An interventional study of Digital care pathway for hypertension and Asynchronous communication with nurse in Hypertension, sponsored by Wellbeing Services County of Pirkanmaa. Recruiting at 6 sites in Finland. Open to participants aged 30 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Wellbeing Services County of Pirkanmaa · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 600 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Wellbeing Services County of Pirkanmaa is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Usual Care for hypertension
Usual Care + Digital Care Pathway for 6 months
Device: Digital care pathway for hypertension
Usual Care + Digital Care Pathway with Asynchronous Communication with nurse for 6 months
Device: Digital care pathway for hypertension · Device: Asynchronous communication with nurse
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 means digital bidirectional non-real-time messaging between participant and nurse. It can be used with digital care pathway.
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.
Time frame: Baseline and 6 months
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.
Time frame: 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
Time frame: 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.
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
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
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
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).
Time frame: 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).
Time frame: 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.
Time frame: 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 (€).
Time frame: From baseline to 6 months
Plan to share: Yes — Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices).
Supporting information: Study protocol
Time frame: Beginning 3 months and ending 5 years after the publication of results.
Access criteria: Upon reasonable request for researchers in the EU region.
Started Oct 2026 (actual). Primary completion is estimated for Mar 2028, 17 months after the start.
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 17 months is below that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 21, 2026: start Sep 2026 → Oct 2026, primary completion Feb 2028 → Mar 2028 and completion Aug 2028 → Sep 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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 ↗
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Wellbeing Services County of Pirkanmaa