Structured Tailored Rehabilitation After Hip Fragility Fracture

NCT06014554 | Recruiting DMC

• 1 other identifier: 312631
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Why the investigators are doing this study? The best approach to rehabilitation after a broken hip is not known. A new approach could improve outcomes by tailoring rehabilitation to patient needs. This approach identifies subgroups of patients within a population who have different risks of poor outcomes. These subgroups are then matched to treatments better tailored to their needs. Survivors of a broken hip describe a tailored approach as key to recovery. Further, the NHS recommends this approach as central to healthcare progress. This study wants to see if it is possible for the NHS to deliver this new approach to rehabilitation for older adults who break their hip. What will be done? The investigators worked with patients to plan this study. Patients will keep helping the investigators during the study. Sixty older people who had surgery to fix a broken hip will be invited to take part. Participants will be given a level of risk (low, medium, or high) based on an online calculator (www.stratifyhip.co.uk). All 60 participants will get usual care provided locally. Half, selected by chance, will get extra rehabilitation during their hospital stay including a self-managed exercise programme for the low-risk subgroup, education, a goal-orientated mobility programme and enhanced discharge planning for the medium-risk subgroup, and education, a goal-orientated activity of daily living programme, orientation, and enhanced assessment for the high-risk subgroup. The investigators will collect information from the 60 people taking part, at the beginning, middle, and end of the study and again 12- weeks later. What will the next step be? If this small study shows this extra rehabilitation can be provided in the NHS, and it may help patients, then the investigators plan to do a larger study. The larger study will see if this extra rehabilitation works to help older people get back home and feel happier.

Conditions

Hip Fractures

Keywords

neck of femur; fragility fracture; rehabilitation; stratified care

Outcome Measures

Primary Outcomes (2)

• Treatment fidelity (supervised intervention)

  measured through assessment of treatment logs

  At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)

• Treatment fidelity (unsupervised intervention)

  measured through assessment of patient diary

  At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)

Secondary Outcomes (17)

• Count of screened, eligibly, approached, recruited and retained participants

  screening through to 12-week follow-up

• Acceptability of intervention to participants, carers and therapists

  At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)

• Barriers and enablers to intervention delivery

  At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)

• Acceptability and completeness of EuroQoL EQ-5D-5L

  Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up

• Acceptability and completeness of Barthel Index

  Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up

Study Arms (2)

Stratify

EXPERIMENTAL

Patients randomised to the 'Stratify' intervention will receive usual care and an intervention based on their subgroup assignment. The intervention will start before the third postoperative day and be delivered during the inpatient stay. Intervention components will be delivered by a physiotherapist, occupational therapist, or therapy assistant depending on staffing availability.

Other: Low-risk subgroup; Other: Medium-risk subgroup; Other: High-risk subgroup

Usual care

PLACEBO COMPARATOR

Patients randomised to the control arm will receive usual physiotherapy and occupational therapy care.

Other: Control group

Interventions

Low-risk subgroup OTHER

Self-managed exercise programme.

Stratify

Medium-risk subgroup OTHER

Education, goal-orientated mobility programme, and enhanced discharge planning.

Stratify

High-risk subgroup OTHER

Education, enhanced assessment, orientation, and goal-orientated activities of daily living training programme.

Stratify

Control group OTHER

Usual care entails physiotherapy and occupational therapy from the day after surgery to the point of discharge, with a focus on discharge planning and sufficient recovery of activities of daily living and mobility for safe return to prefracture residence.

Usual care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 60 years or more.
• admitted to hospital for surgical repair of a hip fracture.
• who are willing and able to provide consent or assent depending on the level of cognitive impairment.

You may not qualify if:

• less than 60 years, to align with the National Hip Fracture Databases definition of the target population.
• not surgically treated, as this treatment approach is reserved for around 2% of patients in the UK who are often at the end of life.
• who broke their hip in hospital following admission for a different illness/injury as their anticipated care pathway and outcomes will vary from those who are admitted for hip fracture.
• participating in other treatment trials and without agreement of both trial teams.

Sponsors & Collaborators

• King's College London: lead
• UK Research and Innovation: collaborator

Study Sites (1)

St Thomas Hospital

London, United Kingdom

RECRUITING

Related Publications (1)

• Sheehan KJ, Guerra S, Ayis S, Goubar A, Foster NE, Martin FC, Godfrey E, Cameron ID, Gregson CL, Walsh NE, Ferguson Montague A, Edwards R, Adams J, Jones GD, Gibson J, Sackley C, Whitney J. Structured tailored rehabilitation after hip fragility fracture: The 'Stratify' feasibility and pilot randomised controlled trial protocol. PLoS One. 2024 Dec 17;19(12):e0306870. doi: 10.1371/journal.pone.0306870. eCollection 2024.

  PMID: 39689129 DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Katie J Sheehan, PhD

CONTACT

+44 (0)20 7123 4843; katie.sheehan@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 28, 2023
• Study Start: April 15, 2024
• Primary Completion: January 30, 2025
• Study Completion: June 1, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Following publication of the primary paper, an anonymised dataset will be preserved indefinitely on the King's Open Research Data System.
• Access Criteria: Proof of ethical approval as a condition of access.

Locations

GB (1)