Condition category
Musculoskeletal Diseases
Date applied
10/07/2014
Date assigned
21/07/2014
Last edited
09/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hip fracture is a common, major health problem in old age. It is strongly associated with other health problems, under-nutrition, weakness, and poor physical and mental functioning. The death rate is high with 25% dying within the following 12 months. Many who were living independently before their fracture lose their independence afterwards, so it imposes a large cost burden on society amounting to about £2 billion a year. As the population ages the numbers of elderly people falling and fracturing their hips is increasing. As well as prompt surgical treatment the guidelines recommend that the associated medical needs are assessed promptly by a physician specialised in caring for such patients, who can also devise a multidisciplinary rehabilitation. Such rehabilitation starts whilst in hospital during the recovery period after the operation and continues in the community following hospital discharge. Multidisciplinary rehabilitation is thought to aid in recovery after a hip fracture, but more research is needed. In the first phase of the study we developed a rehabilitation programme from examples of good practice from a national survey and from what patients, their carers and rehabilitation staff told us in focus group interviews. We are now conducting a small-scale study to find out whether enough people are willing to take part, whether the intervention can be run, whether we can collect the necessary information, and how people feel about taking part and their views of the intervention.

Who can participate?
Adults aged 65 years or older who have recently had a hip fracture and had undergone surgery can take part.

What does the study involve?
The study involves agreeing to answer questions on your health and how your hip fracture has affected how you function in daily life, how you use health and social services, and also some tests of physical function such as your hand grip strength, and after 3 months how well you can get up out of a chair and walk. Participants will be randomly allocated to receive either the usual rehabilitation available or a different programme of rehabilitation.

What are the possible benefits and risks of participating?
The advantages are that taking part in a study such as this can give additional benefits to people in whichever group they are in. We do not anticipate any disadvantage from participating as both groups will receive a programme of rehabilitation.

Where is the study run from?
The study is run from the three acute hospitals in North Wales, UK (Betsi Cadwaladr University Health Board): Gwynedd Hospital (Ysbyty Gwynedd), Glan Clwyd Hospital (Ysbyty Glan Clwyd) and Wrexham Maelor Hospital (Ysbyty Wrecsam Maelor).

When is the study starting and how long is it expected to run for?
The study started in June 2014 and is expected to run until April 2015.

Who is funding the study?
National Institute for Health Research (NIHR) (UK) - Health Technology Assessment (HTA).

Who is the main contact?
Dr Nefyn Williams
nefyn.williams@bangor.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nefyn Williams

ORCID ID

Contact details

North Wales Organisation for Randomised Trials in Health (& Social Care)
Bangor University
Y Wern
Normal Site
Holyhead Road
Bangor
LL57 2PZ
United Kingdom
-
nefyn.williams@bangor.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 11/33/03

Study information

Scientific title

Developing a multidisciplinary rehabilitation package following hip fracture

Acronym

FEMuR

Study hypothesis

1. To assess the acceptability of and compliance with the rehabilitation programme amongst patients, carers and clinicians and identification of any adverse events. To assess the feasibility of a future definitive RCT by assessing the number of eligible patients, monitoring recruitment and retention rates, and explore the willingness of patient participants to be randomised and the willingness of patients and carers to complete outcome measures. To produce means and standard deviations of the quantitative measures so that effect sizes can be calculated for planning the future RCT.
2. To explore the methodological issues for an economic evaluation alongside a future RCT including the most efficient way of measuring patient level costs and health benefits, programme costs, and potential payer stakeholders.
3. To explore the feasibility and quality of data on service use extracted from patient electronic records compared with patient-reported outcome measures. If successful, replacing patient-reported outcomes of service use with data collection by researchers and NHS IT staff for electronic records has potential to reduce participant burden in future studies.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/113303
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0018/81153/PRO-11-33-03.pdf

Ethics approval

UK NHS Ethics Committee - Wales REC 5, ref: 13/WA/0402

Study design

Randomised feasibility study with embedded cohort

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Rehabilitation for people aged 65 and over following surgery for fractured neck of femur

Intervention

Participants are randomised to two groups:

1. Intervention group: A rehabilitation intervention consisting of a workbook and goal setting diary to be held and used by the patient collaboratively with their rehabilitation therapist. In addition to usual care patients will receive six extra sessions of supervised physiotherapy or occupational therapy rehabilitation, tailored to their individual needs

2. Control group: Usual rehabilation care available

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Barthel Index measured at baseline and at 3 months

Secondary outcome measures

1. Abbreviated Mental Test Score (AMTS)
2. Nottingham Extended Activities of Daily Living Scale
3. Hospital Anxiety and Depression Scale (HADS)

Measured at baseline and at 3 months.

Process outcomes:
1. Visual Analogue Scale (VAS) for hip pain intensity
2. General Self Efficacy Sale
3. Falls Efficacy Scale - International (FES- I)
4. Self-efficacy for exercise scale
5. Visual Analogue Score - Fear of Falling (VAS-FOF)

Health economic measures:
1. EuroQol EQ-5D
2. ICEpop CAPability measure for Older people (ICECAP-O)
3. Client Service Receipt Inventory (CSRI)
4. Discrete Choice Experiment

Objective Measures of Physical Function:
1. Grip strength
2. Thirty second sit to stand
3. Eight foot get up and go test

Fifty foot walk test:
Cohort-study outcomes include: number of patients aged over 65 years admitted with a proximal femoral fracture; the number who fulfil the inclusion criteria for the randomised feasibility study; the number of deaths, serious complications such as falls and repeat fractures, serious illness requiring hospital re-admission and discharged to institutional care (including detail such as the type of ward and the type of residential care)

Overall trial start date

09/06/2014

Overall trial end date

30/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 65 years or older
2. Recent proximal hip fracture including the following types of fracture: intracapsular, extracapsular (pertrochanteric, intertrochanteric, reverseoblique or subtrochanteric)
3. Surgical repair by replacement arthroplasty or internal fixation within the previous week; recovering as an in-patient on an orthopaedic ward and not yet discharged home or transferred to an in-patient unit
4. Living independently prior to hip fracture, defined as living in their own home
5. Capacity to give informed consent
6. Living and receiving rehabilitation in the participating NHS site area
7. Carers of patient participants will also be recruited where they provide them with face to face support most days in a week including help with activities of daily living and or physical care

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

90 patient participants plus any of their carers recruited

Participant exclusion criteria

1. Younger adults with hip fracture
2. Non-surgical treatment following hip fracture
3. Living in residential or nursing homes prior to hip fracture
4. Lack of capacity to give informed consent
5. Participants who are not able to understand Welsh or English
6. Participants who do not live and will not receive community rehabilitation in the participating NHS site area

Recruitment start date

09/06/2014

Recruitment end date

30/04/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North Wales Organisation for Randomised Trials in Health (& Social Care)
Bangor
LL57 2PZ
United Kingdom

Sponsor information

Organisation

Bangor University (UK)

Sponsor details

c/o Bob Woods
Professor of Clinical Psychology of the Elderly
DSDC Wales
Ardudwy
Holyhead Road
Bangor
LL57 2PX
United Kingdom

Sponsor type

University/education

Website

http://Bangor.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Health Technology Assessment Programme - HTA

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

01/11/2015

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.pilotfeasibilitystudies.com/content/1/1/13/abstract

Publication citations

Additional files

Editorial Notes