跳至主要内容
临床试验/NCT04118673
NCT04118673终止不适用

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

University of South Wales1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
38
试验地点
1
主要终点
A prescription (LRx) being issued during a consultation

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 and over
  • Able and willing to provide written informed consent
  • Understands written and spoken English
  • Either an in/out- patient of Cardiology

排除标准

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

结局指标

主要结局

A prescription (LRx) being issued during a consultation

时间窗: 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

时间窗: 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.

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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