Evaluation of home rehabilitation for hip fracture patients

ISRCTN	ISRCTN15738119
DOI	https://doi.org/10.1186/ISRCTN15738119
Protocol serial number	N/A
Sponsor	Umeå University (Sweden)
Funders	University of Umeå (Sweden), County Council of Västerbotten (Sweden)

Submission date: 16/06/2008
Registration date: 09/10/2008
Last edited: 10/03/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Yngve Gustafson
Scientific

Umeå University
Geriatric Medicine
Umeå
SE-901 87
Sweden

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Home rehabilitation for older people with hip fracture - a randomised controlled trial
Study objectives	Multidisciplinary home rehabilitation is applicable and effective as conventional rehabilitation at hospital.
Ethics approval(s)	Ethics Committee of the Faculty of Medicine at Umea University. Date of approval 01/04/2008 (ref: Dnr 08-053M)
Health condition(s) or problem(s) studied	Rehabilitation for hip fracture patients
Intervention	Multidisciplinary home rehabilitation compared to conventional multidisciplinary rehabilitation at hospital with follow-ups at 12 weeks after randomisation and 12 months after surgery. Those randomised to control group will be at hospital as long as necessary and those randomised to intervention/experimental group have home rehabilitation as long as necessary but not longer than 10 weeks. Both groups will have comprehensive geriatric assessments, management and rehabilitation with active prevention, detection and treatment of postoperative complications such as falls, delirium, pain and infections, for example. Those randomised to home rehabilitation will receive some of these assessments and rehabilitation at home.
Intervention type	Other
Primary outcome measure(s)	1. In-patient days and re-admissions, followed-up until 12 months post-surgery 2. Complications, for example falls and injuries, followed-up until 12 months post-surgery 3. Depression, assessed by the Geriatric Depression Scale (GDS) followed-up until 12 months post-surgery 4. Delirium, assessed by the Organic Brain Syndrome Scale followed-up until 12 months post-surgery 5. Functional performance regarding activities of daily living (ADL), assessed by the Katz ADL index and Barthel ADL index, at 12 weeks post-randomisation and 12 months post-surgery 6. Walking ability and use of walking aids, assessed by the Swedish version of the Clinical Outcome Variable Scale (S-COVS) at 12 weeks post-randomisation and 12 months post-surgery
Key secondary outcome measure(s)	The following will be assessed at 12 weeks post-randomisation and 12 months post-surgery: 1. Balance, assessed by the Bergs Balance Scale and Fear of Falling 2. Quality of life, assessed by EQ-5D 3. Nutritional status, assessed by the mini nutritional assessment (MNA) 4. Costs 5. Self-perceived health, assessed by the 36-item Short Form (SF-36) health survey 6. Pain, assessed by a visual analogue scale (VAS) 7. Subjective well-being, assessed by the Philadelphia Geriatric Morale Scale (PGCM)
Completion date	01/08/2010

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	200
Total final enrolment	205
Key inclusion criteria	1. Both males and females, 70 years and above 2. Hip fracture patients after surgery 3. Those who live in the municipality of Umeå (both independent living and from institutions)
Key exclusion criteria	No exclusion criteria
Date of first enrolment	01/08/2008
Date of final enrolment	01/08/2010

Locations

Countries of recruitment

Sweden

Study participating centre

Umeå University

Umeå
SE-901 87
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		04/09/2020	10/03/2023	Yes	No
Results article		09/03/2023	10/03/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/03/2023: Publication references and total final enrolment added.