Musculoskeletal Diseases or ConditionsRTW-GPNCT03004989
Experiences of Participating in Return to Work Group Programmes
An observational study of Musculoskeletal Diseases or Conditions, run by Revmatismesykehuset AS at 1 site in Norway.
Trial summary
To explore the experiences of individuals with musculoskeletal disorders (MSDs) who have participated in return-to-work group programmes (RTW-GPs) and see how the programmes could strengthen their work ability. Read more about this study
- Who is it for?
- Ages 28 to 57 years, women only
- Conditions the study is for
- Musculoskeletal Diseases or Conditions
- What is being tested?
- Programme
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 17 participants
- Where
- 1 siteNorway
- Study dates
- May 2012to Jan 2016
- 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 28 to 57 years
- Women only
- No healthy volunteers
- Adult
Study population: A total of 17 female informants participated in the study, age 28 - 57 years
Who may be able to join
- Participating RTW-GP
- Musculoskeletal diagnoses
- From the rural district/city of residence
- Speaking Norwegian
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experiences of Participating in Return to Work Group Programmes for People With Musculoskeletal Disorders: A Focus Group Study
To explore the experiences of individuals with musculoskeletal disorders (MSDs) who have participated in return-to-work group programmes (RTW-GPs) and see how the programmes could strengthen their work ability.
Read the detailed description
For a representative sampling of experiences, participants who had participated in various groups over time in outpatient and inpatient groups in the RTW-GP were invited to enrol in the study. Other inclusion criteria were age between 25 and 65 years, different musculoskeletal diagnosis and that they should come from the rural district/city of residence.
The participants received requests by letter to participate in the focus group interview six months after the final group intervention, the same time as they were invited to a follow-up visit. Only a few men had participated in the RTW-GPs and none of them wanted to take part in the study.
All participants were given written and oral information about the study, the use of recording and transcribing devices, and their right to withdraw from the study at any time. The interviews were carried out after the participants gave written, informed consent.
Three focus group interviews were conducted: one with six participants, and two with five. One participant who could not participate in the focus group interview participated at an individual interview with the same questions as in the focus groups. The individual interview was conducted first and served as a test for the questions in the interview guide.
Interventions The participants of this study had participated in one of three different RTW-GPs. These programmes are designed to enable participants to proactively take action in their daily lives and in collaboration with employers achieve the best possible working conditions. All the group sessions are based on cognitive theory where attention, awareness and reflection on one's own work and life situation is important. Motivation is instilled by helping participants recognise opportunities for change. Participants set work-related goals and receive individual feedback from multidisciplinary personnel in addition to various group-based sessions with teaching, activities and exercises. The participants are referred to the programme by a rheumatologist or a member of the hospital's multidisciplinary team as soon as possible after starting sick-leave.
- Conditions
- Musculoskeletal Diseases or Conditions
- Being tested
- Programme
- Keywords
- Qualitative study, Musculoskeletal Disorders, Return to Work Programme
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgrammeBehavioural
Also called Programme 1, Programme 2, Programme 3
The participants of this study had participated in one of three different RTW-GPs. These programmes are designed to enable participants to proactively take action in their daily lives and in collaboration with employers achieve the best possible working conditions. All the group sessions are based on cognitive theory where attention, awareness and reflection on one's own work and life situation is important
| Study group | Role | What they receive |
|---|---|---|
| Programme 1 | RTW group in day clinics Receives: Behavioral: Programme | |
| Programme 2 | RTW group in day clinics for people with fibromyalgia Receives: Behavioral: Programme | |
| Programme 3 | My work and I Receives: Behavioral: Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient experiences after participating at RTW-GP
Focus group interviews
Measured: May 2012 - November 2013
Quality of life
Focus group interviews
Measured: May 2012 - November 2013
Work ability
Focus group interview
Measured: May 2012 - November 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startMay 2012
- Primary completionNov 2013
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal Diseases or ConditionsStudies 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
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revmatismesykehuset AS
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Responsible party
- Sponsor
- Investigators
- Bente Hamnes, PhD, Study chair, Revmatismesykehuset AS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004989
- Sponsor's protocol ID
- 2012/7266 UiO
- Acronym
- RTW-GP
- Status last verified
- Dec 2016
- First submitted
- 20 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences of Participating in Return to Work Group Programmes for People With Musculoskeletal Disorders: A Focus Group Study
- ClinicalTrials.gov ID
- NCT03004989
- Acronym / sponsor ID
- RTW-GP / 2012/7266 UiO
- Conditions
- Musculoskeletal Diseases or Conditions
- Keywords
- Qualitative study, Musculoskeletal Disorders, Return to Work Programme
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Revmatismesykehuset ASUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority
- Study start
- May 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 29 Dec 2016 (estimated)
- 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.
