An educational intervention to promote health-related quality of life after an acute coronary syndrome

The effectiveness of an educational intervention using Social Cognitive Theory versus standard care initiated during hospitalization at a coronary unit, in promoting health-related quality of life of adult and elderly patients with acute coronary syndrome: A feasibility randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13355076

Enrollment

120

Registered

2018-08-08

Start date

2018-09-15

Completion date

Unknown

Last updated

2019-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute coronary syndrome Circulatory System Acute ischaemic heart disease

Interventions

Participants will be randomised into either the intervention or the control group using web-based block randomisation (20 blocks of 6 participants). At the baseline, participants in bo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 21 years or old 2. Hospitalised due to acute coronary syndrome 3. Able to read and write in Portuguese 4. No diagnosed cognitive condition 5. Able to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Submitted for cardiac surgery and/or with other major comorbidities 2. Haemodynamic instability

Design outcomes

Primary

Measure	Time frame
The following will be assessed before (baseline), 1 month and 3 months after the educational intervention: 1. Health-related quality of life, assessed using the EQ-5D and MacNew Quality of Life Questionnaire 2. Demographic and clinical data: 2.1. Demographic data assessed using a questionnaire including age, gender, ethnicity, level of education, marital status, professional activity, family household, daily physical activity and smoking habits 2.2. Clinical data, assessed by the health professional during data collection or from patients' medical records, based on the European Guidelines on cardiovascular disease prevention in clinical practice. This data includes weight, BMI, abdominal perimeter, blood pressure, cholesterol, LDLs and blood glucose levels. Questions about this will also be included in the questionnaire for participant information.	—

Measure

Time frame

The following will be assessed before (baseline), 1 month and 3 months after the educational intervention: 1. Health-related quality of life, assessed using the EQ-5D and MacNew Quality of Life Questionnaire 2. Demographic and clinical data: 2.1. Demographic data assessed using a questionnaire including age, gender, ethnicity, level of education, marital status, professional activity, family household, daily physical activity and smoking habits 2.2. Clinical data, assessed by the health professional during data collection or from patients' medical records, based on the European Guidelines on cardiovascular disease prevention in clinical practice. This data includes weight, BMI, abdominal perimeter, blood pressure, cholesterol, LDLs and blood glucose levels. Questions about this will also be included in the questionnaire for participant information.

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Secondary

Measure	Time frame
The following are assessed through statistical analysis of data from the demographic and clinical questionnaires at the baseline and after 3 months: 1. Body weight 2. Blood pressure 3. Lipid profile management 4. Lifestyle - changes in the following: 4.1. Nutrition 4.2. Smoking 4.3. Physical activity The following are assessed using data from the calendar completed by the participants over the 3 month study period: 5. Adherence to therapy 6. Number of re-hospitalisations	—

Measure

Time frame

The following are assessed through statistical analysis of data from the demographic and clinical questionnaires at the baseline and after 3 months: 1. Body weight 2. Blood pressure 3. Lipid profile management 4. Lifestyle - changes in the following: 4.1. Nutrition 4.2. Smoking 4.3. Physical activity The following are assessed using data from the calendar completed by the participants over the 3 month study period: 5. Adherence to therapy 6. Number of re-hospitalisations

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Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026