The clinical and cost effectiveness of a personalised living well support package on health-related quality of life in older people with knee and/or hip joint pain and at least one other long term health condition
| ISRCTN | ISRCTN16024745 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16024745 |
| IRAS number | 324783 |
| Secondary identifying numbers | CPMS 58743, IRAS 324783 |
- Submission date
- 05/10/2023
- Registration date
- 16/10/2023
- Last edited
- 09/04/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Knee and hip osteoarthritis affect 1 in 2 adults aged over 70 years with nearly 7 in 10 osteoarthritis sufferers having more than one medical condition, resulting in complex health needs. Demand for treatment is high but care across services is often fragmented and not based on individual user needs and preferences. The complex interaction of painful arthritis and long-term conditions is associated with reduced independence and quality of life in terms of self-care, mobility, activity levels, pain, anxiety, and depression. Individuals with arthritis and multiple long-term conditions (MLTC) are also less active than the general population, which has a negative impact on their physical and mental health. They often struggle with the knowledge, confidence, and skills to self-manage their health alongside their arthritis. Overall, arthritis and MLTCs can lead to high demand for coordinated care across different services, and admission to hospital, which is costly to the individual and society. Holistic personalised treatments for older adults that help them live well alongside managing their arthritis and MLTCs are urgently needed.
The aim of the study is to evaluate how effective this new TIPTOE living well support is and see whether it can help individuals with knee and/or hip joint pain and other long-term conditions understand their conditions more and be able to cope with the challenges they experience in everyday life.
Who can participate?
People aged 65 years and older who are living independently in the community, or with carer support or in assisted living. You must also have knee and/or hip joint pain, which is impacting on daily living, and at least one other long-term mental or physical health condition.
What does the study involve?
Participants who are randomised to receive the personalised living well support package (TIPTOE intervention) will receive up to six, one-to-one coaching sessions with trained healthcare practitioners and be sent a living well book which features stories and tips from people living with joint pain. Those who are randomised to the control group will continue to receive their usual care.
What are the possible benefits and risks of participating?
At this stage of the research, we don’t know if there will be any direct benefits for you but by being involved you will help us gather evidence about different ways that may help individuals with knee and/or hip joint pain and other long-term condition(s) manage better in everyday life. There is a chance that you might find some topics sensitive or challenging whilst taking part in one-to-one support sessions or whilst answering questionnaires.
Where is the study run from?
The study is being sponsored by Cardiff University and the Centre for Trials Research at Cardiff University is managing the study on a day-to-day basis. We have worked extensively with a Patient and Public Involvement (PPI) group who have helped us shape the study.
When is the study starting and how long is it expected to run for?
January 2023 to August 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
The study team can be contacted at TIPTOE@cardiff.ac.uk
Contact information
Scientific
Centre for Trials Research
College of Biomedical & Life Sciences
7th Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
| Phone | +44 (0)2920 687074 |
|---|---|
| RandellE@cardiff.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | To follow |
| Scientific title | MulTI-domain Self-management in Older People wiTh OstEoarthritis and Multi-Morbidities |
| Study acronym | TIPTOE V1.0 |
| Study hypothesis | Participants receiving the TIPTOE, personalised multi-dimensional self-management intervention, in addition to treatment as usual will have different outcomes as measured by the Musculoskeletal Health Questionnaire, than those receiving treatment as usual alone. |
| Ethics approval(s) |
Approved 18/09/2023, Wales REC 2 (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 2922 941119; Wales.REC2@wales.nhs.uk), ref: 23/WA/0221 |
| Condition | Knee and hip osteoarthritis |
| Intervention | Intervention Name: TIPTOE personalised living well support intervention Intervention Details: The trial intervention is a self-management-based approach described as TIPTOE living well support. It will involve six one-to-one (lasting up to 60 minutes) personalised living well support coaching sessions (over 6 months) incorporating digital, and paper-based living well support resources applicable to this population. Individual coaching sessions will primarily be delivered face-to face through clinics, community services or within participants homes, with the option of remote delivery where required. The available resources will include stories and narratives of the experiences, challenges and successes of other people living with Osteoarthritis and Multiple Long-Term Conditions, which might act as a source of ideas or motivation. Participants allocated to the intervention arm will receive coaching sessions by Healthcare Professionals (HPs), including physiotherapists, occupational therapists, and nurses, who have experience of working with people with complex health problems from primary and secondary care or community settings. Participants will also gain access to the co-designed Living Well with Joint Pain book. Space within the book will allow individuals to record goals and plans, explore personal social networks and reflect on progress. The book will also be available as an interactive PDF with links to digital resources and updates. All HPs will be trained in Bridges self-management that has been adapted for TIPTOE. This will mean that practitioners will develop the knowledge, skills, and confidence to facilitate the coaching sessions in a collaborative and non-directive way whilst also addressing concepts such as polypharmacy, physical activity, weight management, nutrition, safety, and frailty in their conversations (if required). The training will allow HPs to reflect on the social context of the individual and to value the skills and experiences of individuals and their nominated supporter. The control group will receive usual care. |
