Multi-domain self-management in older people with osteoarthritis and multimorbidities: protocol for the TIPTOE randomised controlled trial

Deere, Rachel, Pallmann, Philip ORCID: https://orcid.org/0000-0001-8274-9696, Shepherd, Victoria ORCID: https://orcid.org/0000-0002-7687-0817, Brookes-Howell, Lucy ORCID: https://orcid.org/0000-0002-8263-7130, Carson-Stevens, Andrew ORCID: https://orcid.org/0000-0002-7580-7699, Davies, Ffion, Dunphy, Emma, Gupta, Preeti, Hickson, Mary, Hill, Val, Ingarfield, Kate, Ivins, Nicola, Jones, Fiona, Letchford, Robert, Lowe, Rachel, Nash, Sarah, Otter, Paula, Prout, Hayley ORCID: https://orcid.org/0000-0003-0170-7027, Randell, Elizabeth ORCID: https://orcid.org/0000-0002-1606-3175, Sewell, Bernadette, Smith, Debs, Trubey, Robert, Wainwright, Tom, Busse, Monica and Button, Kate ORCID: https://orcid.org/0000-0003-1073-9901 2024. Multi-domain self-management in older people with osteoarthritis and multimorbidities: protocol for the TIPTOE randomised controlled trial. Trials 25 , 557. 10.1186/s13063-024-08380-7

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Abstract

Background: Four out of five people living with osteoarthritis (OA) also suffer with at least one other long-term health condition. The complex interaction between OA and multiple long-term conditions (MLTCs) can result in difficulties with self-care, restricted mobility, pain, anxiety, depression and reduced quality of life. The aim of the MulTI-domain Self-management in Older People wiTh OstEoarthritis and Multi-Morbidities (TIPTOE) trial is to evaluate the clinical and cost-effectiveness of the Living Well self-management support intervention, co-designed with people living with OA, integrated into usual care, in comparison to usual care alone. Methods: TIPTOE is a multi-centre, two-arm, individually randomised controlled trial where 824 individuals over 65 years old with knee and/or hip joint pain from their OA affected joint and at least one other long-term health condition will be randomised to receive either the Living Well Self-Management support intervention or usual care. Eligible participants can self-refer onto the trial via a website or be referred via NHS services across Wales and England. Those randomised to receive the Living Well support intervention will be offered up to six one-to-one coaching sessions with a TIPTOE-trained healthcare practitioner and a co-designed book. Participants will be encouraged to nominate a support person to assist them throughout the study. All participants will complete a series of self-reported outcome measures at baseline and 6- and 12-month follow-up. The primary outcome is symptoms and quality of life as assessed by the Musculoskeletal Health Questionnaire (MSK-HQ). Routine data will be used to evaluate health resource use. A mixed methods process evaluation will be conducted alongside the trial to inform future implementation should the TIPTOE intervention be found both clinically and cost-effective. An embedded ‘Study Within A Project’ (SWAP) will explore and address barriers to the inclusion of under-served patient groups (e.g. oldest old, low socioeconomic groups, ethnic groups). Discussion: TIPTOE will evaluate the clinical and cost-effectiveness of a co-designed, living well personalised self-management support intervention for older individuals with knee and/or hip OA and MLTCs. The trial has been designed to maximise inclusivity and access.

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	Centre for Trials Research (CNTRR)
Date of First Compliant Deposit:	23 August 2024
Date of Acceptance:	6 August 2024
Last Modified:	28 Aug 2024 10:33
URI:	https://orca.cardiff.ac.uk/id/eprint/171567

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