An observational study in Musculoskeletal Pain, sponsored by Region MidtJylland Denmark. Terminated at 1 site in Denmark. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-11-04.
Sponsored by Region MidtJylland Denmark · Observational
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:
511 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.
This study's enrollment of 20 is below the median of 161 across 141 observational studies indexed under Musculoskeletal Pain.
Browse Musculoskeletal Pain studies →Region MidtJylland Denmark is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 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.
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.
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
Time frame: At baseline and at end of rehabilitation, an average of 8 weeks
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
Time frame: 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
Time frame: At baseline and at end of rehabilitation, an average of 8 weeks
Usability of MIRA
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.
Time frame: At the end of rehabilitation, an average of 8 weeks
Plan to share: 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
No publications or documents are linked to this record.
Ran from Jan 2021 to primary completion in Oct 2021, 8 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Region MidtJylland Denmark