HypertensionIMPLEMENT-HTNCT07914283
Implementation of a Person-Centered and Integrated Care Pathway for Hypertension
A study testing Educational intervention for doctors and nurses in people with Hypertension, run by Region Stockholm.
Trial summary
The aim is to investigate whether information and educational initiatives on the Swedish national care pathway for hypertension, directed at primary care centers, lead to an increase in the proportion of patients achieving target blood pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Educational intervention for doctors and nurses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Publicly funded primary care centers within Stockholm Region (SLSO)
Who cannot join
- Not applicable
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Implementation of a Person-Centered and Integrated Care Pathway for Hypertension: a Cluster-Randomized Trial
The aim is to investigate whether information and educational initiatives on the Swedish national care pathway for hypertension, directed at primary care centers, lead to an increase in the proportion of patients achieving target blood pressure.
Read the detailed description
Intervention: Information and educational initiatives on the national care pathway for hypertension, including specific recommendations regarding treatment and the use of digital support tools Study sites: Publicly funded primary care centers within Stockholm Region (SLSO) Study period: Primary analysis covering 2025-2028. Data extraction covering the period 2020-2028 Design: Stepped-wedge cluster-randomized trial Number of study units: Sixteen primary care centers will receive the intervention every 6 months during the period January 2027 to December 2028, for a total of 64 primary care centers.
Condition: Hypertension
Inclusion criteria: Publicly funded primary care centers within Stockholm Region (SLSO)
Exclusion criteria: Not applicable
Control group: Primary care centers that have not yet received the intervention serve as controls until they receive the intervention.
Definition of hypertension: Listed patients 18 years or above with a diagnosis of hypertension (ICD-10 I10-I15) during the last five years
Pre-defined subgroup analyses: Sex and age group (18-79, 80+ years)
- Conditions
- Hypertension
- Being tested
- Educational intervention for doctors and nurses
- Keywords
- Cluster randomized trial, Stepped-wedge cluster-randomized trial, Educational intervention
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational intervention for doctors and nursesOther
Educational intervention for doctors and nurses. Information and educational initiatives on the national care pathway for hypertension, including specific recommendations regarding treatment and the use of digital support tools. The intervention consists of in-person lectures by a physician educator, combined with an information package for physicians, nurses and patients. This includes standardised treatment algorithms with early combination therapy. Educational material will be made available electronically. Primary care centers will be provided with tools for continuous monitoring of their performance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Educational intervention for doctors and nurses. Receives: Other: Educational intervention for doctors and nurses |
| Control | No intervention | Control arm where each primary care unit is considered a control prior to the intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the proportion of patients with blood pressure <130/<80 mmHg
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.
Measured: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Secondary outcomes (13)
Change from baseline in the proportion of patients with their blood pressure measured
Proportion of patients with a diagnosis of hypertension who, in each 6-month interval had their blood pressure measured
Measured: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Change from baseline in the proportion of patients who were dispensed statin therapy
Proportion of patients with a diagnosis of hypertension who were dispensed statin therapy
Measured: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
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
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.
Measured: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Change from baseline in the proportion of patients who were dispensed combination therapy with antihypertensive agents
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)
Measured: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Change from baseline in the proportion of patients who achieved LDL cholesterol targets according to the ESC guidelines
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).
Measured: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Observed population trajectory of the proportion of patients with hypertension below 130/80 mmHg
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.
Measured: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Change from baseline in proportion of patients with uncontrolled blood pressure that received treatment intensification
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)
Measured: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Change in last measured systolic BP in mmHg per patient period
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.
Measured: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Mean number of primary care contacts per patient
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.
Measured: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Mean number of laboratory tests per patient
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.
Measured: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Mean number of blood pressure measurements per patient
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.
Measured: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Mean dispensed defined daily doses (DDDs) per patient
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.
Measured: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Mean pharmacy cost per patient
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.
Measured: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge cluster randomized trial of 16 primary care centers in 4 sequences for a total of 64 centers.
- Masking
- None (open label)
- Enrolment
- 120,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Tomas Forslund, MD PhD, Principal investigator, Region Stockholm, Karolinska InstitutetJonas Spaak, MD PhD, Principal investigator, Region Stockholm, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914283
- Sponsor's protocol ID
- 2026-02456-01
- Other IDs
- FoUI-1023544, FoUI-1043877
- Acronym
- IMPLEMENT-HT
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur J Prev Cardiol. 2022 Feb 19;29(1):5-115. doi: 10.1093/eurjpc/zwab154. No abstract available.
PubMed 34558602Mancia G, Kreutz R, Brunstrom M, Burnier M, Grassi G, Januszewicz A, Muiesan ML, Tsioufis K, Agabiti-Rosei E, Algharably EAE, Azizi M, Benetos A, Borghi C, Hitij JB, Cifkova R, Coca A, Cornelissen V, Cruickshank JK, Cunha PG, Danser AHJ, Pinho RM, Delles C, Dominiczak AF, Dorobantu M, Doumas M, Fernandez-Alfonso MS, Halimi JM, Jarai Z, Jelakovic B, Jordan J, Kuznetsova T, Laurent S, Lovic D, Lurbe E, Mahfoud F, Manolis A, Miglinas M, Narkiewicz K, Niiranen T, Palatini P, Parati G, Pathak A, Persu A, Polonia J, Redon J, Sarafidis P, Schmieder R, Spronck B, Stabouli S, Stergiou G, Taddei S, Thomopoulos C, Tomaszewski M, Van de Borne P, Wanner C, Weber T, Williams B, Zhang ZY, Kjeldsen SE. 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA). J Hypertens. 2023 Dec 1;41(12):1874-2071. doi: 10.1097/HJH.0000000000003480. Epub 2023 Sep 26.
