NCT06904469

Brief 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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170,306

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2026

Completed
Last Updated

August 20, 2025

Status Verified

March 1, 2025

Enrollment Period

9 months

First QC Date

March 18, 2025

Last Update Submit

August 18, 2025

Conditions

Keywords

digital healthcaretelemedicinedigital clinicprimary carehealthcare utilizationrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    From the digital clinic launch to the end of treatment at 9 months

  • The number of public digital clinic contacts (D.1).

    From the digital clinic launch to the end of treatment at 9 months

Other Outcomes (2)

  • The total number of public primary care contacts (Y1.3)

    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).

    From the digital clinic launch to the end of treatment at 9 months

Study Arms (2)

Access to a digital clinic

EXPERIMENTAL

Access to a digital clinic, which offers assessments, diagnoses, follow-up care recommendations, and prescriptions

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

Interventions

This intervention grants access to a digital clinic that provides chat-based primary care consultations via phone application and website.

Access to a digital clinic

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wellbeing Services County of Ostrobothnia

Vaasa, Finland

Location

Related Links

Study Officials

  • Mika T Kortelainen, PhD

    University of Turku and Finnish Institute for Health and Welfare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster-randomized controlled trials, households as clusters
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 18, 2025

First Posted

April 1, 2025

Study Start

April 15, 2025

Primary Completion

January 14, 2026

Study Completion

January 14, 2026

Last Updated

August 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

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.

Locations