- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02445950
With-Me - Technology-Aided Phone Coaching for Occupational Health Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time used for coaching
Time Frame: 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
Time Frame: 6 months
|
Measured by the Työoptimi occupational health questionnaire.
This is used to evaluate the effectiveness of the coaching.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Customer satisfaction for coaching
Time Frame: 6 months
|
Measured by ad hoc questionnaires.
|
6 months
|
Occupational health
Time Frame: 6 months
|
Measured by Työoptimi occupational health questionnaire.
|
6 months
|
Satisfaction to life situation
Time Frame: 6 months
|
Measured by scale from 1 to 5.
|
6 months
|
Self-esteem
Time Frame: 6 months
|
Measured by 10-item Rosenberg's Self-Esteem Scale.
|
6 months
|
Cognitive fusion
Time Frame: 6 months
|
Measured by 7-item Cognitive Fusion Questionnaire
|
6 months
|
Perceived stress
Time Frame: 6 months
|
Measured by a single-item stress scale.
|
6 months
|
Satisfaction to a relationship
Time Frame: 6 months
|
The scale is modified from The Family Federation of Finland's quality test of a relationship.
|
6 months
|
Activeness in conducting tasks
Time Frame: 6 months
|
Self-assessment measured via phone interviews and questionnaires.
|
6 months
|
Carefulness in conducting tasks
Time Frame: 6 months
|
Self-assessment measured via phone interviews and questionnaires.
|
6 months
|
Readiness to change
Time Frame: 6 months
|
Readiness to change scale measured by questionnaire based on Transtheoretical Model (Stages of Change).
|
6 months
|
Lifestyle
Time Frame: 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
Time Frame: 1 month
|
Data from the profiling database.
|
1 month
|
Perceived Accuracy of the profiling tool
Time Frame: 1 month
|
Assessed by the coaches via questionnaires.
|
1 month
|
Perceived ease of use
Time Frame: 6 months
|
Measured by questionnaires to customers, questionnaires and interview to coaches.
|
6 months
|
Perceived usefulness
Time Frame: 6 months
|
Measured by the questionnaires to customers, questionnaires and interview to coaches.
|
6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hannu Nieminen, PhD, Technical University of Denmark
- Principal Investigator: Jouni Kaartinen, DSc, VTT Technical Research Centre of Finland Ltd
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 332885 With-Me-Occ
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