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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04118673
Acronym
S-PLAC 2
Enrollment
38
Registered
2019-10-08
Start date
2019-10-07
Completion date
2023-03-31
Last updated
2025-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Cardiovascular Risk Factor, Health Behavior

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).

Interventions

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

Sponsors

Public Health Wales
CollaboratorOTHER_GOV
Cwm Taf University Health Board
CollaboratorUNKNOWN
University of South Wales
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
A prescription (LRx) being issued during a consultationDuring month 7 of the studyNumber of so-signed prescription (LRx) forms. Total number of forms to be co-signed = 60
Patient view of the prescription (LRx) and consultation QuestionnaireDuring month 7 of the studyCompleted 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 studyCompleted 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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026