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

• Sponsor: University of South Wales (Other)
• Overall Status: Suspended
• CT.gov ID: NCT04118673
• Collaborator: Public Health Wales (Other), Cwm Taf University Health Board (Other)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 39.8
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief 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).

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: The study is an interventional controlled observational study based in the Secondary 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) 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 Secondary 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) 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: Secondary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health (Phase II)
• Actual Study Start Date: Oct 7, 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) Standard care during consultations. Advice and guidance offered by clinicians verbally and sometimes the addition of leaflets or a referral.
Experimental: Intervention (Standard Care plus Lifestyle prescription - LRx) Standard care during consultations with the addition of a physical lifestyle prescription. Advice and guidance will be offered by clinicians verbally, whilst being supported with a lifestyle prescription and a possible referral if required.	Behavioral: Lifestyle Prescription (LRx); Standard care during consultations with the addition of a physical lifestyle prescription

Outcome Measures

Primary Outcome Measures

1. A prescription (LRx) being issued during a consultation [During month 7 of the study]

   Number of so-signed prescription (LRx) forms. Total number of forms to be co-signed = 60

2. 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). Scale: 7 (minimum) to 41 (maximum). A lower value represents a better (more positive) outcome.

3. Healthcare practitioner (HCP) view of the prescription (LRx) and consultation questionnaire. [During month 7 of the study]

   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

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 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

Contacts and Locations

Locations

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

Sponsors and Collaborators

• University of South Wales
• Public Health Wales
• Cwm Taf University Health Board

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of South Wales
• ClinicalTrials.gov Identifier: NCT04118673
• Other Study ID Numbers: 260481
• First Posted: Oct 8, 2019
• Last Update Posted: Jun 30, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

No Results Posted as of Jun 30, 2021