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

NCT ID: NCT04118673

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-07

Study Completion Date

2023-03-31

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).

Detailed Description

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Conditions

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Cardiovascular Diseases Cardiovascular Risk Factor Health Behavior

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control (Standard Care)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Lifestyle Prescription (LRx)

Intervention Type BEHAVIORAL

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

Interventions

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Lifestyle Prescription (LRx)

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Public Health Wales

OTHER_GOV

Sponsor Role collaborator

Cwm Taf University Health Board

UNKNOWN

Sponsor Role collaborator

University of South Wales

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of South Wales

Pontypridd, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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260481

Identifier Type: -

Identifier Source: org_study_id

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