Effect of Lifestyle Medicine Assessment Tool-Guided Counselling Compared to Usual Care Counselling in Adult Patients With Hypertension. A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change in systolic blood pressure
研究概览
简要总结
The goal of this clinical trial is to learn if knowing and understanding a patient's daily habits and then giving clear advice on what changes to make can help control blood pressure better than the routine way of advising people with high blood pressure. The main questions it aims to answer are:
- To learn if using the Lifestyle Medicine Assessment tool (A 21-item questionnaire) to understand the current lifestyle of people with hypertension and guide them accordingly, helps in lowering blood pressure more, as compared to routine advice?
- To see if this way of guiding patients results in more positive lifestyle changes than routine advice? Researchers will compare two groups of people with hypertension. One will be guided after assessing their current lifestyle with the Lifestyle Medicine Assessment Tool and one will be given routine guidance. The researchers will then see which group had better blood pressure control.
Participants will be:
• Asked a few questions about their lifestyle and then they will be advised accordingly on ways to make it better.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18-65 yrs with diagnosed primary/essential hypertension, defined as two or more clinic BP readings of ≥130/80 (ACC/AHA Guidelines).
- •If taking anti hypertensives, then on a stable regime i.e. no recent medication change for at least ≥4 weeks.
- •Willing and able to participate in the study.
排除标准
- •Diagnosed secondary hypertension.
- •Moderate to severe CKD (eGFR <60 ml/min/1.73m2).
- •Moderate to severe ischemic heart disease.
- •Diabetes Mellitus requiring insulin.
- •Major psychiatric disorder such as dementia or schizophrenia.
- •Pregnancy or Lactating mother.
- •Unable to participate in study/ Severe mobility limitation.
研究组 & 干预措施
Control Group
The patients in the control group will complete the LMA questionnaire and their scores will be noted without revealing them to the participants. They will receive the usual routine counselling comprised of advice to reduce salt intake and increase daily physical activity.
Intervention Group
Patients in the intervention group will complete the Lifestyle Medicine Assessment (LMA) questionnaire, and structured counselling will be delivered according to their scores in each domain. To keep the counselling consistent and standardized throughout the study a checklist will be formulated according to the current guidelines on lifestyle modification for hypertensive patients, consisting of counselling items pertaining to each domain, and it will be followed for all patients in the intervention group.
干预措施: Lifestyle Intervention (Behavioral)
结局指标
主要结局
Change in systolic blood pressure
时间窗: From enrolment to the end of follow-up at three months
Change in systolic blood pressure from baseline to the third month, measured at monthly intervals. The effect of the intervention will be evaluated as the difference in mean change between the intervention and control groups over time.
次要结局
- Change in lifestyle factors(From baseline to the three-month follow-up.)
- Patient satisfaction(At the end of three-month follow-up)
研究者
Dr. Hafiz Muhammad Abu Baker Mahmood
Principal Investigator
Indus Hospital and Health Network