To explore the experiences of individuals with musculoskeletal disorders (MSDs) who have participated in return-to-work group programmes (RTW-GPs) and see how the programmes could strengthen their work ability.
Detailed description
For a representative sampling of experiences, participants who had participated in various groups over time in outpatient and inpatient groups in the RTW-GP were invited to enrol in the study. Other inclusion criteria were age between 25 and 65 years, different musculoskeletal diagnosis and that they should come from the rural district/city of residence.
The participants received requests by letter to participate in the focus group interview six months after the final group intervention, the same time as they were invited to a follow-up visit. Only a few men had participated in the RTW-GPs and none of them wanted to take part in the study.
All participants were given written and oral information about the study, the use of recording and transcribing devices, and their right to withdraw from the study at any time. The interviews were carried out after the participants gave written, informed consent.
Three focus group interviews were conducted: one with six participants, and two with five. One participant who could not participate in the focus group interview participated at an individual interview with the same questions as in the focus groups. The individual interview was conducted first and served as a test for the questions in the interview guide.
Interventions The participants of this study had participated in one of three different RTW-GPs. These programmes are designed to enable participants to proactively take action in their daily lives and in collaboration with employers achieve the best possible working conditions. All the group sessions are based on cognitive theory where attention, awareness and reflection on one's own work and life situation is important. Motivation is instilled by helping participants recognise opportunities for change. Participants set work-related goals and receive individual feedback from multidisciplinary personnel in addition to various group-based sessions with teaching, activities and exercises. The participants are referred to the programme by a rheumatologist or a member of the hospital's multidisciplinary team as soon as possible after starting sick-leave.
Study design
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Programme 1 | – | Behavioral: ProgrammeRTW group in day clinics |
| Programme 2 | – | Behavioral: ProgrammeRTW group in day clinics for people with fibromyalgia |
| Programme 3 | – | Behavioral: ProgrammeMy work and I |
Who may qualify
- Ages
- 28 to 57 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A total of 17 female informants participated in the study, age 28 - 57 years
Key inclusion criteria (4 listed)
- Participating RTW-GP
- Musculoskeletal diagnoses
- From the rural district/city of residence
- Speaking Norwegian
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ProgrammeAlso: Programme 1, Programme 2, Programme 3The participants of this study had participated in one of three different RTW-GPs. These programmes are designed to enable participants to proactively take action in their daily lives and in collaboration with employers achieve the best possible working conditions. All the group sessions are based on cognitive theory where attention, awareness and reflection on one's own work and life situation is important | Behavioural | Programme 1, Programme 2, Programme 3 |
Primary outcome
Patient experiences after participating at RTW-GP
Time frame: May 2012 - November 2013
Focus group interviews
Quality of life
Time frame: May 2012 - November 2013
Focus group interviews
Work ability
Time frame: May 2012 - November 2013
Focus group interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Bente Hamnes, PhD study chair
Revmatismesykehuset AS
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 Diseases or Conditions, run by Revmatismesykehuset AS at 1 site in Norway.
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 4 inclusion and 0 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: finished, as of the sponsor's last update on 2 Jan 2017. 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 Norway. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient experiences after participating at RTW-GP (time frame: May 2012 - November 2013). The study lists 3 primary outcomes in all. 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 2 Jan 2017.