Preventing further falls and functional decline among elderly persons presented to the Accident and Emergency (A&E) department with a fall: randomised controlled trial

ISRCTN	ISRCTN64716113
DOI	https://doi.org/10.1186/ISRCTN64716113
Protocol serial number	945-02-053
Sponsor	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 945-02-053)

Submission date: 27/08/2004
Registration date: 11/10/2004
Last edited: 02/09/2021

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 Jacques van Eijk
Scientific

University Maastricht
Medical Sociology
P.O. Box 616
Maastricht
6200 MD
Netherlands

Email	j.vaneijk@zw.unimaas.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Preventing further falls and functional decline among elderly persons presented to the Accident and Emergency (A&E) department with a fall: randomised controlled trial
Study acronym	Interval
Study objectives	The main objective of our current study is to evaluate the effects of a multidisciplinary intervention programme on recurrent falls and functional decline among elderly persons who have visit a general practitioners' cooperative (GP cooperative) and/or an accident and emergency department (A&E department) because of a fall. This objective has resulted in the following research questions: 1. Is a multidisciplinary intervention programme more effective than usual care in preventing new falls and functional decline among community-dwelling elderly people who visit a GP cooperative and/or A&E department at a hospital because of a fall? 2. Is the multidisciplinary intervention programme cost-effective compared to usual care when assessed from a societal perspective?
Ethics approval(s)	The study design and protocols were approved by the Medical Ethics Committee of the University Hospital and University of Maastricht.
Health condition(s) or problem(s) studied	Falls
Intervention	1. Patients in the intervention group underwent a detailed medical and occupational-therapy assessment with referral to relevant services if indicated 2. Those assigned to the control group received usual care only
Intervention type	Other
Primary outcome measure(s)	1. Number of falls (recorded continuously by means of a fall calendar during the twelve-month follow-up period): 1.1. The percentage of elderly people sustaining a fall during the one-year follow-up period 1.2. Recurrent falls during follow-up (i.e., the percentage of elderly people sustaining two or more falls) 1.3. Injurious falls during follow-up (the percentage of elderly people receiving medical care after a fall) 2. Daily functioning, measured using the Frenchai Activity Index (FAI) at baseline and after four and twelve months
Key secondary outcome measure(s)	Secondary outcome measures: 1. Recuperation from the fall 2. Health complaints 3. Perceived health measured by means of the first two items of the RAND 36-Item Health Survey 4. Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) disability measured by means of the Groningen Activity Restriction Scale (GARS) 5. Mental health measured by means of the Hospital Anxiety and Depression Scale (HADS) 6. Quality of life measured by means of the European Quality of Life instrument (EuroQol) The secondary outcome measures are assessed by means of self-administered questionnaires at four and twelve months.
Completion date	01/02/2004

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target sample size at registration	328
Key inclusion criteria	1. Aged 65 years or older 2. Community-dwelling 3. Having visited the A&E department or GP cooperative at the University Hospital Maastricht with consequences resulting from a fall 4. Living in Maastricht or its surroundings
Key exclusion criteria	1. Not able to speak or understand Dutch 2. Not able to complete questionnaires or interviews by telephone 3. Cognitive impairment (a score of less than 4 on the Abbreviated Mental Test 4 (AMT 4) 4. Long-term admission to a hospital or other institution (more than four weeks from the date of inclusion) 5. Permanently bedridden 6. Fully dependent on a wheelchair
Date of first enrolment	01/12/2002
Date of final enrolment	01/02/2004

Locations

Countries of recruitment

Netherlands

Study participating centre

University Maastricht

Maastricht
6200 MD
Netherlands

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2008	26/02/2021	Yes	No
Protocol article	Protocol	14/01/2005		Yes	No
Other publications	process evaluation	24/09/2008	26/02/2021	Yes	No

Editorial Notes

26/02/2021: Publication references added.