MulTI-domain Self-management in Older People wiTh OstEoarthritis and Multi-Morbidities (TIPTOE)

Cardiff University requires access to NHS England data for the purpose of the following project:

MulTI-domain Self-management in Older People wiTh OstEoarthritis and Multi-Morbidities (TIPTOE)

The following is a summary of the aims of the research project provided by Cardiff University:

Osteoarthritis (OA) is a common long-term condition, with 85% of people over 70 years old presenting evidence of OA and more than 50% of people exhibiting radiographic evidence of OA in at least one joint by the age of 65. Knee, hip and small joints of the hand are the most commonly affected joints. It is associated with pain, swelling muscle weakness, fatigue and the inability to do everyday tasks. People with OA are more likely to have other co-existing health conditions with large proportions of individuals living with multiple long-term conditions (MLTC) in addition to OA, such as gastrointestinal, cardiovascular, frailty, clinically diagnosed depression, widespread pain and obesity. The prevalence of OA along with MLTC increases with age and with an aging population these numbers are likely to increase. Current NHS usual care for OA is condition specific, and does not consider the interplay between multiple conditions, or support a unified approach between services, healthcare practitioners, the individual with OA and MLTC and their wider personal and social networks provided by friends, family and carers, to help them live well alongside OA and MLTC.

The National Institute for Health and Clinical Excellence (NICE) guidelines for knee and hip OA recommend core non-surgical and non-pharmacological treatments including: (1) self-management education interventions, (2) exercise including strengthening and aerobic fitness, (3) weight loss if obese and (4) use of suitable footwear. Pharmacological recommendations are paracetamol and/or topical non-steroidal anti-inflammatories followed by oral non-steroidal anti-inflammatories and opioids if these are not successful. Referral for surgical opinion is only recommended after individuals have been offered core treatments and when individuals are experiencing symptoms that are of a significant impact on their everyday life. Current clinical guidelines for OA are not underpinned by effectiveness studies conducted with older adults, people with MLTC or individuals from underserved groups, such as those from areas of socioeconomic deprivation or ethnic minorities. There is, therefore, a pressing need to establish evidence-based interventions for this population that are cost effective and – in alignment with long term NHS goals - empower people with OA to make decisions about their health and live well in the presence of multiple conditions.

This randomised, multi-centre, two-arm trial aims to evaluate the clinical and cost-effectiveness of a holistic, personalised self-management support intervention for adults with knee and/or hip OA and MLTC, that will help them to develop the knowledge, skills and confidence they need to manage their own health. The TIPTOE intervention is a personalised living well support intervention that draws on evidence from Bridges Self-management theoretically informed by self-efficacy as the most successful foundation for self-management programmes. The TIPTOE intervention has been proposed as there is a need for a new approach to the management of OA and MLTC that enables individuals and their nominated supporter, to make the decisions about their health, live well and prevent unnecessary treatments.

Individuals with knee and/or hip OA and at least one other medical condition have been recruited and randomly allocated to an intervention or control group. The control group will continue their usual care, as currently provided by the NHS, and the intervention group will receive the new resources and up to six, one-to-one personalised consultations with trained health practitioners. The cost of the intervention will be estimated, and its effects tested on how participants feel and cope with everyday activities. Longer term, the research team will measure if this leads to fewer clinic visits, hospital admissions and operations, by studying information routinely collected when using NHS services.

The primary aim of TIPTOE is to evaluate the cost-effectiveness of the physiotherapy intervention for adults with osteoarthritis and multi-morbidities, and the potential for such approaches to be scaled in the UK. Clinical effectiveness will be assessed through directly collected trial outcomes (musculoskeletal health and pain). In addition to directly collected trial outcomes, Cardiff University are seeking to access participants' NHS records to assess the effects of group allocation (physiotherapy intervention group vs control) on healthcare resource use, and so evaluate any health-economic implications of the intervention through extrapolation of group differences in healthcare resource use during and after the intervention period, in relation to pre-intervention baseline levels.

The following NHS England Data will be accessed:

> Hospital Episode Statistics (HES)

- Admitted Patient Care (APC) – necessary to capture hospital admissions related to the participants’ conditions, including OA and MLTC. By accessing detailed records of inpatient care, we can assess the direct impact of the TIPTOE intervention on the frequency and type of hospitalisations, providing insight into its effect on reducing the need for acute care.

- Critical Care (CC) – necessary to assess any instances where participants required critical care, a potential outcome of severe exacerbations of their conditions. This will help in evaluating the effectiveness of the TIPTOE intervention in preventing severe complications that necessitate intensive treatment.

- Outpatients (OP) – necessary for tracking outpatient consultations, which are frequent for OA and MLTC management. This data will allow us to evaluate how the intervention influences outpatient service use, particularly regarding follow-up appointments, referrals, and specialist consultations.

> Emergency Care Data Set (ECDS) – necessary to track emergency department visits, which are common for individuals with chronic conditions like OA and MLTC when they experience flare-ups or complications. Analysing emergency care usage will provide insight into how the intervention helps in managing health more effectively, thereby reducing the frequency of urgent care needs.

