Secondary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health (S-PLAC 2)

Study Overview
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Brief Summary
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Prescribing lifestyle changes to patients who have cardiovascular disease (CVD) may be an extremely cost effective mechanism of improving health individually and for the NHS. Positive lifestyle changes such as improved diet, increased physical activity, quitting smoking and reducing alcohol consumption have been proven to reform the health status of individuals with CVD. S-PLAC 2 is a phase II study to determine the efficacy of a lifestyle prescription (L℞) in patients and healthcare practitioners in a secondary care setting (i.e. hospital clinics/wards).

Official Title
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Secondary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health (Phase II)

Conditions
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Cardiovascular Diseases, Cardiovascular Risk Factor, Health Behavior

Intervention / Treatment
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* Behavioral: Lifestyle Prescription (LRx)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and over Able and willing to provide written informed consent Understands written and spoken English Either an in/out- patient of Cardiology Exclusion Criteria: Participant is unwilling or unable to provide written informed consent Participant is pregnant Participant has a drug dependency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: The study is an interventional controlled observational study based in the Secondary care setting. Control groups will be utilized through the mechanism of wait-listing the enrolment of recruitment centres into the study. Mixed methods will be used for both data collection and analysis. Historical clinical participant data (pre-intervention) will be collected by the PI. data will be collected immediately after the consultation and at 3 months post intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control (Standard Care)<br>Standard care during consultations. Advice and guidance offered by clinicians verbally and sometimes the addition of leaflets or a referral. | |
| Experimental: Intervention (Standard Care plus Lifestyle prescription - LRx)<br>Standard care during consultations with the addition of a physical lifestyle prescription. Advice and guidance will be offered by clinicians verbally, whilst being supported with a lifestyle prescription and a possible referral if required. | Behavioral: Lifestyle Prescription (LRx)<br>* Standard care during consultations with the addition of a physical lifestyle prescription<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A prescription (LRx) being issued during a consultation | Number of so-signed prescription (LRx) forms. Total number of forms to be co-signed = 60 | During month 7 of the study | 
| Patient view of the prescription (LRx) and consultation Questionnaire | Completed study questionnaires. Total number of questionnaires to be completed = 120. Responses will be recorded to gain feedback from the patient participants regarding their thoughts and feelings of their consultation with and without the intervention of the prescription (LRx). Scale: 7 (minimum) to 41 (maximum). A lower value represents a better (more positive) outcome. | During month 7 of the study | 
| Healthcare practitioner (HCP) view of the prescription (LRx) and consultation questionnaire. | Completed clinician questionnaire. Total number of questionnaires to be completed = 6. Responses will be recorded to gain feedback from the clinicians regarding their thoughts and feelings of their consultations with and without the intervention of the prescription (LRx). Sections: Section 1 scale: 9 to 54 (a lower score represents a better, more positive outcome) Section 2 scale: 8 to 48 (a lower score represents a better, more positive outcome) Section 3 scale: 6 to 36 (a lower score represents a better, more positive outcome) Total score available: 23 to 138 | During month 7 of the study |