Condition category
Injury, Occupational Diseases, Poisoning
Date applied
11/08/2005
Date assigned
01/09/2005
Last edited
19/02/2008
Prospective/Retrospective
Prospectively 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

Dr Gabriele Meyer

ORCID ID

Contact details

University of Hamburg
Unit of Health Sciences and Education
Martin-Luther-King-Platz 6
Hamburg
D-20146
Germany
+49 (0)4042 838 7230
gabriele.meyer@uni-hamburg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01GT0306

Study information

Scientific title

Acronym

PROF

Study hypothesis

To determine if the administration of a fall risk assessment tool reduces the number of fallers.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

Frail elderly

Intervention

Education session for all clusters to optimise standard care and to minimise centre effects.
Intervention group: Optimised standard care, administration of a standard fall risk assessment tool (Downton Index) alongside nurses' clinical judgement
Control group: Optimised standard care with nurses' clinical judgement alone

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Number of participants with at least one fall at 12 months.

Secondary outcome measures

1. Number of falls
2. Clinical consequences, i.e., fall and injury prevention measures applied
3. Side effects, i.e., use of restraints

Other:
1. Injuries and fractures related to falls
2. Hospital admissions and consultations with a physician due to falls
3. Costs

Overall trial start date

01/09/2005

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Cluster (nursing home by itself or an independently working ward of a large nursing home):
1. At least 30 residents

Residents:
2. 70 years or older
3. Not bedridden
4. Living in the nursing home for more than three months

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

1080

Participant exclusion criteria

Cluster:
1. Less than 30 residents

Residents:
2. 69 years or younger
3. Living in the nursing home for less than three months
4. Bedridden

Recruitment start date

01/09/2005

Recruitment end date

31/03/2007

Locations

Countries of recruitment

Germany

Trial participating centre

University of Hamburg
Hamburg
D-20146
Germany

Sponsor information

Organisation

University of Hamburg (Germany)

Sponsor details

Unit of Health Sciences and Education
Martin-Luther-King-Platz 6
Hamburg
D-20146
Germany
+49 (0)4042 838 7230
gabriele.meyer@uni-hamburg.de

Sponsor type

University/education

Website

http://www.chemie.uni-hamburg.de/igtw/Gesundheit/gesundheit.htm

Funders

Funder type

Government

Funder name

German Ministry of Education and Research (Germany) - within the Northern Germany Nursing Research Network

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

Protocol in http://www.ncbi.nlm.nih.gov/pubmed/16285880

Publication citations

  1. Protocol

    Meyer G, Köpke S, Bender R, Mühlhauser I, Predicting the risk of falling--efficacy of a risk assessment tool compared to nurses' judgement: a cluster-randomised controlled trial [ISRCTN37794278]., BMC Geriatr, 2005, 5, 14, doi: 10.1186/1471-2318-5-14.

Additional files

Editorial Notes