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 |
| Secondary identifying numbers | 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
Scientific
University Maastricht
Medical Sociology
P.O. Box 616
Maastricht
6200 MD
Netherlands
| j.vaneijk@zw.unimaas.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| 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 | 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 study start date | 01/12/2002 |
| Completion date | 01/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | 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
6200 MD
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Research organisation
Research organisation
Laan van Nieuw Oost Indië 334
P.O. Box 93245
The Hague
2509 AE
Netherlands
| Phone | +31 (0)70 349 5111 |
|---|---|
| info@zonmw.nl | |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) (ref: 945-02-053)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 14/01/2005 | Yes | No | |
| Other publications | process evaluation | 24/09/2008 | 26/02/2021 | Yes | No |
| Results article | results | 01/03/2008 | 26/02/2021 | Yes | No |
Editorial Notes
26/02/2021: Publication references added.
