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

Not Applicable

Terminated

• Conditions: Health Behavior; Cardiovascular Diseases; Cardiovascular Risk Factor
• Interventions: Behavioral: Lifestyle Prescription (LRx)

• Registration Number: NCT04118673
• Lead Sponsor: University of South Wales

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-04
• Study Start: 2019-10-07
• Study First Posted: 2019-10-08
• Primary Completion: 2021-03-31
• Study Completion: 2023-03-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention (Standard Care plus Lifestyle prescription - LRx)	Lifestyle Prescription (LRx)	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.

Primary Outcome Measures

Name	Time	Method
A prescription (LRx) being issued during a consultation	During month 7 of the study	Number of so-signed prescription (LRx) forms. Total number of forms to be co-signed = 60
Patient view of the prescription (LRx) and consultation Questionnaire	During month 7 of the study	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.
Healthcare practitioner (HCP) view of the prescription (LRx) and consultation questionnaire.	During month 7 of the study	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

Trial Locations

Locations (1)

University of South Wales; 🇬🇧 Pontypridd, United Kingdom