Secondary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health (S-PLAC 2) (S-PLAC 2)
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|ClinicalTrials.gov Identifier: NCT04118673|
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : November 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Cardiovascular Risk Factor Health Behavior||Behavioral: Lifestyle Prescription (LRx)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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)|
|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|
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
- 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
- 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.
- 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).
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
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
|University of South Wales||Recruiting|
|Pontypridd, United Kingdom|
|Contact: Hannah Parry, MSc. 01443 483893 firstname.lastname@example.org|
|Contact: Mark Williams, PhD. 01443 483893 email@example.com|
|Principal Investigator: Hannah Parry, MSc.|