RecruitingACTRN12619001731189

Effectiveness of “Mobile health augmented Cardiac rehabilitation” (MCard) on health related quality of life, clinical and behavioral outcomes in post-acute coronary syndrome patients

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"


Sponsor

Aliya Hisam

Enrollment

160 participants

Start Date

Jul 1, 2019

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 35 YearssMax Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

After a heart attack (acute coronary syndrome, or ACS), patients need to make significant lifestyle changes — including healthier eating, more physical activity, and better medication adherence — to reduce the risk of another event. Cardiac rehabilitation programs are designed to support this, but many patients struggle to stay engaged. This study is testing a mobile health intervention called MCard, which delivers personalised health and lifestyle advice to patients via text messages sent through a specially designed software system. Participants who have had a documented heart attack will be randomly assigned to either receive the MCard text message program on top of their usual cardiac care, or continue with usual care alone. Researchers will measure quality of life, physical outcomes, and health behaviours over time. You may be eligible if you are aged 35 to 65, have had a documented heart attack, have an ejection fraction above 25%, and own a mobile phone (or have a caregiver who can assist). Pregnancy, serious concurrent illness, dialysis, or a previous stroke would make you ineligible.

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Interventions

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 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.


Locations(1)

Punjab, Pakistan

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ACTRN12619001731189


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