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

NCT04118673 | Terminated

• 1 other identifier: 260481
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiovascular Diseases; Cardiovascular Risk Factor; Health Behavior

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Control (Standard Care)

NO INTERVENTION

Standard care during consultations. Advice and guidance offered by clinicians verbally and sometimes the addition of leaflets or a referral.

Intervention (Standard Care plus Lifestyle prescription - LRx)

EXPERIMENTAL

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)

Interventions

Lifestyle Prescription (LRx) BEHAVIORAL

Standard care during consultations with the addition of a physical lifestyle prescription

Intervention (Standard Care plus Lifestyle prescription - LRx)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and over
• Able and willing to provide written informed consent
• Understands written and spoken English
• Either an in/out- patient of Cardiology

You may not qualify if:

• Participant is unwilling or unable to provide written informed consent
• Participant is pregnant
• Participant has a drug dependency

Sponsors & Collaborators

• University of South Wales: lead
• Public Health Wales: collaborator
• Cwm Taf University Health Board: collaborator

Study Sites (1)

University of South Wales

Pontypridd, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 8, 2019
• Study Start: October 7, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2023
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)