- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02445950
With-Me - Technology-Aided Phone Coaching for Occupational Health Study
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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.
|
Aktivní komparátor: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Time used for coaching
Časové okno: 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
Časové okno: 6 months
|
Measured by the Työoptimi occupational health questionnaire.
This is used to evaluate the effectiveness of the coaching.
|
6 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Customer satisfaction for coaching
Časové okno: 6 months
|
Measured by ad hoc questionnaires.
|
6 months
|
Occupational health
Časové okno: 6 months
|
Measured by Työoptimi occupational health questionnaire.
|
6 months
|
Satisfaction to life situation
Časové okno: 6 months
|
Measured by scale from 1 to 5.
|
6 months
|
Self-esteem
Časové okno: 6 months
|
Measured by 10-item Rosenberg's Self-Esteem Scale.
|
6 months
|
Cognitive fusion
Časové okno: 6 months
|
Measured by 7-item Cognitive Fusion Questionnaire
|
6 months
|
Perceived stress
Časové okno: 6 months
|
Measured by a single-item stress scale.
|
6 months
|
Satisfaction to a relationship
Časové okno: 6 months
|
The scale is modified from The Family Federation of Finland's quality test of a relationship.
|
6 months
|
Activeness in conducting tasks
Časové okno: 6 months
|
Self-assessment measured via phone interviews and questionnaires.
|
6 months
|
Carefulness in conducting tasks
Časové okno: 6 months
|
Self-assessment measured via phone interviews and questionnaires.
|
6 months
|
Readiness to change
Časové okno: 6 months
|
Readiness to change scale measured by questionnaire based on Transtheoretical Model (Stages of Change).
|
6 months
|
Lifestyle
Časové okno: 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
Časové okno: 1 month
|
Data from the profiling database.
|
1 month
|
Perceived Accuracy of the profiling tool
Časové okno: 1 month
|
Assessed by the coaches via questionnaires.
|
1 month
|
Perceived ease of use
Časové okno: 6 months
|
Measured by questionnaires to customers, questionnaires and interview to coaches.
|
6 months
|
Perceived usefulness
Časové okno: 6 months
|
Measured by the questionnaires to customers, questionnaires and interview to coaches.
|
6 months
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Hannu Nieminen, PhD, Technical University of Denmark
- Vrchní vyšetřovatel: Jouni Kaartinen, DSc, VTT Technical Research Centre of Finland Ltd
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 332885 With-Me-Occ
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Psychický stres
-
VA Office of Research and DevelopmentVA St. Louis Health Care SystemUkončenoVeteráni podle St. Louis VAMC Stress TesSpojené státy