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With-Me - Technology-Aided Phone Coaching for Occupational Health Study

Primary Purpose

Psychological Stress

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Technology-aided phone wellness counselling
Phone wellness counselling
Sponsored by
VTT Technical Research Centre of Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Psychological Stress focused on measuring Coaching, Well-being, Digital Health, Profiling, Customer Satisfaction, User Experience, Occupational Health, Lifestyle, Psychological Stress, Cost-Effectiveness, Guideline Adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Technology-aided counseling

    Traditional counseling

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Time used for coaching
    Measured by the coaches' working time dedicated to coaching from manual logs and Movendos log. This is used to evaluate the cost of coaching.
    Psychological wellbeing
    Measured by the Työoptimi occupational health questionnaire. This is used to evaluate the effectiveness of the coaching.

    Secondary Outcome Measures

    Customer satisfaction for coaching
    Measured by ad hoc questionnaires.
    Occupational health
    Measured by Työoptimi occupational health questionnaire.
    Satisfaction to life situation
    Measured by scale from 1 to 5.
    Self-esteem
    Measured by 10-item Rosenberg's Self-Esteem Scale.
    Cognitive fusion
    Measured by 7-item Cognitive Fusion Questionnaire
    Perceived stress
    Measured by a single-item stress scale.
    Satisfaction to a relationship
    The scale is modified from The Family Federation of Finland's quality test of a relationship.
    Activeness in conducting tasks
    Self-assessment measured via phone interviews and questionnaires.
    Carefulness in conducting tasks
    Self-assessment measured via phone interviews and questionnaires.
    Readiness to change
    Readiness to change scale measured by questionnaire based on Transtheoretical Model (Stages of Change).
    Lifestyle
    Evaluated by ad hoc questionnaire on amount of sleep, alcohol consumption and smoking, and eating habits.
    Number of the changes made to the profile
    Data from the profiling database.
    Perceived Accuracy of the profiling tool
    Assessed by the coaches via questionnaires.
    Perceived ease of use
    Measured by questionnaires to customers, questionnaires and interview to coaches.
    Perceived usefulness
    Measured by the questionnaires to customers, questionnaires and interview to coaches.

    Full Information

    First Posted
    May 6, 2015
    Last Updated
    April 25, 2016
    Sponsor
    VTT Technical Research Centre of Finland
    Collaborators
    Firstbeat Technologies Ltd., Mawell Care Ltd, Mawell Ltd, Oulun Työterveys, Technical University of Denmark
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02445950
    Brief Title
    With-Me - Technology-Aided Phone Coaching for Occupational Health Study
    Official Title
    With-Me - Technology-Aided Phone Coaching for Occupational Health Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    VTT Technical Research Centre of Finland
    Collaborators
    Firstbeat Technologies Ltd., Mawell Care Ltd, Mawell Ltd, Oulun Työterveys, Technical University of Denmark

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to examine whether the technology (web-based coaching, profiling and suggestion tool) brings added value to the traditional phone coaching in occupational health context. The interventions are phone counseling interventions. The other intervention exploits additionally a specific web-based coaching, profiling and suggestion tool.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychological Stress
    Keywords
    Coaching, Well-being, Digital Health, Profiling, Customer Satisfaction, User Experience, Occupational Health, Lifestyle, Psychological Stress, Cost-Effectiveness, Guideline Adherence

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Technology-aided counseling
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Traditional counseling
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Technology-aided phone wellness counselling
    Intervention Description
    The intervention provides phone wellness counselling with the help of web-based interventions, digital profiling and suggestion tool in occupational health.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Phone wellness counselling
    Intervention Description
    The intervention provides phone wellness counseling in occupational health.
    Primary Outcome Measure Information:
    Title
    Time used for coaching
    Description
    Measured by the coaches' working time dedicated to coaching from manual logs and Movendos log. This is used to evaluate the cost of coaching.
    Time Frame
    6 months
    Title
    Psychological wellbeing
    Description
    Measured by the Työoptimi occupational health questionnaire. This is used to evaluate the effectiveness of the coaching.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Customer satisfaction for coaching
    Description
    Measured by ad hoc questionnaires.
    Time Frame
    6 months
    Title
    Occupational health
    Description
    Measured by Työoptimi occupational health questionnaire.
    Time Frame
    6 months
    Title
    Satisfaction to life situation
    Description
    Measured by scale from 1 to 5.
    Time Frame
    6 months
    Title
    Self-esteem
    Description
    Measured by 10-item Rosenberg's Self-Esteem Scale.
    Time Frame
    6 months
    Title
    Cognitive fusion
    Description
    Measured by 7-item Cognitive Fusion Questionnaire
    Time Frame
    6 months
    Title
    Perceived stress
    Description
    Measured by a single-item stress scale.
    Time Frame
    6 months
    Title
    Satisfaction to a relationship
    Description
    The scale is modified from The Family Federation of Finland's quality test of a relationship.
    Time Frame
    6 months
    Title
    Activeness in conducting tasks
    Description
    Self-assessment measured via phone interviews and questionnaires.
    Time Frame
    6 months
    Title
    Carefulness in conducting tasks
    Description
    Self-assessment measured via phone interviews and questionnaires.
    Time Frame
    6 months
    Title
    Readiness to change
    Description
    Readiness to change scale measured by questionnaire based on Transtheoretical Model (Stages of Change).
    Time Frame
    6 months
    Title
    Lifestyle
    Description
    Evaluated by ad hoc questionnaire on amount of sleep, alcohol consumption and smoking, and eating habits.
    Time Frame
    6 months
    Title
    Number of the changes made to the profile
    Description
    Data from the profiling database.
    Time Frame
    1 month
    Title
    Perceived Accuracy of the profiling tool
    Description
    Assessed by the coaches via questionnaires.
    Time Frame
    1 month
    Title
    Perceived ease of use
    Description
    Measured by questionnaires to customers, questionnaires and interview to coaches.
    Time Frame
    6 months
    Title
    Perceived usefulness
    Description
    Measured by the questionnaires to customers, questionnaires and interview to coaches.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hannu Nieminen, PhD
    Organizational Affiliation
    Technical University of Denmark
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jouni Kaartinen, DSc
    Organizational Affiliation
    VTT Technical Research Centre of Finland Ltd
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35830233
    Citation
    Muuraiskangas ST, Honka AM, Junno UM, Nieminen HO, Kaartinen JK. A Technology-Assisted Telephone Intervention for Work-Related Stress Management: Pilot Randomized Controlled Trial. J Med Internet Res. 2022 Jul 13;24(7):e26569. doi: 10.2196/26569.
    Results Reference
    derived
    Links:
    URL
    http://www.with-me-project.eu/
    Description
    Project website

    Learn more about this trial

    With-Me - Technology-Aided Phone Coaching for Occupational Health Study

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