Effectiveness of Customized Interventions on Therapeutic Response and Quality of Life among the Adults with H hypertension attending medicine OPDs of selected hospital in Sikkim A Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Sikkim Manipal College of Nursing
- Enrollment
- 550
- Locations
- 1
- Primary Endpoint
- Serum homocysteine level and Blood pressure
Overview
Brief Summary
The current study is a Randomized Controlled Trial among the adults with H-hypertension attending medicine OPDs of selected hospital in Sikkim. The objectives are to assess the proportion of H-hypertension in phase 1 & in phase 2, to find the effectiveness of customized interventions on therapeutic response among the subjects in experimental group as compared to the control group at baseline, two, four and six months. The primary outcome is to reduce the serum homocysteine level among participants with H-hypertension thereby reducing the blood pressure & the secondary outcome is the controlled blood pressure may contribute towards maintaining the QoL of the participant, the adherence to antihypertensives and dietary practices will be emphasized so that it will also contribute positively towards reduction of homocysteine and control of hypertension and prevent complications leading to CADs, MI, Heart attack, Heart failure, Stroke and CKD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 19.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Phase 1 550 sample size Age 19-60 years willing to participate in the study Able to read and understand English Nepali language Phase 2 104 sample size Adults diagnosed to have H hypertension in phase 1 The participants will be randomized into experimental and control group 54 each in both group but it will be recalculated after the finding of the phase 1.
Exclusion Criteria
- •Phase 1 Hypertensive adults with comorbidities such as Coronary Artery Disease Myocardial Infarction Heart Failure Heart attack Stroke Diabetes Mellitus Chronic Kidney Disease Physical and or Mental disability Adults who are under folic acid and vitamin B supplementation adults with the report of serum homocysteine level more than 15micromole per liter Phase 2 Adults with Baseline systolic BP 180mmHg and diastolic BP 110mmHg Report of serum homocysteine level more than 15micromole per liter.
Outcomes
Primary Outcomes
Serum homocysteine level and Blood pressure
Time Frame: During enrollment to the study | 2nd month after intervention | 4th month after intervention | 6th month after intervention
Secondary Outcomes
- Adherence to antihypertensives(Adherence to dietary practices and Quality of Life)
Investigators
Wangkheimayum Ashalata Devi
Sikkim Manipal College of Nursing Sikkim Manipal University