Mobility in hospital after hip fracture Musculoskeletal Diseases
Conditions
Interventions
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
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
60 Years to 110 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactGratian Vandici
Outcome results
None listed