FibromyalgiaNCT04771260
Understanding Health Services Delivery for Fibromyalgia
An observational study of Fibromyalgia and Fibromyalgia, Primary, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
This research study aims to: i) Explore and understand how health and social care for people with fibromyalgia living in the UK is organised and delivered. ii) Identify models of practice to inform co-design of new care pathways for people with fibromyalgia living in the UK. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Fibromyalgia, Primary, Fibromyalgia, Secondary
- How many people
- 65 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jan 2021to 31 Aug 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants will include healthcare professionals (for example, doctors, nurses, allied health professionals), social care practitioners (for example, social prescribers), service delivery managers, commissioners and other individuals involved in the organisation and delivery of health and social care services for people with fibromyalgia living in the UK.
Who may be able to join
- NHS and/or non-NHS organisations in the UK providing health and social care to people with fibromyalgia.
- Health and social care professionals identifying and or providing support for people with fibromyalgia in one of the ten case studies.
- NHS/non-NHS staff influential in the organisation and/or delivery of health and social care to people with fibromyalgia in one of the ten case studies, for example, service managers, professional service leads, commissioners.
Who cannot join
- NHS/non-NHS organisations in the UK not providing health or social care to people with fibromyalgia.
- NHS/non-NHS staff who are not able to communicate sufficiently well in English to participate effectively.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London
About this study
Official title: A Realist-informed Investigation of the Organisation and Delivery of Health and Social Care Services for People With Fibromyalgia Living in the UK
This research study aims to:
- Explore and understand how health and social care for people with fibromyalgia living in the UK is organised and delivered. ii) Identify models of practice to inform co-design of new care pathways for people with fibromyalgia living in the UK.
To do this, up to ten UK-based case studies will be conducted in total: at least one each in England, Scotland and Wales. Interviews will be conducted with approximately 10 participants per case study, for a total of 100 participant interviews. Qualitative observations (in-person or on-line) will be conducted with a similar number of people (total 100 participants). Online focus groups will also be carried out with approximately 6 to 8 participants per group (up to ten groups for a total 60-80 participants). Participants will include healthcare professionals (for example, doctors, nurses, allied health professionals), social care practitioners (for example, social prescribers), service delivery managers, commissioners and other individuals involved in the organisation and delivery of health and social care services for people with fibromyalgia living in the UK.
- Conditions
- Fibromyalgia, Fibromyalgia, Primary, Fibromyalgia, Secondary
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case study #1 | There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. | |
| Case study #2 | There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. | |
| Case study #3 | There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. | |
| Case study #4 | There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. | |
| Case study #5 | There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. | |
| Case study #6 | There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. | |
| Case study #7 | There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. | |
| Case study #8 | There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. | |
| Case study #9 | There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. | |
| Case study #10 | There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Model of care
For each case study, how health and social care is being delivered will be the main outcome.
Measured: By February 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start21 Jan 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771260
- Sponsor's protocol ID
- 02/068/20
- Status last verified
- Oct 2023
- First submitted
- 22 Feb 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Realist-informed Investigation of the Organisation and Delivery of Health and Social Care Services for People With Fibromyalgia Living in the UK
- ClinicalTrials.gov ID
- NCT04771260
- Acronym / sponsor ID
- 02/068/20
- Conditions
- Fibromyalgia, Fibromyalgia, Primary, Fibromyalgia, Secondary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 25 Feb 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.
This research study aims to:
- Explore and understand how health and social care for people with fibromyalgia living in the UK is organised and delivered. ii) Identify models of practice to inform co-design of new care pathways for people with fibromyalgia living in the UK.
To do this, up to ten UK-based case studies will be conducted in total: at least one each in England, Scotland and Wales. Interviews will be conducted with approximately 10 participants per case study, for a total of 100 participant interviews. Qualitative observations (in-person or on-line) will be conducted with a similar number of people (total 100 participants). Online focus groups will also be carried out with approximately 6 to 8 participants per group (up to ten groups for a total 60-80 participants). Participants will include healthcare professionals (for example, doctors, nurses, allied health professionals), social care practitioners (for example, social prescribers), service delivery managers, commissioners and other individuals involved in the organisation and delivery of health and social care services for people with fibromyalgia living in the UK.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Case study #1 | – | –There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. |
| Case study #2 | – | –There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. |
| Case study #3 | – | –There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. |
| Case study #4 | – | –There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. |
| Case study #5 | – | –There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. |
| Case study #6 | – | –There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. |
| Case study #7 | – | –There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. |
| Case study #8 | – | –There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. |
| Case study #9 | – | –There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. |
| Case study #10 | – | –There will be no intervention. There will be 10 separate case studies, to identify how care for fibromyalgia is being delivered in each case study, and to identify models of care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will include healthcare professionals (for example, doctors, nurses, allied health professionals), social care practitioners (for example, social prescribers), service delivery managers, commissioners and other individuals involved in the organisation and delivery of health and social care services for people with fibromyalgia living in the UK.
Key inclusion criteria (3 listed)
- NHS and/or non-NHS organisations in the UK providing health and social care to people with fibromyalgia.
- Health and social care professionals identifying and or providing support for people with fibromyalgia in one of the ten case studies.
- NHS/non-NHS staff influential in the organisation and/or delivery of health and social care to people with fibromyalgia in one of the ten case studies, for example, service managers, professional service leads, commissioners.
Key exclusion criteria (2 listed)
- NHS/non-NHS organisations in the UK not providing health or social care to people with fibromyalgia.
- NHS/non-NHS staff who are not able to communicate sufficiently well in English to participate effectively.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Model of care
Time frame: By February 2022
For each case study, how health and social care is being delivered will be the main outcome.
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 23 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fibromyalgia and Fibromyalgia, Primary, run by University of Aberdeen at 1 site in United Kingdom.
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 2 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 23 Oct 2023. 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 United Kingdom. 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?
Model of care (time frame: By February 2022). 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 23 Oct 2023.