Clinical Trials Logo

Clinical Trial Summary

Hypertension (HT) is an important risk factor for stroke, coronary heart disease (CHD), heart failure and renal diseases, and the leading risk factor of global disease burden. A multitude of interventions have proven efficacy in lowering blood pressure and reducing long term HT complications, including pharmacologic treatment, DASH diet (Dietary Approaches to Stop Hypertension), exercise, weight reduction, smoking cessation, alcohol moderation and self-monitoring of blood pressure.

Objectives:

To evaluate long-term effectiveness and cost-effectiveness of Risk-Assessment-and-Management-Programme-for-Hypertension (RAMP-HT), a multi-disciplinary structured service to enhance quality of hypertension care in primary care compared to usual care

Hypotheses:

1. RAMP-HT is effective in reducing HT complications, based on previous results showing RAMP-HT was effective in improving patients' blood pressure

2. RAMP-HT is cost-effective

Design and Subjects:

Retrospective study of 5-year longitudinal data on matched cohorts of public primary care patients with uncontrolled HT under RAMP-HT and usual care will be conducted to evaluate long-term effectiveness and direct medical costs. Results from the long-term effectiveness and costing analyses will be applied to Markov modeling to determine the life time cost-effectiveness of RAMP-HT.

Main outcome measures:

1. 5-year incidence of cardiovascular complications

2. Direct medical costs of RAMP-HT and usual care HT patients

3. Incremental cost-effectiveness ratio (ICER) of cost per quality-adjusted life year (QALY) gained by RAMP-HT compared to usual care

Data analysis:

Cox regression will be performed to estimate the effect of RAMP-HT on the development of HT complication adjusted for baseline covariates. Descriptive statistics will be used to calculate costs of RAMP-HT and annual direct medical costs for HT patients. Markov modeling will be used to simulate 2 patient cohorts (RAMP-HT versus usual care) to estimate the respective lifetime direct medical costs and QALY gained/person. Cost/QALY of RAMP-HT will be compared to that of usual care to determine the ICER.

Expected results:

The results can provide evidence on the effectiveness and cost-effectiveness of RAMP-HT for primary care patients with uncontrolled HT, which can inform health policy and service planning.


Clinical Trial Description

Aim and objectives:

The aim of this study is to evaluate the cost-effectiveness of the RAMP-HT of the HA in primary care patients with uncontrolled hypertension.

The objectives are to:

1. Evaluate the long term (5-year) effectiveness of RAMP-HT compared to usual care in reducing cardiovascular complications, end-stage renal disease and all-cause mortalities in a cohort of primary care patients with uncontrolled hypertension at baseline

2. Estimate the direct medical cost of RAMP-HT and other health services among primary care HT patients with or without complications

3. Evaluate the cost-effectiveness of RAMP-HT, compared to usual care, in gaining one QALY in primary care patients with uncontrolled hypertension

Hypotheses:

1. RAMP-HT is more effective in reducing 5-year cardiovascular complications, end stage renal disease and all-cause mortality among primary care patients with uncontrolled hypertension compared to usual care

2. The direct medical cost of RAMP-HT patients, for the same disease complication status, is not higher than that of usual care except for the RAMP-HT cost

3. The direct medical cost of HT patients with one or more complications is higher than that of HT patients without any complication

4. RAMP-HT is cost-effective compared to usual care, i.e. ICER per QALY gained is below the threshold value of 1 annual GDP (Gross Domestic Product) per capita of Hong Kong, which is the benchmark recommended by the World Health Organization ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03301194
Study type Observational
Source The University of Hong Kong
Contact
Status Completed
Phase
Start date August 1, 2016
Completion date January 31, 2019

See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A