The MIDAS Population Study – Joining up data and action to improve musculoskeletal health for all
| ISRCTN | ISRCTN10575867 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10575867 |
| IRAS number | 315830 |
| Secondary identifying numbers | RG-0327-21, IRAS 315830, CPMS 53758 |
- Submission date
- 04/08/2022
- Registration date
- 05/08/2022
- Last edited
- 08/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Musculoskeletal disorders are the main drivers of non-communicable disease disability burden in most countries and regions worldwide. In England they account for an estimated 21% of total years lived with a disability.
The MIDAS-Population Study aims to provide a detailed description of musculoskeletal health, key comorbidity and the impact of health inequalities and care within the general population.
Who can participate?
Adults aged 35 years and over who are registered with a participating general practice for the study period and are able to provide informed consent.
What does the study involve?
Eligible participants will be invited to participate via a text message from their general practice containing a link URL to the online survey.
Patients who do not have a mobile telephone number registered with their practice will be invited to participate by post.
What are the possible benefits and risks of participating?
Although there is no immediate direct benefit, some people find it rewarding to take part in health research. Participants in this study will help to support how doctors and physiotherapists treat people with musculoskeletal symptoms involving back, neck, joint or muscle pain and understand the local need for treatment and which groups of people are most under-served by the NHS at present. There are no risks to participants taking part in this study.
Where is the study run from?
Keele University Clinical Trials Unit (UK)
When is the study starting and how long is it expected to run for?
August 2022 to March 2025
Who is funding the study?
Nuffield Foundation (UK)
Who is the main contact?
Clare Thompson, c.thompson1@keele.ac.uk
Contact information
Public
Clinical Trials Unit
School of Medicine
Keele University
Newcastle under Lyme
ST5 5BQ
United Kingdom
| Phone | +44 1782 734886 |
|---|---|
| c.thompson1@keele.ac.uk |
Principal Investigator
Primary Care Centre Versus Arthritis
School of Medicine
Keele University
Newcastle under Lyme
ST5 5BQ
United Kingdom
| Phone | +44 1782 734845 |
|---|---|
| r.wilkie@keele.ac.uk |
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Multi-level Integrated Data for Musculoskeletal Health Intelligence and Actions: Population Survey |
| Study acronym | MIDAS-Population Survey |
| Study hypothesis | To describe musculoskeletal health and inequalities in the adult population. To describe and compare the biopsychosocial context of adults with musculoskeletal health problems and to relate local estimates of musculoskeletal health need with use of healthcare services. |
| Ethics approval(s) | Approved 01/09/2022, Wales Research Ethics Committee 2 (15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)7976 982591, +44 (0)2920 230457; Wales.REC2@wales.nhs.uk), ref: 22/WA/0256 |
| Condition | Musculoskeletal conditions in the adult population aged 35 years and over |
| Intervention | Adults aged 35 years and over in the North Staffordshire and Stoke on Trent area will be invited to complete a questionnaire that collects information on pain and its effects on people. with a focus on disability and work. Participants will have the option to complete the survey either online or by postal return. If consent is obtained, their questionnaire responses will be linked with information held in their medical records. |
| Intervention type | Other |
| Primary outcome measure | High impact chronic pain is measured at baseline. The method used to measure the outcome is questionnaire. |
| Secondary outcome measures | Work participation which is measured by questionnaire at baseline. |
| Overall study start date | 01/08/2022 |
| Overall study end date | 31/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 35 Years |
| Sex | Both |
| Target number of participants | 3400 |
| Total final enrolment | 3181 |
| Participant inclusion criteria | 1. People aged 35 years and over 2. Registered with a participating general practice during the study period 3. Able to provide informed consent |
| Participant exclusion criteria | 1. Has declined to be contacted about research studies recorded in their EHR Added 01/09/2022: 2. Patients receiving palliative care, patients residing in a nursing home, patients with severe mental illness and patients who are recently bereaved |
| Recruitment start date | 10/10/2022 |
| Recruitment end date | 15/08/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Newcastle Under Lyme
ST5 5BG
United Kingdom
Sponsor information
University/education
Directorate of Research, Innovation and Engagement
Innovation Centre 2
Newcastle-under-Lyme
ST5 5NH
England
United Kingdom
| Phone | +44 1782 732975 |
|---|---|
| research.governance@keele.ac.uk | |
| Website | http://www.keele.ac.uk/ |
"ROR" |
https://ror.org/00340yn33 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high impact peer reviewed journal |
| IPD sharing plan | IPD will be securely stored on servers approved by the government backed cyber security scheme. Unless their are exceptional circumstances data will be available upon publication of main study findings. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 17/08/2022 | 01/09/2022 | No | No |
| Protocol file | version 3.0 | 01/09/2022 | 06/10/2022 | No | No |
| Protocol file | version 6.0 | 19/01/2023 | 02/03/2023 | No | No |
| Protocol file | version 7.0 | 30/01/2023 | 13/03/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
08/10/2024: Total final enrolment added.
22/09/2023: The target number of participants was changed from 4495 to 3400.
23/08/2023: The recruitment end date was changed from 01/11/2023 to 15/08/2023.
16/03/2023: The recruitment end date was changed from 28/04/2023 to 01/11/2023.
13/03/2023: Protocol file uploaded.
02/03/2023: The following changes were made to the trial record:
1. Protocol file uploaded (not peer reviewed).
2. The recruitment end date was changed from 31/03/2023 to 28/04/2023.
13/12/2022: The recruitment end date was changed from 31/12/2022 to 31/03/2023.
21/10/2022: Contact details updated.
19/10/2022: The recruitment start date was changed from 03/10/2022 to 10/10/2022.
06/10/2022: Uploaded protocol (not peer reviewed).
27/09/2022: The recruitment start date was changed from 12/09/2022 to 03/10/2022.
05/09/2022: Internal review.
01/09/2022: Protocol file uploaded. The ethics approval and exclusion criteria were updated.
05/08/2022: Trial's existence confirmed by Wales REC 4
