Improving the lifestyle and heart health of siblings and offspring of patients who had a heart attack before the age of 55 in men or the age of 65 in women

• Register: ISRCTN
• Last refreshed on: 6 May 2024
• Main ID: ISRCTN21559170
• Date of registration: 06/08/2020
• Prospective Registration: Yes
• Primary sponsor: University of Malta
• Public title: Improving the lifestyle and heart health of siblings and offspring of patients who had a heart attack before the age of 55 in men or the age of 65 in women
• Scientific title: Feasibility and acceptability of a coronary risk reduction intervention for siblings and offspring of patients with premature coronary heart disease
• Date of first enrolment: 01/09/2020
• Target sample size: 100
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN21559170
• Study type: Interventional
• Study design: Randomised single-centre two-armed group randomized controlled trials with embedded interviews (Prevention)
• Phase: Not Applicable

Countries of recruitment

Malta

Contacts

• Name: Justin Lee Mifsud

Key inclusion & exclusion criteria

Inclusion criteria: 1. First-degree relatives of patients with premature CHD
2. Aged 30 years and older
3. Males and females
4. Maltese ethnicity
5. Seeking cardiovascular risk assessment
6. No history of cardiovascular disease
Exclusion criteria: 1. Participants must not have a history of rheumatoid arthritis and chronic kidney disease
2. Participants must not have contraindications against physical activities and are able to go up a flight of stairs comfortably
3. Participants must not be pregnant

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

First degree relatives of patients with premature coronary heart disease
Circulatory System
Chronic ischaemic heart disease, unspecified

Intervention(s)

Block randomization will be applied to balance out sample size between intervention group and control group. Block randomization of four rows of relatives, using an opaque sealed envelope technique, will be implemented for this study.

Intervention: Participants will have an initial face-to-face session (evaluation of modifiable risk factors, two-way risk factor communication, education and individualised counselling to set up a cardio-protective plan) followed by weekly telephone-based cardio-protective reinforcement sessions for up to 12 weeks.

Control: Participants will have limited intervention, consisting of one face to face session of lifestyle advice only.

Primary Outcome(s)

Feasibility measured using records of the number of:
1. Relatives recruited via patients - measured at recruitment stage
2. Relatives recruited via social media - measured at recruitment stage
3. Relatives recruited via poster method (local councils, pharmacies, social groups) - measured at recruitment stage
4. Relatives who expressed interest in the study - measured at recruitment stage
5. Relatives who are potentially eligible, with reasons for ineligibility - measured at recruitment stage
6. Relatives who agreed to participate in the trial - measured at recruitment stage
7. Relatives lost to follow-up (retention and drop-out rate) - measured at 12 months
8. Sessions delivered successfully - measured at 12 months

Furthermore, the feasibility of the intervention will include the time taken to:
1. Complete cardiovascular risk assessment - measured at baseline, 6 months and 12 months.
2. Deliver the intervention (in-person session and telephone sessions) - time recorded for the individualized intervention session (in-person session and telephone sessions)

Acceptability will be evaluated by determining how well the intervention is received by first degree relatives and the extent to which this intervention could meet the needs of first-degree relatives. This requires data of the participants’ most valued intervention components in terms of being supportive and the participants' views of the quality of interactions during intervention sessions, along with how well the intervention targets can be incorporated into participants' personal lifestyles, taking into consideration any difficulties that were experienced while attempting to comply with the programme goals. To collect this data, post-intervention questionnaires and interviews will be used. This data will determine which part of the intervention the participants found most supportive and which parts may require further refinement. Evaluated at 12 months.

Secondary Outcome(s)

1. Smoking status measured using a CO monitor at baseline, 6 months and 12 months.
2. Dietary status measured using the Mediterranean diet score at baseline, 6 months and 12 months
3. Physical activity status measured using the RAPA score at baseline, 6 months and 12 months
4. Blood biochemicals (lipids, HbA1c) measured using the Roche COBAS analyser, at baseline, 6 months and 12 months
5. Resting physiological measurements measured using an Omron blood pressure monitor, measured two to three times by auscultation, and an average will be taken as the final measurement, and heart rate measured manually by radial pulse at baseline, 6 months and 12 months
6. Anthropometric measures (BMI, waist circumference) measured at baseline, 6 months and 12 months
7. Heart age score measured using the Heart Age calculator at baseline, 6 months and 12 months
8. Health literacy measured using the Health Literacy Score at baseline, 6 months and 12 months

Secondary ID(s)

HEC03 CT01/20

Nil known

Source(s) of Monetary Support

University of Malta

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; 1. Approved 04/08/2020, University of Malta Research Ethics Committee (University of Malta, Msida MSD 2080; [phone]; [e-mail]), ref: UNIQUE FORM ID: 3756_191119 2. Approved 04/08/2020, Health Ethics Committee Malta (Health Ethics Committee, Directorate for Health Information & Research 95, Gwardamangia Hill, Pieta' - Malta PTA 1313 address; [phone]; [e-mail]), ref: HEC03 CT01/20

Results

• Results available: Yes
• Date Completed: 20/09/2022