INITIATE: Increased mobility in hospital after hip fracture

Registry ID
ISRCTN13661431
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
University of Oxford
Enrollment
2310
Start date
2024-08-01
Completion date
2027-09-30
Last update
2026-08-17

Conditions

Summary

Mobility in hospital after hip fracture

Detailed description

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.

Interventions

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

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

Locations

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