Musculoskeletal PainNCT04695002
Can a Digital Tooll Facilitate Shared Decision-making and Increase Self-efficacy in Vocational Rehabilitation?
An observational study of Musculoskeletal Pain, run by Region MidtJylland Denmark at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- MIRA
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Jan 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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:
- 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.
- To investigate the citizens' experience with and perception of using a digital tool like MIRA in their course of rehabilitation.
- To investigate the professionals' experience with and perception of using a digital tool like MIRA in the course of rehabilitation.
- 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.
- Conditions
- Musculoskeletal Pain
- Being tested
- MIRA, Control
- Keywords
- Rehabilitation, Vocational, Telemedicine
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIRABehavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Control | |
| 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. Receives: Behavioral: MIRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return-to-work Self-efficacy Scale (RTW-SE)
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
Measured: At baseline and at end of rehabilitation, an average of 8 weeks
Secondary outcomes (2)
CollaboRATE
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
Measured: At end of rehabilitation, an average of 8 weeks
WHO-5
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
Measured: At baseline and at end of rehabilitation, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start10 Jan 2021
- Primary completion1 Oct 2021
- Study completion31 Dec 2021
Why it stopped: Too few participants enrolled due to COVID19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region MidtJylland Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus County, Denmark
- Responsible party
- Principal investigator, Nanna Rolving, Region MidtJylland Denmark
- Investigators
- Nanna Rolving, PhD, Principal investigator, Defactum, Central Denmark Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04695002
- Sponsor's protocol ID
- A3156
- Status last verified
- Nov 2022
- First submitted
- 30 Dec 2020
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04695002
- Acronym / sponsor ID
- A3156
- Conditions
- Musculoskeletal Pain
- Keywords
- Rehabilitation, Vocational, Telemedicine
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Too few participants enrolled due to COVID19
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Region MidtJylland DenmarkUniversity, hospital or other
- Collaborators
- Aarhus County, Denmark
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- To investigate the citizens' experience with and perception of using a digital tool like MIRA in their course of rehabilitation.
- To investigate the professionals' experience with and perception of using a digital tool like MIRA in the course of rehabilitation.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Behavioral: ControlCitizens in the control group participate in the existing course of vocational rehabilitation offered in the municipal employment department, without the use of MIRA app. |
| MIRA group | – | Behavioral: MIRACitizens 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIRABased 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. | Behavioural | MIRA group |
| ControlCitizens 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. | Behavioural | Control group |
Primary outcome
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
2 secondary outcomes
CollaboRATE
Time frame: 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
Results and safety
The study was stopped early (reason given: Too few participants enrolled due to COVID19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nanna Rolving, PhD principal investigator
Defactum, Central Denmark Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain, run by Region MidtJylland Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Too few participants enrolled due to COVID19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return-to-work Self-efficacy Scale (RTW-SE) (time frame: At baseline and at end of rehabilitation, an average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.