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

Sponsor

University of South Wales (Other)

Overall Status

Suspended

CT.gov ID

NCT04113213

Collaborator

Public Health Wales (Other), Cwm Taf University Health Board (NHS) (Other)

240

Enrollment

Location

Arms

39.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Behavior Change Interventions Cardiovascular Diseases Cardiovascular Risk Factor Behavior, Health	Behavioral: Lifestyle Prescription (LRx)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 5, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

A prescription (LRx) being issued during a consultation [During month 7 of the study]
Number of a co- signed prescription (LRx) forms. Total number of forms to be co-signed = 120.
Patient view of the prescription (LRx) and consultation Questionnaire [During month 7 of the study]
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.
Healthcare Practitioner (HCP) view of the prescription (LRx) and consultation Questionnaire [during month 7 of the study]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Wales	Pontypridd	Wales	United Kingdom	CF37 1DL

Sponsors and Collaborators

University of South Wales
Public Health Wales
Cwm Taf University Health Board (NHS)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of South Wales

ClinicalTrials.gov Identifier:

NCT04113213

Other Study ID Numbers:

260480

First Posted:

Oct 2, 2019

Last Update Posted:

Jun 30, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Jun 30, 2021