Secondary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health (S-PLAC 2)

Cardiovascular Diseases Clinical Trial

— S-PLAC 2  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04118673
• Other study ID #: 260481
• Status: Suspended
• Phase: N/A
• Start date: October 7, 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 have cardiovascular disease (CVD) may be an extremely cost effective mechanism of improving health individually and for the NHS. Positive lifestyle changes such as improved diet, increased physical activity, quitting smoking and reducing alcohol consumption have been proven to reform the health status of individuals with CVD. S-PLAC 2 is a phase II study to determine the efficacy of a lifestyle prescription (L℞) in patients and healthcare practitioners in a secondary care setting (i.e. hospital clinics/wards).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 120
• 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 written and spoken English
• Either an in/out- patient of Cardiology

Exclusion Criteria:

• Participant is unwilling or unable to provide written informed consent
• Participant is pregnant
• Participant has a drug dependency

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor
• Health Behavior

Intervention

Behavioral:
• Lifestyle Prescription (LRx)
Standard care during consultations with the addition of a physical lifestyle prescription

Locations

Country	Name	City	State
United Kingdom	University of South Wales	Pontypridd

Sponsors (3)

Lead Sponsor	Collaborator
University of South Wales	Cwm Taf University Health Board, 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 so-signed prescription (LRx) forms. Total number of forms to be co-signed = 60	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).; 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 questionnaire. Total number of questionnaires to be completed = 6. 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: 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