Hypertension, cardiovascular diseases Circulatory System Cardiovascular diseases
Conditions
Interventions
QUICK-I:
Observational research. In a rural clinic in Nigeria, participating in the Hygeia Community Health Plan insurance scheme, 300 patients at risk for development of CVD (patients with hypertensi
Sponsors
Health Insurance Fund (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: QUICK-I: All of the following inclusion criteria: 1. Aged greater than or equal to 18 years of age, either sex 2. Visiting the outpatient site clinic/admitted to the site clinic 3. Hygeia Community Health Plan insurance 4. One of the following: 4.1. Diagnosis of hypertension 4.2. Diagnosis of diabetes mellitus 4.3. Established cardiovascular disease 4.4. Diagnosis of renal disease QUICK-II: Part 1 (development CHEP): 1. 30 patients with hypertension 2. 10 members of the hospital staff 3. 5 - 10 managers and doctors from the health insurance company Part 2 (measurement patient adherence): 4. Enrolled in HCHP insurance plan 5. Having been included in QUICK-I for at least 8 months 6. Diagnosis hypertension 7. Either: 7.1. Uncontrolled blood pressure (greater than or equal to 140 mmHg systolic or greater than or equal to 90 mmHg diastolic), or 7.2. Non-adherent to any prescribed medication for cardiovascular risk factors and cardiovascular disease (CVD) according to Morisky scale
Exclusion criteria
Exclusion criteria: QUICK-I + QUICK-II: 1. Unwilling to provide consent for data-collection 2. All pregnant or lactating females 3. Suspected secondary hypertension 4. Any person who is incapable of giving informed consent 5. Patients who are not likely to complete the follow up period (for example nomads)
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| QUICK-I: 1. The proportion of patients in whom CVD risk factor treatment is successful at one year of follow up. In addition, the proportion of patients successfully treated will be determined per risk factor. 2. Description of characteristics of responders to treatment and non responders to treatment after one year of follow up 3. The proportion of patients with target organ damage at baseline and at one year of follow up 4. The proportion of patients with CVD at baseline and at one year of follow up (new and recurrent CVD events) 5. Incidence of all cause mortality in the project population during one year of follow up 6. Score on the 12-item short form health survey (SF-12) quality of life questionnaire at baseline and after one year of follow up 7. Score on the 8-item Morisky Medication Adherence Scale at three, six, nine months and one year of follow up 8. The proportion of patients who report side effects during one year of follow up and description of the most frequent reported side effects of CVD preventive drugs during one year of follow up 9. The association between baseline serum creatine kinase (CK) and the reduction in blood pressure after drug treatment at 6 months and one year of follow up 10. The association between the changes in blood pressure after drug treatment and the changes in serum CK at 1 year of follow up compared to baseline All secondary endpoints are assessed after completion of follow up of the entire QUICK-I cohort (the last patient is estimated to complete follow up 1.5 years after inclusion of the first patient). Assessment is estimated to be completed 6 months after completion of the cohort follow up time. QUICK-II: Part 2 only, measured at 6 months after baseline: 1. Changes with respect to physiological measures ? systolic blood pressure, diastolic blood pressure, and body mass index (BMI) 2. Changes in other factors that may influence patients' hypertension management 3. The presence of self-reported additional cardiovascula | — |
Primary
| Measure | Time frame |
|---|---|
| QUICK-I: 1. The adjusted cardiovascular care quality score based on the United Kingdom National Health Services Quality and Outcome framework (NHS QOF) after the implementation of the CVD prevention program 2. The range of possible costs of CVD prevention treatment per patient per year, divided per category (treatment, consultation etc): 2.1. For the insurance company considering the current benefit package 2.2. For the hospital 2.3. For the patient 2.4. Costs outside the scope of this particular insurance program (for example costs when using different benefit packages/treatment regimes) 3. The estimated resources required for CVD prevention per year related to the total yearly medical pay out of the insurance company 4. The estimated net health care costs of a CVD prevention program per quality adjusted life year gained in a community health insurance setting All primary endpoints are assessed after completion of follow up of the entire cohort (the last patient is estimated to complete follow up 1.5 years after inclusion of the first patient). Assessment is estimated to be completed 6 months after completion of the cohort follow up time. QUICK-II: Part 1: Development of CHEP. This will be completed after completion of the follow up period of the QUICK-I cohort (estimated 1.5 years after inclusion of the first patient in QUICK-I). Part 2: Level of adherence to medication at 6 months after the implementation of CHEP minus level of adherence to medication at baseline as measured by the 8 item Morisky adherence scale. The primary endpoint will be assessed after completion of the follow up period of the entire QUICK-II cohort. This is estimated to be one year after the inclusion of the first patient in the QUICK-II cohort. | — |
Countries
Nigeria
Outcome results
None listed