Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health (Phase II)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 240
- 试验地点
- 2
- 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 are at risk of cardiovascular disease, may be an extremely cost effective mechanism of improving health for the individual themselves and the NHS. It is already proven that positive lifestyle changes such as improved diet, increased physical activity, quitting smoking and reducing alcohol consumption can lower the risk of cardiovascular disease, as well as reduce the risk of all-cause mortality.
P-PLAC2 (Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health) is a Phase II interventional study to determine the efficacy of a Lifestyle Prescription (LRx), from the viewpoint of patients and healthcare practitioners. The study uses a mixed methods design, and full study training and support will be provided to staff involved in the recruitment of patients, through to the behaviour change consultation, and end of study.
If the study proves successful, a lifestyle prescription (LRx) could then be made available to support NHS staff throughout all disciplines (specifically those working with patients who are at risk of cardiovascular disease (CVD).
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
- 是
入选标准
- •Age 18 and over.
- •Able and willing to provide written informed consent.
- •Understands spoken and written English.
排除标准
- •Participant is unwilling or unable to provide written informed consent.
- •Participant is pregnant.
- •Participant has a diagnosed psychological disorder.
- •Participant has a drug dependency.
- •Participant is housebound, or resides in a nursing home.
- •Participant has behavioural issues or learning difficulties.
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 a co- signed prescription (LRx) forms. Total number of forms to be co-signed = 120.
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) - control vs interventional group. Initials responses from the questionnaires will be compared with the participants 3mth post consultation questionnaire to establish if they acted upon the guidance offered, and if they're thought and feelings had changed during the time. 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 questionnaires. Total number of questionnaires to be completed = 12. 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 1 to 3: 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