Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health

Cardiovascular Diseases Clinical Trial

— P-PLAC 2  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04113213
• Other study ID #: 260480
• Status: Suspended
• Phase: N/A
• Start date: October 5, 2019
• Est. completion date: January 31, 2023

Study information

• Verified date: June 2021
• Source: University of South Wales
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 240
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Behavior Change Interventions
• Behavior, Health
• Cardiovascular Diseases
• Cardiovascular Risk Factor

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	University of South Wales	Pontypridd	Wales

Sponsors (3)

Lead Sponsor	Collaborator
University of South Wales	Cwm Taf University Health Board (NHS), Public Health Wales

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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