- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04677270
Evaluation of Two Versions of a Digital Problem Solving Tool for the General Public Specific for the COVID-19 Pandemic (COVIDPROBLEM)
December 18, 2020 updated by: Martin Kraepelien, Karolinska Institutet
A digital problem solving tool was tailored to people in the general public with practical or emotional problems during COVID-19.
Content analysis were used to account for the types of problems participants used the tool to solve.
Participants were randomized to one of two versions of the problem solving tool, a simple and a more advanced graphical interface.
These versions were compared on participant-rated usability, credibility and the level of actual interaction with the tool.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
397
Phase
- 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 Locations
-
-
-
Stockholm, Sweden
- Centrum för Psykiatriforskning
-
-
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
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- can use the Swedish language
- access to, and knowledge how to use, a digital internet-capable device
Exclusion Criteria:
- under 16 years
- no practical or emotional problems during pandemic
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Traditional interface
Digital problem solving tool with a simple textbased graphical interface
|
Digital problem solving tool - adapted for practical and emotional problems during the COVID-19 pandemic
|
|
Experimental: Advanced interface
Digital problem solving tool with an advanced graphical interface and automatic functions
|
Digital problem solving tool - adapted for practical and emotional problems during the COVID-19 pandemic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System Usability Scale
Time Frame: immediately after the intervention
|
Self-rated assessment of usability, higher score is better
|
immediately after the intervention
|
|
Treatment Credibility Scale
Time Frame: immediately after the intervention
|
Self-rated assessment of treatment credibility, higher score is better
|
immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Use of intervention
Time Frame: immediately after the intervention
|
How much has the participant interacted with the problem solving tool.
|
immediately after the intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Problem categories
Time Frame: immediately after the intervention
|
What categories of problems do participants solve with the problem solving tool.
|
immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Martin Kraepelien, PhD, Karolinska Institutet
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.
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)
August 31, 2020
Primary Completion (Actual)
November 30, 2020
Study Completion (Actual)
November 30, 2020
Study Registration Dates
First Submitted
December 18, 2020
First Submitted That Met QC Criteria
December 18, 2020
First Posted (Actual)
December 21, 2020
Study Record Updates
Last Update Posted (Actual)
December 21, 2020
Last Update Submitted That Met QC Criteria
December 18, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVIDPROBLEM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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