HypertensionDEPTHNCT07812350
Effectiveness and Cost-Effectiveness of a Digital Care Pathway and Asynchronous Communication for Patients With Hypertension
A study testing Digital care pathway for hypertension and Asynchronous communication with nurse in people with Hypertension, run by Wellbeing Services County of Pirkanmaa at 6 sites in Finland.
Trial summary
The goal of this clinical trial is to learn if digital care pathway (DCP) and digital non-real-time messaging, in other words, asynchronous communication (AC) with nurse works to treat high blood pressure in adults in primary care. It will also learn if DCP and AC are good value for money. Read more about this study
- Who is it for?
- Ages 30 to 74 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Digital care pathway for hypertension and Asynchronous communication with nurse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 6 sitesFinland
- Study dates
- 15 Oct 2026to Sep 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 30 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of hypertension for at least 3 months
- an office blood pressure of ≥140/90 mmHg at baseline
- access to a smartphone and the ability to use strong electronic identification for application login
- ability to measure home blood pressure
- ability to take care of the personal medication
Who cannot join
- unwillingness to participate in the study
- secondary hypertension or hypertensive crisis (office blood pressure >200/130 mmHg)
- atrial fibrillation
- stage 4 or 5 chronic kidney disease (eGFR <30 mL/min/1.73 m²)
- a life expectancy of less than 1 year
- pregnancy or breastfeeding
- a clearly impaired ability to use the study interventions or participate in the study, as determined by a healthcare professional (e.g., insufficient Finnish language proficiency, dementia, psychiatric illness, or sensory impairments)
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Finland6 sites, 6 recruiting
- Recruiting
Akaa health and social services centre, The Wellbeing Services County of Pirkanmaa
Akaa, Pirkanmaa
Teemu Ekola, MD, +358444863415, teemu.ekola@tuni.fi
Tuomas Koskela, Professor
- Recruiting
Sastamala health and social services centre, The Wellbeing Services County of Pirkanmaa
Sastamala, Pirkanmaa
Teemu Ekola, MD, +358444863415, teemu.ekola@tuni.fi
Tuomas Koskela, Professor
- Recruiting
Hatanpää health and social services centre, The Wellbeing Services County of Pirkanmaa
Tampere, Pirkanmaa
Teemu Ekola, MD, +358444863415, teemu.ekola@tuni.fi
Tuomas Koskela, Professor
- Recruiting
Hervanta health and social services centre, The Wellbeing Services County of Pirkanmaa
Tampere, Pirkanmaa
Teemu Ekola, MD, +358444863415, teemu.ekola@tuni.fi
Tuomas Koskela, Professor
- Recruiting
Linnainmaa health and social services centre, The Wellbeing Services County of Pirkanmaa
Tampere, Pirkanmaa
Teemu Ekola, MD, +358444863415, teemu.ekola@tuni.fi
Tuomas Koskela, Professor
- Recruiting
Valkeakoski health and social services centre, The Wellbeing Services County of Pirkanmaa
Valkeakoski, Pirkanmaa
Teemu Ekola, MD, +358444863415, teemu.ekola@tuni.fi
Tuomas Koskela, Professor
About this study
Official title: Digital Care Pathway and Asynchronous Communication for Primary Care Patients With Uncontrolled Hypertension: a Cluster-Randomized Controlled Trial
The goal of this clinical trial is to learn if digital care pathway (DCP) and digital non-real-time messaging, in other words, asynchronous communication (AC) with nurse works to treat high blood pressure in adults in primary care. It will also learn if DCP and AC are good value for money. The main questions it aims to answer are:
- Does DCP and AC lower systolic blood pressure?
- Are DCP and AC good value for money in treating high blood pressure? Researchers will compare usual care plus DCP and usual care plus DCP with AC to usual care only to see if DCP and AC works to treat high blood pressure.
