INITIATE: Increased mobility in hospital after hip fracture
| ISRCTN | ISRCTN13661431 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13661431 |
| IRAS number | 336892 |
| Secondary identifying numbers | NIHR150983, CPMS 62672, IRAS 336892 |
- Submission date
- 16/07/2024
- Registration date
- 22/07/2024
- Last edited
- 27/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Each year there are 70,000 new hip fractures in the UK, with an ongoing annual cost to health and social care services of £3 billion. After this injury, mobility and independence are so badly affected that one in six people never return home. This downward spiral of immobility and dependence contributes to a quarter of people dying within one year of the injury. National mobility targets have been set for hospitals. Firstly patients should be helped out of bed within 48 hours of receiving surgery and secondly, they should receive two hours of rehabilitation per week. Patients whose care exceeds these targets seem to recover more quickly than other patients. Consequently, patients and their carers have asked if increasing ward-based mobilising would allow people to get back home more quickly and to continue living independently. This study wants to find out if more ward-based mobilisation activity after hip fracture surgery allows people to get home quicker and allows them to stay living in their own homes longer.
Who can participate?
Adults aged ≥ 60 years having surgery for a fracture of the hip
What does the study involve?
Study participants will provide additional data to the research team at baseline (during their hospital stay), and then around 30 days and 120 days after their surgery.
What are the possible benefits and risks of participating?
There is no specific advantage to taking part in this study. However, the study results will help to improve the care of patients with a broken hip in the future.
Where is the study run from?
The study is run by the Oxford Trauma and Emergency Care research group, which is part of the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences of the University of Oxford.
When is the study starting and how long is it expected to run for?
April 2024 to November 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) through its Health Technology Assessment (HTA) programme
Who is the main contact?
1. Prof Matt Costa, matthew.costa@ndorms.ox.ac.uk
2. Prof Rebecca Kearney, becky.kearney@bristol.ac.uk
Contact information
Public, Scientific
INITIATE Trial Manager, Kadoorie Centre, Level 3, John Radcliffe Hospital, Headley Way
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 227226 |
|---|---|
| initiate@ndorms.ox.ac.uk |
Principal Investigator
Chief Investigator, Kadoorie Centre, Level 3, John Radcliffe Hospital, Headley Way
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0003-3644-1388 |
|---|---|
| Phone | +44 (0)1865 223114 |
| matthew.costa@ndorms.ox.ac.uk |
Principal Investigator
Co-Lead Investigator, Bristol Trials Centre, Bristol Medical School, 1–5 Whiteladies Road, Clifton
Bristol
BS8 1NU
United Kingdom
| ORCID ID |
0000-0002-8010-164X |
|---|---|
| Phone | +44 (0)117 4551727 |
| becky.kearney@bristol.ac.uk |
Study information
| Study design | Multi-centre two-arm unblinded cluster randomized controlled trial with embedded process and economic evaluations |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital, Medical and other records, Telephone |
| Study type | Treatment |
| Participant information sheet | Patient information material can be found at https://initiate.octru.ox.ac.uk/ |
| Scientific title | INITIATE: Increased mobility in hospital after hip fracture |
| Study acronym | WHiTE 15: INITIATE |
| Study hypothesis | To determine whether a usual care rehabilitation strategy or usual care with an additional mobility-focused intervention is superior for patients aged ≥ 60 years, after hip fracture surgery. |
| Ethics approval(s) |
Approved 03/07/2024, Yorkshire & The Humber - Leeds East Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8171, (0)2071048137, (0)207 104 8357; leedseast.rec@hra.nhs.uk), ref: 24/YH/0113 |
| Condition | Mobility in hospital after hip fracture |
| Intervention | INITIATE is a multi-centre, two-arm, unblinded, cluster randomised controlled trial (RCT) with embedded process and economic evaluations. The study will recruit 2310 patients (1155 in each of 2 groups) who have received surgery for a fracture of the hip, from approximately 22 NHS hospitals in the UK. Recruitment centres will be cluster randomised to either Intervention or Control. Recruitment centres will be allocated in a 1:1 ratio using a computer-generated randomisation minimisation sequence. Intervention: Usual care with additional ward-based mobilisation activities. Control: Usual care. Participants will provide data to the research team about their injury and recovery at baseline (during their hospital stay), and then around 30 days and 120 days after their surgery. Follow-up contacts at 30 and 120 days post-surgery will be completed with the participant or a proxy either via telephone interviews by a member of the central research team, or through electronic means. A process evaluation will take place to determine to what extent the cluster RCT protocol is operationalised within the orthopaedic trauma units and determine the extent to which the INITIATE intervention has been delivered per protocol (fidelity) and implemented (adherence). The process evaluation will take place in all intervention sites. |
