Predicting the Risk Of Falling - efficacy of a risk assessment tool compared to nurses' judgement: a cluster-randomised controlled trial

ISRCTN	ISRCTN37794278
DOI	https://doi.org/10.1186/ISRCTN37794278
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	01GT0306
Sponsor	University of Hamburg (Germany)
Funder	German Ministry of Education and Research (Germany) - within the Northern Germany Nursing Research Network

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Gabriele Meyer
Scientific

University of Hamburg
Unit of Health Sciences and Education
Martin-Luther-King-Platz 6
Hamburg
D-20146
Germany

Phone	+49 (0)4042 838 7230
Email	gabriele.meyer@uni-hamburg.de

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Predicting the Risk Of Falling - efficacy of a risk assessment tool compared to nurses' judgement: a cluster-randomised controlled trial
Study acronym	PROF
Study objectives	To determine if the administration of a fall risk assessment tool reduces the number of fallers.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Number of participants with at least one fall at 12 months.
Key secondary outcome measure(s)	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
Completion date	31/03/2007

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	1080
Total final enrolment	1125
Key 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
Key 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
Date of first enrolment	01/09/2005
Date of final enrolment	31/03/2007

University of Hamburg

Hamburg
D-20146
Germany

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2009	31/05/2019	Yes	No
Protocol article	protocol	10/11/2005		Yes	No

31/05/2019: Publication reference and total final enrolment added.