Effectiveness and Cost-Effectiveness of a Digital Care Pathway and Asynchronous Communication for Patients With Hypertension

NCT07812350 | Not Yet Recruiting

• 1 other identifier: R25071
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 6

Brief 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. 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

Conditions

Hypertension

Keywords

Digital Health; Mobile Applications; Primary Health Care; Telemedicine; High Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months

Secondary Outcomes (11)

• Change from Baseline in the Home Systolic Blood Pressure Level at 6 Months

  Baseline and 6 months

• Proportion of Participants with Controlled Blood Pressure at 6 months

  6 months

• Change from Baseline in the Cardiovascular Disease Risk at 6 Months assessed by FINRISKI risk calculator

  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

  Baseline and 6 months

• Change from Baseline in Quality of Life at 6 Months

  Baseline and 6 months

Study Arms (3)

Control

NO INTERVENTION

Usual Care for hypertension

Digital Care Pathway

EXPERIMENTAL

Usual Care + Digital Care Pathway for 6 months

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

Device: Digital care pathway for hypertension; Device: Asynchronous communication with nurse

Interventions

Digital care pathway for hypertension DEVICE

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.

Digital Care Pathway; Digital Care Pathway and Asynchronous Communication

Asynchronous communication with nurse DEVICE

Asynchronous communication means digital bidirectional non-real-time messaging between participant and nurse. It can be used with digital care pathway.

Digital Care Pathway and Asynchronous Communication

Eligibility Criteria

• Age: 30 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wellbeing Services County of Pirkanmaa: lead
• Tampere University: collaborator

Study Sites (6)

Akaa health and social services centre, The Wellbeing Services County of Pirkanmaa

Akaa, Pirkanmaa, Finland

Location

Sastamala health and social services centre, The Wellbeing Services County of Pirkanmaa

Sastamala, Pirkanmaa, Finland

Location

Hatanpää health and social services centre, The Wellbeing Services County of Pirkanmaa

Tampere, Pirkanmaa, Finland

Location

Hervanta health and social services centre, The Wellbeing Services County of Pirkanmaa

Tampere, Pirkanmaa, Finland

Location

Linnainmaa health and social services centre, The Wellbeing Services County of Pirkanmaa

Tampere, Pirkanmaa, Finland

Location

Valkeakoski health and social services centre, The Wellbeing Services County of Pirkanmaa

Valkeakoski, Pirkanmaa, Finland

Location

Related Publications (2)

• 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.

  PMID: 39210715 BACKGROUND

• Khatib 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.

  PMID: 24454721 BACKGROUND

Related Links

• Finnish Current Care Guidelines for Hypertension
• Stride BP database for validated blood pressure monitors

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Tuomas Koskela, Professor, Chief Physician

  Faculty of Medicine and Health Technology, Tampere University, Finland. The Wellbeing Services County of Pirkanmaa, Finland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teemu Ekola, MD

CONTACT

+358444863415; teemu.ekola@tuni.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 10, 2026
• Study Start: September 28, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

FI (6)