NCT04771260

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

2.6 years

First QC Date

February 22, 2021

Last Update Submit

October 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Model of care

    For each case study, how health and social care is being delivered will be the main outcome.

    By February 2022

Study Arms (10)

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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2021

First Posted

February 25, 2021

Study Start

January 21, 2021

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations