Effect of Counselling of Patients With Hypertension Presenting in Family Medicine Clinics Using Lifestyle Medicine Assessment Tool.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Indus Hospital and Health Network
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Change in systolic blood pressure
Overview
Brief Summary
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 is more satisfactory for them then 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.
- They will also be asked to measure their blood pressure at home and bring the record with them when they come for their doctor's visit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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. They will be required to keep, and bring with them at each visit, a home BP log comprising of two readings taken one minute apart, twice a day (total four readings daily) for a minimum of 3 to 7 (preferred) days before the consultation. At the end of the study they will complete a satisfaction questionnaire.
Intervention: Lifestyle Intervention (Behavioral)
Control Group
The patients in the control group will receive the usual routine care. They will be required to keep, and bring with them at each visit, a home BP log comprising of two readings taken one minute apart, twice a day (total four readings daily) for a minimum of 3 to 7 (preferred) days before the consultation. At the end of the study they will complete a satisfaction questionnaire.
Outcomes
Primary Outcomes
Change in systolic blood pressure
Time Frame: From enrolment to the end of follow-up at three months
Change in systolic blood pressure (clinic BP main and home BP supportive) 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.
Secondary Outcomes
- Patient satisfaction(At the end of three-month follow-up)
Investigators
Dr. Hafiz Muhammad Abu Bakar Mahmood
Principal Investigator
Indus Hospital and Health Network