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

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

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).

Study Overview

• Status: Terminated
• Conditions: Cardiovascular Diseases; Health Behavior; Cardiovascular Risk Factor
• Intervention / Treatment: Behavioral: Lifestyle Prescription (LRx)

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Pontypridd, United Kingdom
    • University of South Wales

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control (Standard Care); 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); 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); Standard care during consultations with the addition of a physical lifestyle prescription

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of South Wales
• Collaborators: Public Health Wales; Cwm Taf University Health Board

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 4, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 260481

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No