Read more
Participants will:
- Get usual care or usual care plus DCP or usual care plus DCP with AC for 6 months
- Visit the study nurse at the start of the trial and after 6 months for checkup and tests which include usual laboratory tests for high blood pressure
- Answer online survey questions and measure their blood pressure at home for 4 days at the start of the trial and after 6 months
Read the detailed description
The study will be conducted as a prospective, cluster-randomized controlled trial in six primary healthcare centres within the Wellbeing Services County of Pirkanmaa, Finland. Randomization will be performed at the healthcare centre level, with two centres allocated to each study arm. Because of the nature of the interventions, neither participants nor healthcare professionals can be blinded to treatment allocation.
Before the study begins, one induction session will be organised at all participating healthcare centres. This session will give healthcare professionals information about the study protocol and recommendations for hypertension management. In addition, professionals working at centres allocated to the intervention arms will receive training in the use of the digital care pathway and asynchronous communication.
One nurse from each participating centre will be appointed as a part-time study nurse. The study nurses will be responsible for participant recruitment, conducting baseline and follow-up visits, and promoting study awareness within their respective healthcare centres. During the study, participants will be monitored either by the study nurse or by other healthcare professional familiar with the participant. Hypertension management is optimised in accordance with the participant's home blood pressure readings.
Participants will be recruited for the study over a period of 6-12 months. Data will be collected at baseline and at the end of the 6 month follow-up. Data sources will include study nurse assessments during study visits, electronic health records and registers of the Wellbeing Services County of Pirkanmaa, the digital care pathway, and electronic questionnaires via the REDCap digital research platform.
Based on power calculations, assuming a statistical power of 80 percent and a two-sided significance level of 0.05, a minimum of 182 participants per study arm is required to detect a between-group difference of at least 5 mmHg in the change in systolic blood pressure during follow-up (SD of change in systolic blood pressure 17 mmHg). Considering cluster randomization and participant dropout during follow-up, the target sample size is 200 participants per study arm, resulting in a total sample size of 600 participants.
The results will be presented as means and standard deviations (SDs) for continuous variables, and frequencies and percentages for categorical variables. Between-group comparisons will be conducted using Student's t-test for normally distributed continuous variables, the Mann-Whitney U test for non-normally distributed continuous variables, and Pearson's chi-squared test or Fisher's exact test for categorical variables. The effects of the interventions on change in systolic blood pressure will be analysed using regression-based methods that account for the clustered study design, such as linear mixed-effects model. According to the intention-to-treat principle, all participants recruited to the study will be included in the primary analyses, regardless of whether they remained in the study for the entire follow-up period. A two-sided p-value of less than 0.05 will be considered statistically significant. All statistical analyses will be performed using IBM SPSS Statistics software.
The cost-effectiveness of the interventions will be assessed by calculating the incremental cost-effectiveness ratio (ICER), based on differences in both costs and effectiveness between the study arms. Costs will be assessed from the healthcare system perspective.
- Conditions
- Hypertension
- Being tested
- Digital care pathway for hypertension, Asynchronous communication with nurse
- Keywords
- Digital Health, Mobile Applications, Primary Health Care, Telemedicine, High Blood Pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital care pathway for hypertensionDevice
Digital care pathway for hypertension is a web-based and mobile application that includes goal setting and education material for hypertension, entering home blood pressure values, medication list and medication intake, blood pressure self-test and self-care survey, reminders on measuring values, upcoming appointments and self-care guidance, motivational messages and diary.