| Intervention type | Behavioural |
| Primary outcome measure | DAH30 (days alive and at home up to 30 days post-hip fracture surgery) will be measured using participant questionnaires and medical records at 30 days |
| Secondary outcome measures | 1. DAH120 (days alive and at home up to 120 days post-hip fracture surgery) will be measured using participant questionnaires and medical records at 120 days 2. Health-related quality of life will be measured using EQ-5D-5L pre-injury, at 30 days, and 120 days 3. Mobility will be measured using mNMS (modified New Mobility Score) pre-injury and at 30 days 4. Basic mobility at discharge will be measured using CAS (Cumulated Ambulation Score) at discharge 5. Residential status, mortality, rate of complications, rate of falls resulting in fracture or head injury, and resource use will be using participant questionnaires and medical records at 30 days and 120 days 6. The extent to which the cluster RCT protocol is operationalised within the orthopaedic trauma units and the extent to which the INITIATE intervention is adopted and embedded will be measured through intervention analysis and intervention adherence, based on a thematic analysis of interviews with participants (and relative/friend/informal carer as required) and interviews and focus groups with recruitment centre staff during the embedded process and economic evaluations part of the study |
| Overall study start date | 01/04/2024 |
| Overall study end date | 30/11/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 60 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 2310; UK Sample Size: 2310 |
| Participant inclusion criteria | 1. Aged 60 years and over 2. With and without capacity 3. Presenting to a WHITE recruitment centre for treatment of a hip fracture or who has received surgery for a hip fracture in the past 48 hours |
| Participant exclusion criteria | A patient will not be eligible for the study if ANY of the following apply: 1. A fracture caused by an area of abnormal bone (e.g., a tumour) 2. A pre-existing contraindication to mobilising after surgery 3. A patient who had severely limited mobility prior to injury (i.e confined to bed, transfer from bed to chair only) 4. Previous participation in INITIATE or actively engaged in other hip fracture research with contralateral hip fracture |
| Recruitment start date | 01/08/2024 |
| Recruitment end date | 31/12/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Headington
Oxford
OX3 9DU
United Kingdom
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Poplar Grove
Hazel Grove
Stockport
SK2 7JE
United Kingdom
Leicester
LE1 5WW
United Kingdom
Reading
RG1 5AN
United Kingdom
Walsgrave
Coventry
CV2 2DX
United Kingdom
Taunton
TA1 5DA
United Kingdom
Hull
HU3 2JZ
United Kingdom
Tooting
London
SW17 0QT
United Kingdom
Steeton
Keighley
BD20 6TD
United Kingdom
Newcastle upon Tyne
TS1 4LP
United Kingdom
Carlisle
CA2 7HY
United Kingdom
Dryburn Hospital
North Road
Durham
DH1 5TW
United Kingdom
Bordesley Green
Birmingham
B9 5ST
United Kingdom
Sponsor information
Hospital/treatment centre
Research Governance, Ethics & Assurance, Joint Research Office, 1st floor, Boundary Brook House, Churchill Drive, Headington
Oxford
OX3 7GB
England
United Kingdom
| Phone | None provided |
|---|---|
| rgea.sponsor@admin.ox.ac.uk | |
| Website | https://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request. Any requests for data sharing will be submitted to Prof Matt Costa (matthew.costa@ndorms.ox.ac.uk) and Prof Becky Kearney (becky.kearney@bristol.ac.uk) and decided on a case-by-case basis. No data will be released for sharing until after the trial has closed to recruitment and been analysed. |
Editorial Notes
27/01/2025: Hull Royal Infirmary, St Georges Hospital, Airedale General, The Royal Victoria Infirmary, Cumberland Infirmary, University Hospital of North Durham and Heartlands Hospital were added as study participating centres.
24/10/2024: Stockport NHS Foundation Trust, Leicester Royal Infirmary, Royal Berkshire Hospital, University Hospital Coventry & Warwickshire and Musgrove Park Hospital were added as study participating centres.
16/07/2024: Study's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
