NCT03213327

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 15, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

July 10, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

2.1 years

First QC Date

June 15, 2017

Last Update Submit

June 21, 2020

Conditions

Mental Health Disorder

Keywords

mental healthassessmenthealth promotioncase managementhealth insurance

Outcome Measures

Primary Outcomes (3)

  • Psychological distress

    The psychological distress is assessed by the Brief Symptom Inventory (BSI; Derogatis \& Melisaratos, 1983)

    0 week (first assessment)

  • Work-related sense of coherence

    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

    This aspect is measure by the General Self-Efficacy Scale (GSE; Damásio et al., 2016)

    0 weeks

Secondary Outcomes (1)

  • Effectiveness of health-promoting advices

    12 weeks after the first assessment

Study Arms (1)

Case management

OTHER

Case management program Utilization of the StayOk web application

Device: StayOk web application

Interventions

StayOk web applicationDEVICE

Patients fill in the questionnaires of the web application and receive an analyzed profile of their psychosocial condition and health-promoting advices

Case management

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • at 16 years of age
  • mild to moderate psychological distress

You may not qualify if:

  • serious cognitive impairment due to dementia or cerebrovascular insult
  • Insufficient knowledge of one of the following languages: German, French, Italian or English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsana

Zurich, Switzerland

Location

Related Publications (3)

  • Derogatis LR, Melisaratos N. The Brief Symptom Inventory: an introductory report. Psychol Med. 1983 Aug;13(3):595-605.

    PMID: 6622612BACKGROUND

  • 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/

    PMID: 28590629BACKGROUND

  • 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.

    PMID: 27225231BACKGROUND

Related Links

MeSH Terms

Conditions

Mental DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Agnes von Wyl, Prof

    Zurich University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Patients are examined at two time points: baseline and 12 weeks after the Intervention. The Intervention consists of health-promoting advices provided by the software algorithm. The effect of this intervention is evaluated 12 weeks after.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. phil.

Study Record Dates

First Submitted

June 15, 2017

First Posted

July 11, 2017

Study Start

July 10, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

June 23, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)