Asynchronous communication with nurseDevice
Asynchronous communication means digital bidirectional non-real-time messaging between participant and nurse. It can be used with digital care pathway.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual Care for hypertension |
| Digital Care Pathway | Experimental | Usual Care + Digital Care Pathway for 6 months Receives: Device: Digital care pathway for hypertension |
| Digital Care Pathway and Asynchronous Communication | Experimental | Usual Care + Digital Care Pathway with Asynchronous Communication with nurse for 6 months Receives: Device: Digital care pathway for hypertension; Device: Asynchronous communication with nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Office Systolic Blood Pressure Level at 6 Months
Office systolic blood pressure is measured using a validated and calibrated blood pressure monitor in accordance with the 2024 European Society of Cardiology (ESC) guidelines. Three blood pressure measurements are taken by the study nurse during the office visit, and the average of the last two measurements is used as the participant's blood pressure level. If the blood pressure readings differ by more than 10 mmHg, additional measurements are taken.
Measured: Baseline and 6 months
Secondary outcomes (11)
Change from Baseline in the Home Systolic Blood Pressure Level at 6 Months
Home systolic blood pressure is measured using a validated blood pressure monitor listed in the STRIDE BP database, in accordance with the Finnish Current Care Guidelines for Hypertension. Participants measure their seated cuff blood pressure twice in the morning and twice in the evening for four consecutive days. The home blood pressure level is defined as the mean of all recorded measurements.
Measured: Baseline and 6 months
Proportion of Participants with Controlled Blood Pressure at 6 months
Controlled blood pressure is defined as an office blood pressure level <140/90 mmHg and a home blood pressure level <135/85 mmHg according to the Finnish Current Care Guidelines for Hypertension
Measured: 6 months
Change from Baseline in the Cardiovascular Disease Risk at 6 Months assessed by FINRISKI risk calculator
The FINRISKI calculator is based on data on risk factors and morbidity follow-up from participants in the FINRISKI study conducted in 1982, 1987, 1992, 2002 and 2007. Data on morbidity and mortality among study participants over the 10-year follow-up period were obtained from Finnish registers. The FINRISKI calculator provides a percentage score that indicates participant's risk of suffering a heart attack or a stroke over the next 10 years. The percentage ranges from 0 to 100 percent, and a higher value indicates a worse outcome.
Measured: Baseline and 6 months
Change from Baseline in the Cardiovascular Disease Risk at 6 Months assessed by Systematic Coronary Risk Evaluation 2 (SCORE2) risk calculator
The SCORE2 risk calculator provides an estimate of 10-year fatal and non-fatal cardiovascular disease risk for participants without previous CVD or diabetes aged 40-69 years in Europe. It gives a percentage score that ranges from 0 to 100 percent, and a higher value indicates a worse outcome.
Measured: Baseline and 6 months
Change from Baseline in Quality of Life at 6 Months
Health related quality of life is measured with the EuroQoL-5D-5L questionnaire. The EQ-5D-5L questionnaire consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1 no problems, 2 slight problems, 3 moderate problems, 4 severe problems and 5 extreme problems. The participant is asked to indicate his/her health state by ticking the box next to the most appropriate level in each of the five dimensions. A higher level on each dimension indicates poorer health. The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where participant rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Measured: Baseline and 6 months
Change from Baseline in Self-Care Preparedness Index at 6 Months
The Self-Care Preparedness Index is assessed by a questionnaire for participants. The questionnaire contains six questions about participant's self-care. The index ranges from -5 to +5. A higher number indicates a higher level of self-care preparedness.
Measured: Baseline and 6 months
Change from Baseline in Medication Adherence at 6 Months
Medication adherence is assessed by reviewing antihypertensive medication prescriptions issued and dispensed during the preceding 6 months. Prescription data will be obtained from the electronic health record system with the participant's consent. More prescriptions dispensed as instructed by a doctor means better outcome. The value can range from 0 percent of prescriptions dispensed to 100 percent prescriptions dispensed as instructed.
Measured: Baseline and 6 months
Participants' Perceptions of the Feasibility and Usability of DCP and AC assessed by a 5-point Likert Scale Questionnaire
The questionnaire is developed based on the Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) model. The scale ranges from 1 (Totally disagree) to 5 (Totally agree).
