Clinical trial NCT04113213: Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health
Official title: Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health (Phase II)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Behavior Change Interventions
Cardiovascular Diseases
Cardiovascular Risk Factor
Behavior, Health
Lead sponsor: University of South Wales
Sponsor class: OTHER
Collaborators: name: Public Health Wales
name: Cwm Taf University Health Board (NHS)
First posted: 2019-10-02
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: PREVENTION

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).


Eligibility criteria: 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.

Primary outcomes:
measure: A prescription (LRx) being issued during a consultation
timeFrame: During month 7 of the study
measure: Patient view of the prescription (LRx) and consultation Questionnaire
timeFrame: During month 7 of the study
measure: Healthcare Practitioner (HCP) view of the prescription (LRx) and consultation Questionnaire
timeFrame: during month 7 of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Pontypridd
country: United Kingdom
facility: University of South Wales
state: Wales
Study officials:
References: