|- candidate number||21185|
|- NTR Number||NTR5015|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-dec-2014|
|- Secondary IDs||P14-31 |
|- Public Title||Prevention of falling|
|- Scientific Title||Randomized controlled intervention trial on falling and functional decline in the hospitalized elderly|
|- hypothesis||With a daily activity programme concerning activities of daily life with occupational therapy by volunteers , physiotherapy and ergotherapy , probably functional decline does not develop or the condition of the patients can improve and it can reduce the falling incidence in hospital|
|- Healt Condition(s) or Problem(s) studied||Falling, Functional decline, Older adults, Prevention|
|- Inclusion criteria||- agreement by the attending doctor;|
- patients >70 year;
- stay in hospital > 3 days;c
- informed consent;
- ability to read and write Dutch.
|- Exclusion criteria||- patients in isolation precautions;|
- patients who can not go to the room
where the activity programme is given;
- patients participating in another study.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||Single arm|
|- planned startdate ||5-jan-2015|
|- planned closingdate||5-jan-2017|
|- Target number of participants||496|
|- Interventions||A daily two hours activities of daily life programme with occupational therapy by volunteers , physiotherapy and ergotherapy to improve the physical and mental condition.|
|- Primary outcome||lncidence of falling and functional decline.|
|- Secondary outcome||lncidence of risk on functional decline and quality of life.|
|- Timepoints||- at admission to the hospital|
- at discharge from the hospital
- 3 months after discharge from the hospital
|- Trial web site||-|
|- CONTACT FOR PUBLIC QUERIES||Verpleegkundig onderzoeker Sandra Koster|
|- CONTACT for SCIENTIFIC QUERIES|| |
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|Medisch Spectrum Twente|
|- Publications||The results of the sudy will be published|
|- Brief summary||Background of the study:|
Over 25% of hospitalized patients is >70 years (400.000 patients a year in the Netherlands ).A hospita! stay in elderly is associated with complications like an infection, malnutrition , delirium, decubitus or a fall. 30-60% of these patients develop functional decline. About 30-60% of the older patients develop new dependence in activities of daily living (ADL) during a hospital stay, which results in progressive disability after discharge.
Objective of the study:
With a daily activity programme concerning activities of daily life with occupational therapy by volunteers , physiotherapy and ergotherapy , probably functional decline does not develop or the condition of the patients can improve and it can reduce the falling incidence in hospital.
With a randomized controlled intervention trial, investigating if and in what way a dailyactivity programme in hospitalized elderly 70 years, based on the physical and cognitive condition, can reduce the fall incidence in hospital and how it influences functional decline.
496 patients >70 years in Medisch Spectrum Twente in the following wards : internal medicine and cardiology. The intervention group follows a daily activity programme and the intervention group receives the regular care.
A daily two hours activities of daily life program me with occupational therapy by volunteers , physiotherapy and ergotherapy to improve the physical and mental condition.
|- Main changes (audit trail)|
|- RECORD||22-dec-2014 - 11-apr-2015|