Measured: 6 months
Change from Baseline in Participant-Perceived Barriers to Hypertension Management at 6 Months
Participant-perceived barriers to hypertension management are assessed using a 5-point Likert scale questionnaire based on the model by Khatib et al (2014). The scale ranges from 1 (Totally disagree) to 5 (Totally agree).
Measured: Baseline and 6 months
Number of Hypertension-Related Healthcare Contacts During Follow-Up
The number of participant's healthcare contacts related to hypertension will be assessed after a 6-month follow-up using registry data of the Wellbeing Services County of Pirkanmaa. Healthcare contacts include all contacts (face-to-face and remote) with nurses and doctors at primary health care centers, as well as outpatient visits and inpatient hospital days in specialized healthcare.
Measured: From baseline to 6 months
Hypertension-Related Costs During Follow-Up
The costs will be assessed after a 6-month follow-up by multiplying participant's hypertension-related healthcare contacts with their unit costs obtained from the official price list of the Wellbeing Services County of Pirkanmaa. All costs will be reported in euros (€).
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start15 Oct 2026
- Primary completionMar 2028 (estimated)
- Study completionSep 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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wellbeing Services County of Pirkanmaa
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Responsible party
- Sponsor
- Investigators
- Tuomas Koskela, Professor, Chief Physician, Principal investigator, Faculty of Medicine and Health Technology, Tampere University, Finland. The Wellbeing Services County of Pirkanmaa, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812350
- Sponsor's protocol ID
- R25071
- Acronym
- DEPTH
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices).
Publications
McEvoy JW, McCarthy CP, Bruno RM, Brouwers S, Canavan MD, Ceconi C, Christodorescu RM, Daskalopoulou SS, Ferro CJ, Gerdts E, Hanssen H, Harris J, Lauder L, McManus RJ, Molloy GJ, Rahimi K, Regitz-Zagrosek V, Rossi GP, Sandset EC, Scheenaerts B, Staessen JA, Uchmanowicz I, Volterrani M, Touyz RM; ESC Scientific Document Group. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. 2024 Oct 7;45(38):3912-4018. doi: 10.1093/eurheartj/ehae178. No abstract available.
PubMed 39210715Khatib R, Schwalm JD, Yusuf S, Haynes RB, McKee M, Khan M, Nieuwlaat R. Patient and healthcare provider barriers to hypertension awareness, treatment and follow up: a systematic review and meta-analysis of qualitative and quantitative studies. PLoS One. 2014 Jan 15;9(1):e84238. doi: 10.1371/journal.pone.0084238. eCollection 2014.
PubMed 24454721
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Care Pathway and Asynchronous Communication for Primary Care Patients With Uncontrolled Hypertension: a Cluster-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07812350
- Acronym / sponsor ID
- DEPTH / R25071
- Conditions
- Hypertension
- Keywords
- Digital Health, Mobile Applications, Primary Health Care, Telemedicine, High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Wellbeing Services County of PirkanmaaUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 10 Sep 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 goal of this clinical trial is to learn if digital care pathway (DCP) and digital non-real-time messaging, in other words, asynchronous communication (AC) with nurse works to treat high blood pressure in adults in primary care. It will also learn if DCP and AC are good value for money. The main questions it aims to answer are:
- Does DCP and AC lower systolic blood pressure?
- Are DCP and AC good value for money in treating high blood pressure? Researchers will compare usual care plus DCP and usual care plus DCP with AC to usual care only to see if DCP and AC works to treat high blood pressure.
Participants will:
- Get usual care or usual care plus DCP or usual care plus DCP with AC for 6 months
- Visit the study nurse at the start of the trial and after 6 months for checkup and tests which include usual laboratory tests for high blood pressure
- Answer online survey questions and measure their blood pressure at home for 4 days at the start of the trial and after 6 months
Detailed description
The study will be conducted as a prospective, cluster-randomized controlled trial in six primary healthcare centres within the Wellbeing Services County of Pirkanmaa, Finland. Randomization will be performed at the healthcare centre level, with two centres allocated to each study arm. Because of the nature of the interventions, neither participants nor healthcare professionals can be blinded to treatment allocation.
