Trial · NCT07914283
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in the proportion of patients with blood pressure <130/<80 mmHg | 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods | Proportion of patients with a diagnosis of hypertension and at least one blood pressure recorded in 6-month intervals whose last recorded blood pressure was below the target according to the person-centered and integrated care pathway (PSVF) for hypertension (\<130/\<80 mmHg), irrespective of measurement method (office, home, or ambulatory blood pressure monitoring). The outcome is assessed in each 6-month interval, and the primary effect measure is the average effect over the first 12 months after each center's scheduled crossover. |
| Secondary | Change from baseline in the proportion of patients with their blood pressure measured | 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods | Proportion of patients with a diagnosis of hypertension who, in each 6-month interval had their blood pressure measured |
| Secondary | Change from baseline in the proportion of patients who were dispensed statin therapy | 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods | Proportion of patients with a diagnosis of hypertension who were dispensed statin therapy |
| Secondary | Change from baseline in the proportion of patients who achieved an office blood pressure <140/<90 mmHg, a home blood pressure <135/<85 mmHg, or an ambulatory blood pressure <135/<85 mmHg | 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods | Proportion of patients with a diagnosis of hypertension and at least one blood pressure recorded in 6-month intervals who achieved an office blood pressure \<140/\<90 mmHg, a home blood pressure \<135/\<85 mmHg, or an ambulatory blood pressure \<135/\<85 mmHg. The outcome is assessed in each 6-month interval, and the effect measure is the average effect over the first 12 months after each center's scheduled crossover. |
| Secondary | Change from baseline in the proportion of patients who were dispensed combination therapy with antihypertensive agents | 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods | Proportion of patients with a diagnosis of hypertension and at least one blood pressure recorded in the 6-month interval who were dispensed combination therapy with antihypertensive agents (2, 3, or more) |
| Secondary | Change from baseline in the proportion of patients who achieved LDL cholesterol targets according to the ESC guidelines | 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods | Proportion of patients with a diagnosis of hypertension and at least one blood pressure recorded in the 6-month interval who achieved LDL cholesterol targets according to the ESC guidelines (among patients with LDL cholesterol measured). Very high risk \<1.4 mmol/L; high risk \<1.8 mmol/L, moderate risk \<2.6 mmol/L). |
| Secondary | Observed population trajectory of the proportion of patients with hypertension below 130/80 mmHg | 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods | Observed population trajectory describing the proportion of patients with hypertension below the PSVF target 130/80 mmHg per half-year from H1-2025 to H2-2028, using the last blood pressure in that half-year. If no measurement is recorded, the most recent value during the last 12 months is carried forward. Missing values will be regarded as not treated to target. This is a descriptive series with no model terms and no p-values. It shows the total change in the population, combining the secular trend and the rollout. |
| Secondary | Change from baseline in proportion of patients with uncontrolled blood pressure that received treatment intensification | 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods | Proportion of patients with a diagnosis of hypertension and a last blood pressure \>= 130/80 mmHg in the 6-month interval who were dispensed combination therapy with antihypertensive agents (2, 3, or more) |
| Secondary | Change in last measured systolic BP in mmHg per patient period | 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods | Mean systolic blood pressure in patients with a diagnosis of hypertension and at least one blood pressure recorded in 6-month intervals. The outcome is assessed in each 6-month interval, and the effect measure is the average effect over the first 12 months after each center's scheduled crossover. |
| Secondary | Mean number of primary care contacts per patient | 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods | Resource utilization. Mean number of primary care contacts per patient per 6-month interval, by staff category, in total and with a hypertension diagnosis registered at the visit. Reported descriptively per sequence and period. |
| Secondary | Mean number of laboratory tests per patient | 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods | Resource utilization. Mean number of laboratory tests (creatinine, potassium, sodium, lipids) per patient per 6-month interval. Reported separately for each test type. Reported descriptively per sequence and period. |
| Secondary | Mean number of blood pressure measurements per patient | 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods | Resource utilization. Mean number of blood pressure measurements per patient per 6-month interval, by measurement type. Reported by measurement type (office, home, ambulatory). Reported descriptively per sequence and period. |
| Secondary | Mean dispensed defined daily doses (DDDs) per patient | 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods | Resource utilization. Mean dispensed defined daily doses (DDDs) of antihypertensives and statins per patient per 6-month interval. Reported separately for antihypertensive agents and statins. Reported descriptively per sequence and period. |
| Secondary | Mean pharmacy cost per patient | 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods | Resource utilization. Mean pharmacy cost of dispensed antihypertensives and statins per patient per 6-month interval. Reported separately for antihypertensive agents and statins. Reported descriptively per sequence and period. |
| Other | Adverse drug reactions related to antihypertensive medication | First event per patient and 6-month interval, analyzed as event rates per person-time and reported as a rate ratio averaged over the first 12 months after crossover | Safety outcome. Adverse drug reactions related to antihypertensive medication: acute kidney injury, hypotension or syncope, orthostatic hypotension, and fall injury. Based on hospitalizations with relevant ICD-10 codes. |
| Other | Myocardial infarction and stroke | First event per patient and 6-month interval, analyzed as event rates per person-time and reported as a rate ratio averaged over the first 12 months after crossover | Hypertension-related complications: myocardial infarction and stroke |
| Other | All-cause mortality | First event per patient and 6-month interval, analyzed as event rates per person-time and reported as a rate ratio averaged over the first 12 months after crossover | All-cause mortality |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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