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Randomised controlled trial to evaluate the effects of tele-monitoring weight in oncology and COPD patients.


- candidate number10152
- NTR NumberNTR2995
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jul-2011
- Secondary IDsNL36151.072.11  METC
- Public TitleRandomised controlled trial to evaluate the effects of tele-monitoring weight in oncology and COPD patients.
- Scientific TitleRandomised controlled trial to evaluate the effects of tele-monitoring weight in oncology and COPD patients.
- ACRONYMView on Weight
- hypothesisThe objective of this study is to investigate if monitoring weight by tele-monitoring and its procedure in oncology and COPD patients results in less weight loss (or in weight gain), compared to the control group.
To evaluate if monitoring weight by tele-monitoring and its procedure in oncology and COPD patients, results in a higher compliance of sip feed intake and a lower incidence of infections and/or complications, compared to the control group.
- Healt Condition(s) or Problem(s) studiedCancer, Complications, Infection, COPD, Weight, Malnutrition
- Inclusion criteria1. Male or female adult ≥ 18 years of age;
2. Oncology or COPD patient;
3. Risk of malnutrition (assessed by the screening tools MUST or SNAQ);
4. Subject is prescribed sip feed at home for at least 3 months;
5. Written informed consent from subject.
- Exclusion criteria1. Life expectancy < 6 months;
2. Subject who is frequently seen by a dietician (≥ 3 times/month);
3. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
4. Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry the study.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2011
- planned closingdate1-jul-2012
- Target number of participants168
- InterventionsDuring the study, subjects in the intervention group will be monitored by tele-monitoring and measure their weight twice a week. If a patient has lost weight, the dietician will contact the patient.
The control group will receive care as usual.
- Primary outcomeWeight [kg].
- Secondary outcome1. Sip feed intake [ml/day, % of prescribed];
2. Number of infections [-];
3. Number of complications [-];
4. Unplanned hospitalisations [-].
- TimepointsWeight:
Intervention: Recorded twice a week throughout whole study period.
Control: Recorded at baseline and every 3 weeks.

Infections, complications, unplanned hospitalisations:
Recorded every 3 weeks in both study groups.

Sip feed intake:
Recorded every 3 weeks in both study groups.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Claire Hoogerwerf
- CONTACT for SCIENTIFIC QUERIES Maaike Jager, de
- Sponsor/Initiator Medizorg, Abbott Nutrition, Nutricia Netherlands
- Funding
(Source(s) of Monetary or Material Support)
Abbott Nutrition, Medizorg BV, Nutricia Netherlands
- PublicationsN/A
- Brief summaryMany oncology and COPD patients are at risk of malnutrition. Malnutrition results in an increased risk of infections and post-operative complications, an impaired response on chemotherapy an increased length of hospital stay, shortage of lean body mass and weakness of the respiratory muscles, is associated with a higher level of complaints and more unplanned readmissions to the hospital.
It is important that patients comply with the prescribed nutrition regimen to ensure that nutritional requirements are met. Especially in patients in the community, it is very important to monitor them regularly, to prevent severe weight loss due to a low compliance. Because of lack of time and/or finance, a lot of patients at home do not visit the dietician on a regular basis. This can lead to a decrease in compliance and an increase of weight loss.
This study has been designed, to investigate if tele-monitoring weight results in a decrease of weight loss, a better compliance of sip feed intake and a lower incidence of infections and/or complications in oncology and COPD patients.
- Main changes (audit trail)
- RECORD13-jul-2011 - 15-sep-2011


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