Condition category
Injury, Occupational Diseases, Poisoning
Date applied
16/06/2008
Date assigned
09/10/2008
Last edited
09/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Yngve Gustafson

ORCID ID

Contact details

Umeå University
Geriatric Medicine
Umeå
SE-901 87
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Home rehabilitation for older people with hip fracture - a randomised controlled trial

Acronym

Study hypothesis

Multidisciplinary home rehabilitation is applicable and effective as conventional rehabilitation at hospital.

Ethics approval

Ethics Committee of the Faculty of Medicine at Umea University. Date of approval 01/04/2008 (ref: Dnr 08-053M)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

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 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

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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)

Overall trial start date

01/08/2008

Overall trial end date

01/08/2010

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

200

Participant exclusion criteria

No exclusion criteria

Recruitment start date

01/08/2008

Recruitment end date

01/08/2010

Locations

Countries of recruitment

Sweden

Trial participating centre

Umeå University
Umeå
SE-901 87
Sweden

Sponsor information

Organisation

Umeå University (Sweden)

Sponsor details

-
Umeå
SE-901 87
Sweden

Sponsor type

University/education

Website

http://www.umu.se/umu/index_eng.html

Funders

Funder type

University/education

Funder name

University of Umeå (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

County Council of Västerbotten (Sweden)

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes