Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health

NCT04113213 | Suspended

• 1 other identifier: 260480
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Control

NO INTERVENTION

Standard care during consultations.

Intervention

EXPERIMENTAL

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

Behavioral: Lifestyle Prescription (LRx)

Interventions

Lifestyle Prescription (LRx) BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Wales: lead
• Public Health Wales: collaborator
• Cwm Taf University Health Board (NHS): collaborator

Study Sites (1)

University of South Wales

Pontypridd, Wales, CF37 1DL, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: October 2, 2019
• Study Start: October 5, 2019
• Primary Completion: December 31, 2022
• Study Completion: January 31, 2023
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)