The level of the Data will be:

> Pseudonymised

The Data will be minimised as follows:

> Limited to a study consented cohort identified by Cardiff University – cohort members are individuals with knee and/or hip OA and at least one other medical condition. Cohort members are randomly allocated to an intervention or control group. Recruitment began at the end of January 2024, and is anticipated to end by April 2025, with an anticipated cohort size of 820 participants.

> Limited to data between June 2023 - latest available; data is required for the period 6 months prior to recruitment, during the intervention (up to 6 months) and for the 12 month period after the intervention per individual cohort member. Interventions correspondingly will take part between Feb 2024 and up to October 2025, but will be documented per participant. A start date (6 months before recruitment) and end date (12 months after intervention) will be provided to NHS England per participant to facilitate the cohort linkage process and comply with minimisation requirements.

Cardiff University is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This research serves the public interest by potentially improving clinical outcomes and informing more cost-effective healthcare strategies for the NHS. Furthermore, the study’s findings will contribute to evidence gaps in current clinical guidelines, directly impacting public health policy and healthcare provision.

The funding is provided by the National Institute for Health and Care Research (NIHR). The funding is specifically for the trial described.

The funder(s) will have no ability to suppress or otherwise limit the publication of findings.

Swansea University is a processor acting under the instructions of Cardiff University. Swansea University's role is limited to access and analysis of the pseudonymised healthcare records that will be made available in SAIL, following initial record linkage by NHS England.

The consent and information sheet materials pertaining to this aspect of the trial were developed in concert with Cardiff University’s trial specific Patient and Public Involvement group. A detailed plan for sharing trial results with a wide range of stakeholders was also developed in collaboration with the Public and Patient Involvement group.

Cardiff University (Centre for Trials Research) will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Forename, Surname, Date of Birth, Gender and a unique person ID) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES and ECDS datasets to the Secure Anonymised Information Linkage (SAIL) Databank at Swansea University. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient.

The retained study ID variable will only be used for assigning group allocation (intervention or control).

The Data will not be transferred to any other location.

The Data will be stored on the SAIL Databank at Swansea University.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

The Data will not leave Wales at any time.

Access is restricted to employees or agents of Cardiff University and Swansea University who have authorisation from the Chief Investigator.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will not be linked with any other data.

No identifiable data will be brought into SAIL Databank , nor will pseudonymised healthcare data be taken outside of SAIL Databank to be linked with identifiable data.

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

No individuals will have access to both the pseudonymised NHS England Data and the cohort identifiers.

Researchers from Cardiff University and Swansea University will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

> A report of findings to the funder, NIHR, due August 2026

> Submissions to peer reviewed journals, expected throughout 2026

> Presentations at specific conferences, specifically, Osteoarthritis and Research Society International (OARSI)

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

> Journals

> Conferences

> Online workshops will be held to disseminate findings to key stakeholders such as the public, carers, HPs, charities, researchers and NHS managers

> Social media will be used to disseminate findings to the wider public and infographics

> Posters will be produced to disseminate findings at the locations that were involved in recruitment

Outputs are expected to be produced throughout 2026.

Findings from the study will be disseminated widely to clinicians and policymakers, in collaboration with the public and patient group. Cost-effectiveness evaluations will help fill evidence gaps in existing clinical guidelines – ultimately helping inform decisions around how hip and knee OA management is delivered within the NHS.

The use of the data could:

> help the system to better understand the health and care needs of populations.

> lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

> advance understanding of regional and national trends in health and social care needs.

> advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions such as obesity and diabetes.

> inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

> inform decisions on how to effectively allocate and evaluate funding according to health needs.

> provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

The TIPTOE intervention is a personalised living well support intervention for older adults with osteoarthritis (OA) and multiple long-term conditions (MLTC). Cardiff University hypothesise that the TIPTOE intervention will enable individuals and their nominated supporter to take greater control over decisions about their health, live well and prevent unnecessary treatments. Supplementing directly collected trial outcomes with routine healthcare data will allow Cardiff University researchers to accurately assess the impact of the intervention on healthcare resource use, minimising recall burden for participants and ensuring good long-term follow up. Cardiff University believe that this data will help provide a clearer picture of the potential cost-effectiveness of a self-management intervention for OA and MLTC, leading to better-informed treatment of a common, chronic condition.

Dissemination to clinicians and policymakers: The results will be shared widely with healthcare professionals and decision-makers to influence OA and MLTC care pathways.

Engaging with the public and charities: Collaborations with relevant patient advocacy groups and charities such as Arthritis UK will ensure the dissemination of findings to individuals affected by OA and MLTC. These organisations will help promote research outcomes to a broader audience.

Patient and Public Involvement (PPI): A key element of the dissemination strategy is working closely with the project's PPI group, who will help tailor the findings to ensure that the research results are accessible to patients, their families, and carers. This includes designing clear communication materials such as infographics and accessible summaries.

Social media and public engagement: Social media platforms will be used to engage a wider audience, raise awareness of the study, and share key findings that may influence patient self-management strategies.

Workshops and public engagement activities: Online workshops will be conducted with healthcare providers, policymakers, and the public to present the results and facilitate discussions on how the findings can be integrated into clinical practice. These efforts aim to increase the reach and impact of the research, ensuring that the intervention’s potential benefits are realised across diverse populations.

Yielded Benefits is not a requirement for new applications.