Before the study begins, one induction session will be organised at all participating healthcare centres. This session will give healthcare professionals information about the study protocol and recommendations for hypertension management. In addition, professionals working at centres allocated to the intervention arms will receive training in the use of the digital care pathway and asynchronous communication.
One nurse from each participating centre will be appointed as a part-time study nurse. The study nurses will be responsible for participant recruitment, conducting baseline and follow-up visits, and promoting study awareness within their respective healthcare centres. During the study, participants will be monitored either by the study nurse or by other healthcare professional familiar with the participant. Hypertension management is optimised in accordance with the participant's home blood pressure readings.
Participants will be recruited for the study over a period of 6-12 months. Data will be collected at baseline and at the end of the 6 month follow-up. Data sources will include study nurse assessments during study visits, electronic health records and registers of the Wellbeing Services County of Pirkanmaa, the digital care pathway, and electronic questionnaires via the REDCap digital research platform.
Based on power calculations, assuming a statistical power of 80 percent and a two-sided significance level of 0.05, a minimum of 182 participants per study arm is required to detect a between-group difference of at least 5 mmHg in the change in systolic blood pressure during follow-up (SD of change in systolic blood pressure 17 mmHg). Considering cluster randomization and participant dropout during follow-up, the target sample size is 200 participants per study arm, resulting in a total sample size of 600 participants.
The results will be presented as means and standard deviations (SDs) for continuous variables, and frequencies and percentages for categorical variables. Between-group comparisons will be conducted using Student's t-test for normally distributed continuous variables, the Mann-Whitney U test for non-normally distributed continuous variables, and Pearson's chi-squared test or Fisher's exact test for categorical variables. The effects of the interventions on change in systolic blood pressure will be analysed using regression-based methods that account for the clustered study design, such as linear mixed-effects model. According to the intention-to-treat principle, all participants recruited to the study will be included in the primary analyses, regardless of whether they remained in the study for the entire follow-up period. A two-sided p-value of less than 0.05 will be considered statistically significant. All statistical analyses will be performed using IBM SPSS Statistics software.
The cost-effectiveness of the interventions will be assessed by calculating the incremental cost-effectiveness ratio (ICER), based on differences in both costs and effectiveness between the study arms. Costs will be assessed from the healthcare system perspective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual Care for hypertension |
| Digital Care Pathway | Experimental | Device: Digital care pathway for hypertensionUsual Care + Digital Care Pathway for 6 months |
| Digital Care Pathway and Asynchronous Communication | Experimental | Device: Digital care pathway for hypertension, Device: Asynchronous communication with nurseUsual Care + Digital Care Pathway with Asynchronous Communication with nurse for 6 months |
Who may qualify
- Ages
- 30 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a diagnosis of hypertension for at least 3 months
- an office blood pressure of ≥140/90 mmHg at baseline
- access to a smartphone and the ability to use strong electronic identification for application login
- ability to measure home blood pressure
- ability to take care of the personal medication
Key exclusion criteria (7 listed)
- unwillingness to participate in the study
- secondary hypertension or hypertensive crisis (office blood pressure >200/130 mmHg)
- atrial fibrillation
- stage 4 or 5 chronic kidney disease (eGFR <30 mL/min/1.73 m²)
- a life expectancy of less than 1 year
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 |
|---|---|---|
| Digital care pathway for hypertensionDigital care pathway for hypertension is a web-based and mobile application that includes goal setting and education material for hypertension, entering home blood pressure values, medication list and medication intake, blood pressure self-test and self-care survey, reminders on measuring values, upcoming appointments and self-care guidance, motivational messages and diary. | Device | Digital Care Pathway, Digital Care Pathway and Asynchronous Communication |
| Asynchronous communication with nurseAsynchronous communication means digital bidirectional non-real-time messaging between participant and nurse. It can be used with digital care pathway. | Device | Digital Care Pathway and Asynchronous Communication |
Primary outcome
Change from Baseline in the Office Systolic Blood Pressure Level at 6 Months
Time frame: Baseline and 6 months
Office systolic blood pressure is measured using a validated and calibrated blood pressure monitor in accordance with the 2024 European Society of Cardiology (ESC) guidelines. Three blood pressure measurements are taken by the study nurse during the office visit, and the average of the last two measurements is used as the participant's blood pressure level. If the blood pressure readings differ by more than 10 mmHg, additional measurements are taken.
