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Not yet recruitingNCT07914283IMPLEMENT-HTUpdated Nov 3, 2026

Implementation of a Person-Centered and Integrated Care Pathway for Hypertension

An interventional study of Educational intervention for doctors and nurses in Hypertension, sponsored by Region Stockholm. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Region Stockholm · Not applicable, Interventional, and Treatment

Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
120,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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)

02

Conditions studied

  • Hypertension

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Keywords

  • Cluster randomized trial
  • Stepped-wedge cluster-randomized trial
  • Educational intervention
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 120,000 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Region Stockholm is the lead sponsor of 121 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Publicly funded primary care centers within Stockholm Region (SLSO)

Exclusion criteria

Exclusion Criteria:

Not applicable

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
120,000 participants (estimated)

Study arms

  • Experimental
    Intervention

    Educational intervention for doctors and nurses.

    Other: Educational intervention for doctors and nurses

  • No intervention
    Control

    Control arm where each primary care unit is considered a control prior to the intervention

Interventions

  • OtherEducational intervention for doctors and nurses

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods

Secondary outcomes

  1. 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

    Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods

  2. 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

    Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods

  3. 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.

    Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods

  4. 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)

    Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods

  5. 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).

    Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods

  6. 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.

    Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods

  7. 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)

    Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods

  8. 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.

    Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods

  9. 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.

    Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods

  10. 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.

    Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods

  11. 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.

    Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods

  12. 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.

    Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods

  13. 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.

    Time frame: 6-month intervals consisting of 2 control periods, 1 baseline period and 4 intervention periods

Other outcomes

  1. Adverse drug reactions related to antihypertensive medication

    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.

    Time frame: 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

  2. Myocardial infarction and stroke

    Hypertension-related complications: myocardial infarction and stroke

    Time frame: 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

  3. All-cause mortality

    All-cause mortality

    Time frame: 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

07

Study locations

No study locations are listed for this record.

08

References and documents

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 34558602 ↗
  • Mancia 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 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Dec 2028, 23 months later.

Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 23 months is close to that.

Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Nov 3, 2026
StartEst.
Jan 1, 2027
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07914283
Lead sponsor
Region Stockholm
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

Tomas Forslund, MD PhD
Contact
tomas.forslund.1@ki.se
+46(0)812355000
Jonas Spaak, MD PhD
Contact
jonas.spaak@ki.se
+46(0)812355000
Tomas Forslund, MD PhD
principal investigator · Region Stockholm, Karolinska Institutet
Jonas Spaak, MD PhD
principal investigator · Region Stockholm, Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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