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

April 25, 2016 updated by: VTT Technical Research Centre of Finland
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Technology-aided phone wellness counselling
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.
Behavioral: Phone wellness counselling
The intervention provides phone wellness counseling in occupational health.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VTT Technical Research Centre of Finland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Technical University of Denmark
Firstbeat Technologies Ltd.
Mawell Care Ltd
Mawell Ltd
Oulun Työterveys

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 332885 With-Me-Occ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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