Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health (P-PLAC 2)

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

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).

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Wales
    • Pontypridd, Wales, United Kingdom, CF37 1DL
      • University of South Wales

Participation Criteria

Eligibility Criteria

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

Description

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.

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 during consultations.
Experimental: Intervention; Standard care during consultations with the addition of a physical lifestyle prescription.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A prescription (LRx) being issued during a consultation	Number of a co- signed prescription (LRx) forms. Total number of forms to be co-signed = 120.	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) - control vs interventional group. Initials responses from the questionnaires will be compared with the participants 3mth post consultation questionnaire to establish if they acted upon the guidance offered, and if they're thought and feelings had changed during the time. 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 questionnaires. Total number of questionnaires to be completed = 12. 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 1 to 3: 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 (NHS)

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 260480

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