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Clinical Trials/NCT04118673
NCT04118673TerminatedNot Applicable

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

University of South Wales1 site in 1 country38 target enrollmentStarted: October 7, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
38
Locations
1
Primary Endpoint
A prescription (LRx) being issued during a consultation

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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). 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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