
Abid Majeed Road,
Rawalpindi, Punjab Province,
Postal code: 46000
Pakistan

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Khyber Medical University Ethics Board

Ethics committee address [1]

Institute of Public Health & Social Sciences (IPH&SS)
Khyber Medical University (KMU)
Phase V, Main Hayatabad road, Peshawar
Khyber Pakhtunkhwa Province,
Postal Code:25000
Pakistan

Ethics committee country [1]

Pakistan

Date submitted for ethics approval [1]

10/04/2018

Approval date [1]

19/11/2018

Ethics approval number [1]

DIR/KMU-EB/MH/000486

Ethics committee name [2]

Armed Forces Institute of Cardiology and National Institute of Heart Diseases Rawalpindi

Ethics committee address [2]

Armed Forces Institute of Cardiology and National Institute of Heart Diseases Rawalpindi
Military Hospital Road, Mall road
Rawalpindi, Punjab Province
Postal code: 46000
Rawalpindi, Pakistan

Ethics committee country [2]

Pakistan

Date submitted for ethics approval [2]

30/11/2017

Approval date [2]

16/05/2018

Ethics approval number [2]

AFIC-IERB-SOP-15

Summary

Brief summary

Assess the impact of a cardiac rehabilitation program in which text messages to post-acute coronary syndrome patients related to healthy life style modification will be communicated through a specifically designed software.
We hypothesized that post-ACS patients who receive the interventions will have positive impact on their health outcomes (HRQoL, clinical and behavioral) as compared to those who receive the usual care.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Aliya Hisam

Address

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

Pakistan

Phone

+92 321 5111811

Fax

[email protected]

Contact person for public queries

Name

A/Prof Aliya Hisam

Address

Country

Pakistan

Phone

+92 321 5111811

Fax

[email protected]

Contact person for scientific queries

Name

A/Prof Aliya Hisam

Address

Country

Pakistan

Phone

+92 321 5111811

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
5247	Ethical approval					375253-(Uploaded-07-10-2019-19-38-48)-Study-related document.pdf
5248	Ethical approval			[email protected]		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

Source	Title	Year of Publication	DOI
Embase	Mobile health augmented cardiac rehabilitation (MCard) in post-acute coronary syndrome patients: A randomised controlled trial protocol.	2021	https://dx.doi.org/10.12669/pjms.37.3.3664
Embase	Effectiveness of mobile health augmented cardiac rehabilitation on behavioural outcomes among post-acute coronary syndrome patients: A randomised controlled trial.	2021	https://dx.doi.org/10.29271/jcpsp.2021.10.1148
Embase	Effectiveness of Mobile Health Augmented Cardiac Rehabilitation (MCard) on health-related quality of life among post-acute coronary syndrome patients: A randomized controlled trial.	2022	https://dx.doi.org/10.12669/pjms.38.3.4724

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically