Condition category
Injury, Occupational Diseases, Poisoning
Date applied
27/08/2004
Date assigned
11/10/2004
Last edited
17/09/2007
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 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 measures

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

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

Results - basic reporting

Publication summary

Protocol in: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=15651990

Publication citations

  1. 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.

Additional files

Editorial Notes