11 secondary outcomes
Change from Baseline in the Home Systolic Blood Pressure Level at 6 Months
Time frame: Baseline and 6 months
Proportion of Participants with Controlled Blood Pressure at 6 months
Time frame: 6 months
Change from Baseline in the Cardiovascular Disease Risk at 6 Months assessed by FINRISKI risk calculator
Time frame: Baseline and 6 months
Change from Baseline in the Cardiovascular Disease Risk at 6 Months assessed by Systematic Coronary Risk Evaluation 2 (SCORE2) risk calculator
Time frame: Baseline and 6 months
Change from Baseline in Quality of Life at 6 Months
Time frame: Baseline and 6 months
Change from Baseline in Self-Care Preparedness Index at 6 Months
Time frame: Baseline and 6 months
Change from Baseline in Medication Adherence at 6 Months
Time frame: Baseline and 6 months
Participants' Perceptions of the Feasibility and Usability of DCP and AC assessed by a 5-point Likert Scale Questionnaire
Time frame: 6 months
Change from Baseline in Participant-Perceived Barriers to Hypertension Management at 6 Months
Time frame: Baseline and 6 months
Number of Hypertension-Related Healthcare Contacts During Follow-Up
Time frame: From baseline to 6 months
Hypertension-Related Costs During Follow-Up
Time frame: From baseline to 6 months
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 21 Oct 2026.
- Background: PubMed 39210715McEvoy JW, McCarthy CP, Bruno RM, Brouwers S, Canavan MD, Ceconi C, Christodorescu RM, Daskalopoulou SS, Ferro CJ, Gerdts E, Hanssen H, Harris J, Lauder L, McManus RJ, Molloy GJ, Rahimi K, Regitz-Zagrosek V, Rossi GP, Sandset EC, Scheenaerts B, Staessen JA, Uchmanowicz I, Volterrani M, Touyz RM; ESC Scientific Document Group. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. 2024 Oct 7;45(38):3912-4018. doi: 10.1093/eurheartj/ehae178. No abstract available.
- Background: PubMed 24454721Khatib R, Schwalm JD, Yusuf S, Haynes RB, McKee M, Khan M, Nieuwlaat R. Patient and healthcare provider barriers to hypertension awareness, treatment and follow up: a systematic review and meta-analysis of qualitative and quantitative studies. PLoS One. 2014 Jan 15;9(1):e84238. doi: 10.1371/journal.pone.0084238. eCollection 2014.
- Finnish Current Care Guidelines for HypertensionLink provided by the sponsor.
- Stride BP database for validated blood pressure monitorsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices).
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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.
Tuomas Koskela, Professor, Chief Physician principal investigator
Faculty of Medicine and Health Technology, Tampere University, Finland. The Wellbeing Services County of Pirkanmaa, Finland
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital care pathway for hypertension and Asynchronous communication with nurse in people with Hypertension, run by Wellbeing Services County of Pirkanmaa at 6 sites in Finland.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Teemu Ekola, MD (+358444863415, teemu.ekola@tuni.fi), 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 Office Systolic Blood Pressure Level at 6 Months (time frame: Baseline and 6 months). 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 NCT07812350, 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 21 Oct 2026.