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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04118673
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : November 20, 2019
Sponsor:
Collaborators:
Public Health Wales
Cwm Taf University Health Board
Information provided by (Responsible Party):
University of South Wales

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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Secondary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health (Phase II)
Actual Study Start Date : October 7, 2019
Estimated Primary Completion Date : June 7, 2020
Estimated Study Completion Date : July 7, 2020

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




Primary Outcome Measures :
  1. A prescription (LRx) being issued during a consultation [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118673


Locations
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United Kingdom
University of South Wales Recruiting
Pontypridd, United Kingdom
Contact: Hannah Parry, MSc.    01443 483893    hannah.parry@southwales.ac.uk   
Contact: Mark Williams, PhD.    01443 483893    mark.williams@southwales.ac.uk   
Principal Investigator: Hannah Parry, MSc.         
Sponsors and Collaborators
University of South Wales
Public Health Wales
Cwm Taf University Health Board

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Responsible Party: University of South Wales
ClinicalTrials.gov Identifier: NCT04118673    
Other Study ID Numbers: 260481
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases