- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03213327
StayOK - an Innovative Measuring Instrument for the Early Identification and Treatment of Psychosocial Risks (StayOK)
June 21, 2020 updated by: Aureliano Crameri, Zurich University of Applied Sciences
The validity and the sensitivity of different measures implemented in the web application StayOk are investigated.
The measures are used primarily for the assessment and the early identification of psychosocial risks.
Secondarily, the results of the assessment are applied to generate health-promoting advices for the user of the web application.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
174
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
-
-
-
Zürich, Switzerland
- Helsana
-
-
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 to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- at 16 years of age
- mild to moderate psychological distress
Exclusion Criteria:
- serious cognitive impairment due to dementia or cerebrovascular insult
- Insufficient knowledge of one of the following languages: German, French, Italian or English
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Case management
Case management program Utilization of the StayOk web application
|
Patients fill in the questionnaires of the web application and receive an analyzed profile of their psychosocial condition and health-promoting advices
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological distress
Time Frame: 0 week (first assessment)
|
The psychological distress is assessed by the Brief Symptom Inventory (BSI; Derogatis & Melisaratos, 1983)
|
0 week (first assessment)
|
|
Work-related sense of coherence
Time Frame: 0 weeks
|
The work-related sense of coherence is assessed by the Work Sense of Coherence (W-SoC 9; Jenny et al., 2016)
|
0 weeks
|
|
Perceived self-efficacy
Time Frame: 0 weeks
|
This aspect is measure by the General Self-Efficacy Scale (GSE; Damásio et al., 2016)
|
0 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effectiveness of health-promoting advices
Time Frame: 12 weeks after the first assessment
|
The effectiveness of the advices generated by the software is assessed by means of a self-developed questionnaire: Participants are inquired as to (1) whether they put in practice the advices and (2) how they evaluate the benefit of the applied advices and the consequent satisfaction.
|
12 weeks after the first assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Agnes von Wyl, Prof, Zurich University of Applied Sciences
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.
General Publications
- Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.
- Jenny GJ, Bauer GF, Vinje HF, Vogt K, Torp S. The Application of Salutogenesis to Work. 2016 Sep 3. In: Mittelmark MB, Sagy S, Eriksson M, Bauer GF, Pelikan JM, Lindstrom B, Espnes GA, editors. The Handbook of Salutogenesis [Internet]. Cham (CH): Springer; 2017. Chapter 20. Available from http://www.ncbi.nlm.nih.gov/books/NBK435821/
- Damasio BF, Valentini F, Nunes-Rodriguez SI, Kliem S, Koller SH, Hinz A, Brahler E, Finck C, Zenger M. Is the General Self-Efficacy Scale a Reliable Measure to be used in Cross-Cultural Studies? Results from Brazil, Germany and Colombia. Span J Psychol. 2016 May 26;19:E29. doi: 10.1017/sjp.2016.30.
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)
July 10, 2017
Primary Completion (Actual)
July 31, 2019
Study Completion (Actual)
July 31, 2019
Study Registration Dates
First Submitted
June 15, 2017
First Submitted That Met QC Criteria
July 7, 2017
First Posted (Actual)
July 11, 2017
Study Record Updates
Last Update Posted (Actual)
June 23, 2020
Last Update Submitted That Met QC Criteria
June 21, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BASEC-Nr. 2016-00879
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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