| Intervention type | Behavioural |
| Primary outcome measure | Musculoskeletal Health Questionnaire (MSK-HQ) measured at baseline, 6- and 12-month follow up |
| Secondary outcome measures | 1. Chronic disease self-efficacy as measured on the Self-Efficacy Scale for managing Chronic Diseases (SESMCD) at baseline, 6- and 12-months follow up. 2. Directly measured step count, using an ActivPAL physical activity monitor. Physical activity monitoring will be completed at baseline, and at 12-months follow-up. 3. Aspects of health related QoL as measured on the EQ-5D-5L questionnaire at baseline, 6- and 12-month follow up. 4. Self-Assessment of frailty as measured on the Pictorial Fit-Frail Scale (PFFS) at baseline, 6- and 12-month follow up. 5. Number of falls recorded using a Falls History Questionnaire at baseline and at 6- and 12-months follow-up. 6. Healthcare resource use, obtained through consented linkage to NHS Digital and SAIL. Datasets will include primary care (where available), hospital admissions, surgery, outpatient, and emergency care. A CSRI will also be used to capture additional healthcare resource use, which cannot be obtained through NHS Digital or SAIL in the detail required (e.g., primary care data, social care data, prescription data). Completed at baseline, 6- and 12-month follow up. 7. Health literacy as measured on the Health Literacy Questionnaire (HLQ). The HLQ evaluates the cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand and use information in a way that promotes and maintains good health. We will be employing a sub-set of domains from the HLQ which cover basic/functional health literacy and communicative/interactive health literacy. The HLQ will only be completed at baseline only. |
| Overall study start date | 01/01/2023 |
| Overall study end date | 01/08/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 824; UK Sample Size: 824 |
| Participant inclusion criteria | Current inclusion criteria as of 10/10/2024: 1. Aged 65 years or older 2. Living in the community independently, or with carer support, or in assisted living 3. With self-reported knee and/or hip joint pain in the osteoarthritis affected joint, with an average pain severity in the past week of 4 or greater on a 0-10 numerical rating scale 4. Osteoarthritis and at least one other co-morbidity identified using the self-administered co-morbidity questionnaire or 5. Osteoarthritis and mild to moderate clinical frailty on the CHSA Clinical Frailty Scale (for clinician referral routes only) Previous inclusion criteria: 1. Aged 70 years or older 2. Living in the community independently, or with carer support, or in assisted living 3. With self-reported knee and/or hip joint pain in the osteoarthritis-affected joint, with an average pain severity in the past week of 4 or greater on a 0-10 numerical rating scale 4. Osteoarthritis and at least one other co-morbidity identified using the self-administered co-morbidity questionnaire or 5. Osteoarthritis and mild to moderate clinical frailty on the CHSA Clinical Frailty Scale (for clinician referral routes only) |
| Participant exclusion criteria | 1. Joint pain attributed to a palliative condition or fracture 2. Knee and/or hip surgery or joint replacement in the last 12 months 3. Living in a care home (residential or nursing care) |
| Recruitment start date | 10/01/2024 |
| Recruitment end date | 31/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
7th Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
Maes-y-coed Road
Cardiff
CF14 4HH
United Kingdom
Poole Hospital
Longfleet Road
Poole
BH15 2JB
United Kingdom
London
E9 6SR
United Kingdom
200 Western Avenue
Cardiff
CF5 2YB
United Kingdom
Sheffield
S10 2TB
United Kingdom
Albert Road
Pontypridd
CF37 1LB
United Kingdom
Princes Drive
Colwyn Bay
LL29 8PL
United Kingdom
Bronllys Hospital
Brecon
LD3 0LY
United Kingdom
Tonna Uchaf
Tonna
Neath
SA11 3LX
United Kingdom
Wigan Lane
Wigan
WN1 2NN
United Kingdom
Newquay
TR7 1RJ
United Kingdom
Galmpton
Brixham
Q5 0PG
United Kingdom
Bridgwater
TA6 4GP
United Kingdom
Le Molay-littry Way
Bovey Tracey
Newton Abbot
TQ13 9QP
United Kingdom
Sponsor information
University/education
Park Place
Cardiff
CF10 3AT
Wales
United Kingdom
| Phone | +44 (0)2920688359 |
|---|---|
| resgov@cardiff.ac.uk | |
| Website | http://www.cardiff.ac.uk/ |
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/08/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Data can be requested via the Centre for Trials Research (CTR) at Cardiff University through the completion of a data request form Data requests - Centre for Trials Research - Cardiff University. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 23/08/2024 | 27/08/2024 | Yes | No |
Editorial Notes
09/04/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/04/2025 to 31/08/2025.
2. Contact details updated.
10/10/2024: The inclusion criteria were updated. The study participating centres were updated to add Cwm Taf Morgannwg University Local Health Board, Betsi Cadwaladr University Lhb Colwyn Bay Office, Powys Teaching Local Health Board, Swansea Bay University Local Health Board, Wigan and Leigh Health Services NHS Trust, Newquay Health Centre, Compass House Medical Centre, East Quay Medical Centre, and Bovey Tracey & Chudleigh Practice.
27/08/2024: Publication reference added.
11/12/2023: The recruitment start date was changed from 01/12/2023 to 10/01/2024.
06/12/2023: Llandaff Campus (podiatry) and Sheffield Teaching Hospitals NHS Trust - Optical Site were added as study participating centres.
05/10/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
