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FIT-study.


- candidate number8779
- NTR NumberNTR2653
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-dec-2010
- Secondary IDs10/182  MEC Academic Medical Center Amsterdam - University of Amsterdam
- Public TitleFIT-study.
- Scientific TitleMaintaining Functionality in Transition.
- ACRONYMFIT
- hypothesisIn old age, reduction in physical function leads to loss of independence, the need for hospital and long-term nursing-home care, and premature death.
Community-based complex interventions can be effective in maintaining physical function and independence in elderly people.
- Healt Condition(s) or Problem(s) studiedFrailty, Geriatric assessment, Public health nursing, Activities of daily living, Family practice/general practice
- Inclusion criteriaPhase 1 (general screening):
1. Patients aged 70 years and older.

Phase 2 (intervention):
1. An increased risk for functional decline, defined as a score of two or more on the ISAR-PC screening instrument;
2. Speaks and understands Dutch;
3. Patient is registered with a GP.
- Exclusion criteria1. Terminal illness;
2. Dementia;
3. Does not speak or understand Dutch;
4. Living in a nursing home.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2010
- planned closingdate1-jul-2013
- Target number of participants1418
- InterventionsA nurse-led comprehensive geriatric assessment (CGA) in patients at increased risk for functional decline (2 or more points on the ISAR-PC score), a tailor-made care and treatment plan, and seven follow-up contacts during one year.
- Primary outcomeThe level of (instrumental) activities of daily living, measured with the modified Katz ADL (15) index score.
- Secondary outcome1. Hospital and nursing home admissions;
2. Self-reported health care utilization;
3. Quality of life (EQ-6D);
4. Overall mortality.
- TimepointsPrimary endpoint at 12 months, secondary endpoints at 6, 12, 18 and 24 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. S.E.J.A. Rooij, de
- CONTACT for SCIENTIFIC QUERIESDr. E.P. Moll van Charante
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryBackground:
In old age, reduction in physical function leads to loss of independence, the need for hospital and long-term nursing-home care, and premature death.
Community-based complex interventions can be effective in maintaining physical function and independence in elderly people.

Study design:
A multicenter, cluster randomized clinical trial at the level of the General Practitioner (GP) comparing a pro-active, multi-component (multidisciplinary and multidimensional) intervention, coordinated by a Health Care Nurse (HCN) specialized in elderly care with care as usual.

Study population:
Community-dwelling elderly people 70 years and older with an increased risk for functional decline.

Intervention:
First, all eligible elderly people who are registered with their GP will be sent a postal questionnaire, the Identification of Seniors at Risk in Primary Care (ISAR-PC), that was developed during a pilot study. In half of the GP practices, patients with increased risk for functional decline will be invited to receive a nurse-led comprehensive geriatric assessment (CGA). In the CGA, participants will be screened for over 30 conditions on four domains (physical, functional, mental, social functioning) that are most prevalent among elderly people. The targeted problems are part of an evidence based protocol (‘toolkit’) that was developed in the Defence-study (www.defencestudy.nl) and further extended in a pilot phase of the FIT-study, and yields a care and treatment plan that is discussed with both patient and GP. When consensus is reached on the intervention, the HCN will coordinate all care and treatment contacts and will frequently see all participating elderly in the office or at home to monitor the effects of all interventions.

Main study parameters/endpoints:
The main outcome is the the level of (instrumental) activities of daily living, measured with the modified Katz ADL index score. Secondary outcomes include hospital and nursing home admissions, self-reported health care utilization and quality of life (EQ-6D) and overall mortality.
- Main changes (audit trail)
- RECORD17-dec-2010 - 11-jan-2011


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