Primary Care ProviderNCT06904469
Ostrobothnia Digital Clinic Experiment
A study testing Access to a digital clinic in people with Primary Care Provider, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Primary Care Provider
- What is being tested?
- Access to a digital clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170,306 participants
- Where
- 1 siteFinland
- Study dates
- 15 Apr 2025to 14 Jan 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Resides in the city of Kristiinankaupunki OR resides in a household defined as institutionalized care
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Primary Care Provider
- Being tested
- Access to a digital clinic
- Keywords
- digital healthcare, telemedicine, digital clinic, primary care, healthcare utilization, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to a digital clinicOther
This intervention grants access to a digital clinic that provides chat-based primary care consultations via phone application and website.
| Study group | Role | What they receive |
|---|---|---|
| Access to a digital clinic | Experimental | Access to a digital clinic, which offers assessments, diagnoses, follow-up care recommendations, and prescriptions Receives: Other: Access to a digital clinic |
| No access to a digital clinic (treatment as usual) | No intervention | Health care as usual without access rights to a digital clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of in-person visits in public primary care (Y1.1)
This outcome includes in-person visits to nurses and physicians in traditional public primary care clinics.
Measured: From the digital clinic launch to the end of treatment at 9 months
Secondary outcomes (2)
The number of other contacts with traditional public primary care (Y1.2)
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.
Measured: From the digital clinic launch to the end of treatment at 9 months
The number of public digital clinic contacts (D.1).
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.
Measured: From the digital clinic launch to the end of treatment at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start15 Apr 2025
- Primary completion14 Jan 2026 (estimated)
- Study completion14 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Care ProviderStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized controlled trials, households as clusters
- Masking
- None (open label)
- Enrolment
- 170,306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Aalto University, University of Turku
- Responsible party
- Principal investigator, Lauri Sääksvuori, Finnish Institute for Health and Welfare
- Investigators
- Mika T Kortelainen, PhD, Study director, University of Turku and Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904469
- Sponsor's protocol ID
- THL/5935/6.02.01/2024
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ostrobothnia Digital Clinic Experiment
- ClinicalTrials.gov ID
- NCT06904469
- Acronym / sponsor ID
- THL/5935/6.02.01/2024
- Conditions
- Primary Care Provider
- Keywords
- digital healthcare, telemedicine, digital clinic, primary care, healthcare utilization, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 170,306 participants (estimated)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Aalto University, University of Turku
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 14 Jan 2026 (estimated)
- Study completion
- 14 Jan 2026 (estimated)
- First posted
- 1 Apr 2025 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized controlled trials, households as clusters
| Arm | Type | Receives |
|---|---|---|
| Access to a digital clinic | Experimental | Other: Access to a digital clinicAccess to a digital clinic, which offers assessments, diagnoses, follow-up care recommendations, and prescriptions |
| No access to a digital clinic (treatment as usual) | No intervention | –Health care as usual without access rights to a digital clinic |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- Resides in the city of Kristiinankaupunki OR resides in a household defined as institutionalized care
- 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
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 |
|---|---|---|
| Access to a digital clinicThis intervention grants access to a digital clinic that provides chat-based primary care consultations via phone application and website. | Other | Access to a digital clinic |
Primary outcome
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.
2 secondary outcomes
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
The number of public digital clinic contacts (D.1).
Time frame: From the digital clinic launch to the end of treatment at 9 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 20 Aug 2025.
- Replication codes (GitHub)Link provided by the sponsor.
- Pre-analysis plan as of March 28, 2025Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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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. This study is not recruiting at the moment.
Mika T Kortelainen, PhD study director
University of Turku and Finnish Institute for Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to a digital clinic in people with Primary Care Provider, run by Finnish Institute for Health and Welfare at 1 site 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 1 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2025; AzTrials last refreshed its copy on 1 Nov 2026.