Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health

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

SUSPENDED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-05

Study Completion Date

2023-01-31

Brief Summary

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Prescribing lifestyle changes to patients who are at risk of cardiovascular disease, may be an extremely cost effective mechanism of improving health for the individual themselves and the NHS. It is already proven that positive lifestyle changes such as improved diet, increased physical activity, quitting smoking and reducing alcohol consumption can lower the risk of cardiovascular disease, as well as reduce the risk of all-cause mortality.

P-PLAC2 (Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health) is a Phase II interventional study to determine the efficacy of a Lifestyle Prescription (LRx), from the viewpoint of patients and healthcare practitioners. The study uses a mixed methods design, and full study training and support will be provided to staff involved in the recruitment of patients, through to the behaviour change consultation, and end of study.

If the study proves successful, a lifestyle prescription (LRx) could then be made available to support NHS staff throughout all disciplines (specifically those working with patients who are at risk of cardiovascular disease (CVD).

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Detailed Description

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Conditions

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Behavior Change Interventions Cardiovascular Diseases Cardiovascular Risk Factor Behavior, Health

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

The study is an interventional controlled observational study based in the Primary 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 - from 12months) 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 during consultations.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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

Group Type EXPERIMENTAL

Lifestyle Prescription (LRx)

Intervention Type BEHAVIORAL

Lifestyle prescription, based on the UK WP10 medicinal prescription form. Includes advice and guidance regarding physical activity, diet, smoking and alcohol consumption.

Interventions

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Lifestyle Prescription (LRx)

Lifestyle prescription, based on the UK WP10 medicinal prescription form. Includes advice and guidance regarding physical activity, diet, smoking and alcohol consumption.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 18 and over.
* Able and willing to provide written informed consent.
* Understands spoken and written English.

Exclusion Criteria

* Participant is unwilling or unable to provide written informed consent.
* Participant is pregnant.
* Participant has a diagnosed psychological disorder.
* Participant has a drug dependency.
* Participant is housebound, or resides in a nursing home.
* Participant has behavioural issues or learning difficulties.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes