Contact information
Type
Scientific
Primary contact
Prof Jacques van Eijk
ORCID ID
Contact details
University Maastricht
Medical Sociology
P.O. Box 616
Maastricht
6200 MD
Netherlands
j.vaneijk@zw.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
945-02-053
Study information
Scientific title
Acronym
Interval
Study hypothesis
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
The study design and protocols were approved by the Medical Ethics Committee of the University Hospital and University of Maastricht.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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
Secondary outcome measures
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.
Overall trial start date
01/12/2002
Overall trial end date
01/02/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
328
Participant 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
Recruitment start date
01/12/2002
Recruitment end date
01/02/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Maastricht
Maastricht
6200 MD
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Sponsor details
Laan van Nieuw Oost Indië 334
P.O. Box 93245
The Hague
2509 AE
Netherlands
+31 (0)70 349 5111
info@zonmw.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 945-02-053)
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
Basic results (scientific)
Publication list
Protocol in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15651990
Publication citations
-
Protocol
Hendriks MR, van Haastregt JC, Diederiks JP, Evers SM, Crebolder HF, van Eijk JT, Effectiveness and cost-effectiveness of a multidisciplinary intervention programme to prevent new falls and functional decline among elderly persons at risk: design of a replicated randomised controlled trial [ISRCTN64716113]., BMC Public Health, 2005, 5, 6, doi: 10.1186/1471-2458-5-6.