Can a Digital Tooll Facilitate Shared Decision-making and Increase Self-efficacy in Vocational Rehabilitation?

November 1, 2022 updated by: Nanna Rolving, Region MidtJylland Denmark

Does the Application of a Digital Tool With Real-time, Self-reported Data Facilitate Shared Decision-making and Increase Self-efficacy in Vocational Rehabilitation? A Mixed Methods Study

The study investigates both the effects and the experienced value of the mobile application, MIRA, which is a combination of an electronic diary, a dialogue tool and a decision support tool. The individual user registers real-time data reported in a mobile application, e.g. pain, sleep, mood, social activities, work-related activities, based on the goals and condition of the individual user. In this study, users are citizens participating in vocational rehabilitation due to long term sick leave.

The purpose of MIRA is to support a positive and trustful relationship between the citizen and the professional, and to enhance user involvement and shared decision making in the course of rehabilitation. This happens through promotion of the citizens knowledge and understanding of their own health condition and increase his or her self-efficacy, i.e. their ability to cope with their health condition at work and in everyday life.

The study uses a combination of quantitative and qualitative methods, analysed both individually and in combination, where findings of the different methods are combined to provide a deeper understanding of the positive and negative effects of using MIRA in vocational rehabilitation.

In this way the study investigates both the effect of applying a digital tool, such as MIRA, on a number of quantifiable measures (using questionnaires), and at the same time the study explores what works for whom and why using qualitative and combined methods. In this way, the study aims to contribute with knowledge in a balanced manner, regarding the pros and cons of using digital tools with real-time self-reported data in rehabilitation.

The study aim will be fulfilled through the following sub-purposes:

  1. To investigate the effect of using MIRA in a course of vocational rehabilitation in relation to the citizens' self-efficacy for pain and work and their experience of shared decision-making in the course of rehabilitation.
  2. To investigate the citizens' experience with and perception of using a digital tool like MIRA in their course of rehabilitation.
  3. To investigate the professionals' experience with and perception of using a digital tool like MIRA in the course of rehabilitation.
  4. To investigate the mechanisms of effect of MIRA (i.e. what works for whom and why), through and integrated analysis of the findings of sub-purpose 1-3.

Study Overview

Status

Status

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

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.

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.
Observational

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.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Sociallægeinstitutionen

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study takes place in a multidisciplinary health care unit in a municipal employment department in Denmark. The study population consists of citizens who referred from the job centre due to limitations in their work ability, as assessed by the case managers, due to musculoskeletal and/or stress-related disorders (the two conditions are often interrelated). In the present study only citizens with a sufficient level of Danish are included, as the MIRA-app only exists in a Danish version. Citizens are between the age of 18 and 68 (i.e, working age), and may be employed, but on prolonged sick leave, or may be unemployed.

Description

Inclusion Criteria:

  • Referred for a course of vocational rehabilitation at a multidisciplinary health care unit at a municipal employment department.
  • On sick leave or unemployed due to musculoskeletal or stress-related disorders
  • In the working age (18 - 68 years approximately)

Exclusion Criteria:

  • On sick leave or unemployed for other reasons, e.g. psychiatric disorders or cancer;
  • Under the age of 18 or older than 68 years (approximately)
  • Not sufficiently familiar with Danish language to use the MIRA app as intended.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Control group
Citizens in the control group participate in the existing course of vocational rehabilitation offered in the municipal employment department, without the use of MIRA app.
Behavioral: Control
Citizens in the control group participate in the standard course of vocational rehabilitation, without the use of MIRA app. Citizens are referred from the jobcenter if the case manager assesses that a health condition limits the citizen's ability to resume work. The typical course of rehabilitation lasts 4-12 weeks, and is managed by a physiotherapist, a psychologist and a physician. Depending on the condition of the citizen, the rehabilitation may be managed by only two of the three professionals. During the course of rehabilitation, the citizen may consult the team with varying frequency. If physical rehabilitation is part of the prescribed rehabilitation, the citizen shows up twice per week for several weeks of supervised exercise, whereas rehabilitation courses where self-management is in focus, only biweekly consultations may be provided. The decisions and planning of contents and duration of the rehabilitation programme is done in collaboration with the citizen.
MIRA group
Citizens in the MIRA group will participate in the existing course of vocational rehabilitation offered in the municipal department. In addition they will be introduced to MIRA at the beginning of the rehabilitation course, and use MIRA throughout the course of rehabilitation.
Behavioral: MIRA
Based on the initial assessment, the citizen and professional agree what outcomes the citizen should report in MIRA. This could be pain, mood, sleep quality, energy level, dependent on the priorities of the citizen. Similarly, different activities are reported, e.g. exercise, social activities, prolonged sitting or work-related tasks. The citizen and the professional agree how often the citizen reports the outcomes and tasks, and the citizen is notified by the MIRA-app when it's time for reporting. The data will be visualized in a graph for the professional in the back-end of the system, making it possible for the citizen and the professional to view the same, real-time reported data. This provides the base for discussing and adjusting the course of rehabilitation as symptoms change over time. At the same time, this increases the citizen's knowledge of how symptoms, mood, sleep and activities all interact, thereby giving them the tools better cope with their health condition.

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
Return-to-work Self-efficacy Scale (RTW-SE)
Time Frame: At baseline and at end of rehabilitation, an average of 8 weeks
The RTW-SE is a 10-item questionnaire measuring the respondent's self-efficacy for coping with their health condition in relation to returning to work. Score ranges from 10-50 points, with 50 points reflecting the highest level of self-efficacy
At baseline and at end of rehabilitation, an average of 8 weeks

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
CollaboRATE
Time Frame: At end of rehabilitation, an average of 8 weeks
CollaboRATE is a 3-item questionnaire, measuring to what extent the respondent feels involved in the decision making process in their course of rehabilitation (i.e. shared decision making) on a scale of 0-9 (worst-best). An average score of the three items is calculated
At end of rehabilitation, an average of 8 weeks
WHO-5
Time Frame: At baseline and at end of rehabilitation, an average of 8 weeks
WHO5-index is a 5-item generic questionnaire for measuring self-reported quality of life and general well-being. Each item is scored on a scale of 5 (best) to 0 (worst), adding up to a total score of 0-25
At baseline and at end of rehabilitation, an average of 8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Usability of MIRA
Time Frame: At the end of rehabilitation, an average of 8 weeks
For participants in the MIRA group 4 questions regarding the usability of MIRA is applied, e.g. the need for technical support in the use of MIRA.
At the end of rehabilitation, an average of 8 weeks

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.
Region MidtJylland Denmark

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.
Aarhus County, Denmark

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: Nanna Rolving, PhD, Defactum, Central Denmark Region

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 (Actual)

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.
January 10, 2021

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.
October 1, 2021

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.
December 31, 2021

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).
December 30, 2020

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.
January 4, 2021

First Posted (Actual)

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.
January 5, 2021

Study Record Updates

Last Update Posted (Actual)

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.
November 4, 2022

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.
November 1, 2022

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.
November 1, 2022

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.
  • A3156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

As the data are owned by the municipality participating in the study, the primary investigator/study official is not allowed to share individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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