- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02445950
With-Me - Technology-Aided Phone Coaching for Occupational Health Study
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The study focuses on mental well-being. The both interventions include intensive and independent phase.
The intensive phase lasts 13 weeks. In the intensive phase, goals for the coaching are defined. Coach calls the customer every two weeks and they discuss about the actions that took place in the previous two weeks and what they need to do in the next two weeks. In the technology-aided arm, customers get and analysis of their change needs via digital tool. Based on the change needs they receive task/goal suggestions from which they need to choose 3. Coach is able to see these choices and exploits it in the coaching. The selected behavioral activation interventions are delivered to customer utilizing a web-based coaching tool.
The independent phase lasts 13 weeks. In the independent phase, technology-aided group is coached via the digital tool. The phone counseling group gets 3 phone calls.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- At least a bachelor level degree
- Age over 18 years
- Decreased psycho-physic state (own assessment)
- Is in a relationship
- Motivated to enhance own well-being and willing to change lifestyle, to do exercises related on mental well-being and relationship
- Willing to use technological wellness coaching tools, familiarity with technology
Exclusion Criteria:
- Work includes night shifts
- Acute health conditions or serious diseases
- Chronical pain affecting functionality
- Long period(s) of absence from work during the coaching period (e.g. long vacation, alternation leave, parental leave, pension)
- Participation in some other study
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Technology-aided counseling
Customers receive intervention via technology-aided phone wellness counseling.
The intensive phase lasts 13 weeks and includes 5 phone calls.
The customers are able to view their change change needs and choose tasks/goals for the coaching.
The independent phase lasts 13 weeks and coaching is done via a digital tool.
|
The intervention provides phone wellness counselling with the help of web-based interventions, digital profiling and suggestion tool in occupational health.
|
|
Aktiv komparator: Traditional counseling
Customers receive intervention via traditional phone wellness counseling.
The intensive phase lasts 13 weeks and includes 5 phone calls.
Change needs and goals are set during the phone calls.
The independent phase lasts 13 weeks and includes 3 phone calls.
|
The intervention provides phone wellness counseling in occupational health.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time used for coaching
Tidsramme: 6 months
|
Measured by the coaches' working time dedicated to coaching from manual logs and Movendos log.
This is used to evaluate the cost of coaching.
|
6 months
|
|
Psychological wellbeing
Tidsramme: 6 months
|
Measured by the Työoptimi occupational health questionnaire.
This is used to evaluate the effectiveness of the coaching.
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Customer satisfaction for coaching
Tidsramme: 6 months
|
Measured by ad hoc questionnaires.
|
6 months
|
|
Occupational health
Tidsramme: 6 months
|
Measured by Työoptimi occupational health questionnaire.
|
6 months
|
|
Satisfaction to life situation
Tidsramme: 6 months
|
Measured by scale from 1 to 5.
|
6 months
|
|
Self-esteem
Tidsramme: 6 months
|
Measured by 10-item Rosenberg's Self-Esteem Scale.
|
6 months
|
|
Cognitive fusion
Tidsramme: 6 months
|
Measured by 7-item Cognitive Fusion Questionnaire
|
6 months
|
|
Perceived stress
Tidsramme: 6 months
|
Measured by a single-item stress scale.
|
6 months
|
|
Satisfaction to a relationship
Tidsramme: 6 months
|
The scale is modified from The Family Federation of Finland's quality test of a relationship.
|
6 months
|
|
Activeness in conducting tasks
Tidsramme: 6 months
|
Self-assessment measured via phone interviews and questionnaires.
|
6 months
|
|
Carefulness in conducting tasks
Tidsramme: 6 months
|
Self-assessment measured via phone interviews and questionnaires.
|
6 months
|
|
Readiness to change
Tidsramme: 6 months
|
Readiness to change scale measured by questionnaire based on Transtheoretical Model (Stages of Change).
|
6 months
|
|
Lifestyle
Tidsramme: 6 months
|
Evaluated by ad hoc questionnaire on amount of sleep, alcohol consumption and smoking, and eating habits.
|
6 months
|
|
Number of the changes made to the profile
Tidsramme: 1 month
|
Data from the profiling database.
|
1 month
|
|
Perceived Accuracy of the profiling tool
Tidsramme: 1 month
|
Assessed by the coaches via questionnaires.
|
1 month
|
|
Perceived ease of use
Tidsramme: 6 months
|
Measured by questionnaires to customers, questionnaires and interview to coaches.
|
6 months
|
|
Perceived usefulness
Tidsramme: 6 months
|
Measured by the questionnaires to customers, questionnaires and interview to coaches.
|
6 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Hannu Nieminen, PhD, Technical University of Denmark
- Hovedetterforsker: Jouni Kaartinen, DSc, VTT Technical Research Centre of Finland Ltd
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 332885 With-Me-Occ
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