- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06904469
Ostrobothnia Digital Clinic Experiment
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vaasa, Finland
- Wellbeing Services County of Ostrobothnia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Access to a digital clinic
Access to a digital clinic, which offers assessments, diagnoses, follow-up care recommendations, and prescriptions
|
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
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
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
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
Investigators
- Study Director: Mika T Kortelainen, PhD, University of Turku and Finnish Institute for Health and Welfare
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- THL/5935/6.02.01/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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