First degree relatives of patients with premature coronary heart disease Circulatory System Chronic ischaemic heart disease, unspecified
Conditions
Interventions
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, w
Sponsors
University of Malta
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Malta
Outcome results
None listed