No registrations found.
ID
Source
Brief title
Health condition
Oncology
COPD
Malnutrition
Weight
Infections
Complications
Sponsors and support
Nutricia Netherlands
Abbott Nutrition
Medizorg
Loodsboot 7
3991 CJ Houten
Tel. +31 30 2804271
Nutricia Netherlands
Albert Einsteinlaan 20
2719 EP Zoetermeer
+31 79 3539000
Abbott Nutrition
Wegalaan 9
2132 JD Hoofddorp
+31 88 8222487
Intervention
Outcome measures
Primary outcome
Weight [kg].
Secondary outcome
1. Sip feed intake [ml/day, % of prescribed];
2. Number of infections [-];
3. Number of complications [-];
4. Unplanned hospitalisations [-].
Background summary
Many 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.
Study objective
The 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.
Study design
Weight:
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.
Intervention
During 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.
Loodsboot 7
Claire Hoogerwerf
Houten 3991 CJ
The Netherlands
+31 (0)30 2804271
clairehoogerwerf@medizorg.nl
Loodsboot 7
Claire Hoogerwerf
Houten 3991 CJ
The Netherlands
+31 (0)30 2804271
clairehoogerwerf@medizorg.nl
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2853 |
| NTR-old | NTR2995 |
| CCMO | NL36151.072.11 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON35829 |