PubMed 37345492
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Person-Centered and Integrated Care Pathway for Hypertension: a Cluster-Randomized Trial
- ClinicalTrials.gov ID
- NCT07914283
- Acronym / sponsor ID
- IMPLEMENT-HT / 2026-02456-01
- Conditions
- Hypertension
- Keywords
- Cluster randomized trial, Stepped-wedge cluster-randomized trial, Educational intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120,000 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to investigate whether information and educational initiatives on the Swedish national care pathway for hypertension, directed at primary care centers, lead to an increase in the proportion of patients achieving target blood pressure.
Detailed description
Intervention: Information and educational initiatives on the national care pathway for hypertension, including specific recommendations regarding treatment and the use of digital support tools Study sites: Publicly funded primary care centers within Stockholm Region (SLSO) Study period: Primary analysis covering 2025-2028. Data extraction covering the period 2020-2028 Design: Stepped-wedge cluster-randomized trial Number of study units: Sixteen primary care centers will receive the intervention every 6 months during the period January 2027 to December 2028, for a total of 64 primary care centers.
Condition: Hypertension
Inclusion criteria: Publicly funded primary care centers within Stockholm Region (SLSO)
Exclusion criteria: Not applicable
Control group: Primary care centers that have not yet received the intervention serve as controls until they receive the intervention.
Definition of hypertension: Listed patients 18 years or above with a diagnosis of hypertension (ICD-10 I10-I15) during the last five years
Pre-defined subgroup analyses: Sex and age group (18-79, 80+ years)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge cluster randomized trial of 16 primary care centers in 4 sequences for a total of 64 centers.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Educational intervention for doctors and nursesEducational intervention for doctors and nurses. |
| Control | No intervention | –Control arm where each primary care unit is considered a control prior to the intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Publicly funded primary care centers within Stockholm Region (SLSO)
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational intervention for doctors and nursesEducational intervention for doctors and nurses. Information and educational initiatives on the national care pathway for hypertension, including specific recommendations regarding treatment and the use of digital support tools. The intervention consists of in-person lectures by a physician educator, combined with an information package for physicians, nurses and patients. This includes standardised treatment algorithms with early combination therapy. Educational material will be made available electronically. Primary care centers will be provided with tools for continuous monitoring of their performance. | Other | Intervention |
Primary outcome
Change from baseline in the proportion of patients with blood pressure <130/<80 mmHg
Time frame: 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.
13 secondary outcomes
Change from baseline in the proportion of patients with their blood pressure measured
Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Change from baseline in the proportion of patients who were dispensed statin therapy
Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
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
Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Change from baseline in the proportion of patients who were dispensed combination therapy with antihypertensive agents
Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Change from baseline in the proportion of patients who achieved LDL cholesterol targets according to the ESC guidelines
Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Observed population trajectory of the proportion of patients with hypertension below 130/80 mmHg
Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Change from baseline in proportion of patients with uncontrolled blood pressure that received treatment intensification
Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Change in last measured systolic BP in mmHg per patient period
Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Mean number of primary care contacts per patient
Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Mean number of laboratory tests per patient
Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Mean number of blood pressure measurements per patient
Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Mean dispensed defined daily doses (DDDs) per patient
Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Mean pharmacy cost per patient
Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 34558602Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur J Prev Cardiol. 2022 Feb 19;29(1):5-115. doi: 10.1093/eurjpc/zwab154. No abstract available.
- Background: PubMed 37345492Mancia G, Kreutz R, Brunstrom M, Burnier M, Grassi G, Januszewicz A, Muiesan ML, Tsioufis K, Agabiti-Rosei E, Algharably EAE, Azizi M, Benetos A, Borghi C, Hitij JB, Cifkova R, Coca A, Cornelissen V, Cruickshank JK, Cunha PG, Danser AHJ, Pinho RM, Delles C, Dominiczak AF, Dorobantu M, Doumas M, Fernandez-Alfonso MS, Halimi JM, Jarai Z, Jelakovic B, Jordan J, Kuznetsova T, Laurent S, Lovic D, Lurbe E, Mahfoud F, Manolis A, Miglinas M, Narkiewicz K, Niiranen T, Palatini P, Parati G, Pathak A, Persu A, Polonia J, Redon J, Sarafidis P, Schmieder R, Spronck B, Stabouli S, Stergiou G, Taddei S, Thomopoulos C, Tomaszewski M, Van de Borne P, Wanner C, Weber T, Williams B, Zhang ZY, Kjeldsen SE. 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Association (ERA). J Hypertens. 2023 Dec 1;41(12):1874-2071. doi: 10.1097/HJH.0000000000003480. Epub 2023 Sep 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tomas Forslund, MD PhD principal investigator
Region Stockholm, Karolinska Institutet
Jonas Spaak, MD PhD principal investigator
Region Stockholm, Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention for doctors and nurses in people with Hypertension, run by Region Stockholm.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tomas Forslund, MD PhD (+46(0)812355000, tomas.forslund.1@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the proportion of patients with blood pressure <130/<80 mmHg (time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07914283, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.