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van CCT (UK)

van CCT (UK)

Better in-Better out.

- candidate number8701
- NTR NumberNTR2618
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-nov-2010
- Secondary IDs60-61900-98-280 ZonMW/NPO
- Public TitleBetter in-Better out.
- Scientific TitleRandomized Clinical Trial on peri-operative interventions for fragile older patients undergoing surgery, The Profyd trial.
- hypothesisPeri-operative interventions improve fragile patients functional health status, reduce complications and length of stay in hospital after elective surgery.
- Healt Condition(s) or Problem(s) studiedMultimorbidity, Fragility, Post-operative complications, Preventive and screening intervention
- Inclusion criteriaFragile, community-dwelling elderly, 70 years and older, who are on a waiting list for abdominal or thoracal surgery.
- Exclusion criteriaEndoscopic and gynaecological operations.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate1-jan-2012
- Target number of participants77500
- InterventionsPeri-operative tailormade intervention aims at:
1. Optimizing physical condition by preoperative functional trainingprogramm by a physiotherapist, 2/3 times a week at the clients home;
2. Preoperative nutritional status assessment and optimalisation by a dietician, counseling once a week;
3. Reducing risk factors for delirium by a geriatric specialist;
4. Prescribing Optimalization Method for optimalization of medication use by a geritric specialist;
5. Organizing postoperative home care.
Minimal duration of the intervention is 3 weeks.

The control group receives care as usual. That means no peri-operative intervention
- Primary outcomeLength of hospital stay and postoperative complications.
- Secondary outcome1. Quality of life;
2. Functional status;
3. Nutrition status (Malnutrition Universal Screening Tool (MUST));
4. Participation.
These secondary outcomes will be measured with a questionnaire for the patient, the medical file and registration forms of involved care professionals.
- TimepointsT0 Baseline measurement: Before randomization;
T1 On hospital admission;
T2 Short term measurement: 30 days after the operation;
T3 Long term measurement: 6 months after operation.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Catharina Hospital Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryHospital admission can be a major life event for fragile older people, associated with increased morbidity and mortality. Especially, large invasive surgical interventions are in elderly patients increasingly accompanied with complications, delirium, loss of function and mortality. To decease post-surgical complications in fragile older patients indicated for elective surgery a pre-surgical multidisciplinary intervention was designed in order to increase the older patients' physical and mental condition before surgery and to prevent them from complications and loss of indenpendency after surgery. The cost-effectiveness of the intervention is tested in a randomized clinical trial. The control group receives the care as usual. Primary outcome is complications after surgery and length of stay in hospital. Secondary outcome focusses on physical functioning, quality of life, and level of independency. To show effectiveness it was calculated that 40 patients should be included in the intervention arm and 40 in the control-arm.
- Main changes (audit trail)
- RECORD24-nov-2010 - 8-dec-2010

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