Ostrobothnia Digital Clinic Experiment

August 18, 2025 updated by: Lauri Sääksvuori, Finnish Institute for Health and Welfare
This randomized controlled trial (RCT) examines the impacts of a publicly provided digital clinic that offers digital primary care services to consumers. This intervention grants access to a public digital clinic that provides chat-based primary care consultations via a mobile phone application and website, including care needs assessment, diagnoses, follow-up care recommendations, and prescriptions. The digital clinic supplements traditional public primary care services, including in-person visits and phone consultations. The trial takes place in Ostrobothnia, Finland, a healthcare district serving a population of 178,000 residents. The investigators will randomize access to the digital clinic at the household level, providing access to 50% of the households. By doing so, the investigators aim to evaluate whether digital services can substitute for, complement, or increase the utilization of traditional primary care, particularly in-person visits or calls to traditional clinics. At the end of the nine-month trial, access to the digital clinic will be expanded to the entire population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170306

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Finland
      • Vaasa, Finland
        • Wellbeing Services County of Ostrobothnia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria for the intervention:

  • All residents alive and residing in the region of Ostrobothnia (Finland) on March 14, 2015, AND permanent address observed in the Finnish Population Information System

Exclusion Criteria for the intervention:

  • Resides in the city of Kristiinankaupunki OR resides in a household defined as institutionalized care

Exclusion Criteria for the analysis sample:

  • The inclusion and exclusion criteria mentioned above AND:
  • If an individual from the target population, extracted from the Population Information System, is not observed in Statistics Finland datasets, which is defined as not having a municipality of residence (missing data) at the end of 2024, the investigators will not use that individual in the study population in the analyses because the data do not include have covariates for the individual.
  • Age 71 and above

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Access to a digital clinic
Access to a digital clinic, which offers assessments, diagnoses, follow-up care recommendations, and prescriptions
Other: Access to a digital clinic
This intervention grants access to a digital clinic that provides chat-based primary care consultations via phone application and website.
No Intervention: No access to a digital clinic (treatment as usual)
Health care as usual without access rights to a digital clinic

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The number of in-person visits in public primary care (Y1.1)
Time Frame: From the digital clinic launch to the end of treatment at 9 months
This outcome includes in-person visits to nurses and physicians in traditional public primary care clinics.
From the digital clinic launch to the end of treatment at 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number of other contacts with traditional public primary care (Y1.2)
Time Frame: From the digital clinic launch to the end of treatment at 9 months
This outcome includes care needs assessments, remote appointments to nurses and physicians, and professional-to-professional interactions between nurses and physicians in traditional public primary care clinics.
From the digital clinic launch to the end of treatment at 9 months
The number of public digital clinic contacts (D.1).
Time Frame: From the digital clinic launch to the end of treatment at 9 months
This outcome includes care needs assessments, remote appointments to nurses and physicians (via chat and video), and professional-to-professional interactions between nurses and physicians in digital public primary care clinics.
From the digital clinic launch to the end of treatment at 9 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The total number of public primary care contacts (Y1.3)
Time Frame: From the digital clinic launch to the end of treatment at 9 months
This outcome includes in-person visits to nurses and physicians, care needs assessments, remote appointments to nurses and physicians, and professional-to-professional interactions between nurses and physicians in digital and traditional public primary care clinics.
From the digital clinic launch to the end of treatment at 9 months
Presence or absence of public digital clinic contacts during the follow-up (yes/no) (D.2).
Time Frame: From the digital clinic launch to the end of treatment at 9 months

This outcome includes care needs assessments, remote appointments to nurses and physicians (via chat and video), and professional-to-professional interactions between nurses and physicians in digital public primary care clinics.

This outcome is 1 if the person has at least one contact with the public digital clinic during follow-up and 0 if the person has no contact during follow-up.
From the digital clinic launch to the end of treatment at 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Finnish Institute for Health and Welfare

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Turku
Aalto University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mika T Kortelainen, PhD, University of Turku and Finnish Institute for Health and Welfare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • THL/5935/6.02.01/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The dataset containing individual-level health data and demographic data is regulated under the Act on the Secondary Use of Health and Social Data (552/2019) and cannot be made readily available for the purpose of direct replication. However, access to the data can be obtained by sending requests to the Finnish Social and Health Data Permit Authority, Findata, and to Statistics Finland. The investigators commit to publishing all statistical code and other details of the computations that are sufficient to permit the validation of empirical work. The investigators commit to storing the treatment assignment code and data for future use, allowing interested researchers to construct the full dataset required for further research utilizing the original treatment assignment.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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