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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24869
Enrollment
168
Registered
2011-07-13
Start date
2011-07-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oncology COPD Malnutrition Weight Infections Complications

Interventions

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.

Sponsors

Medizorg BV 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
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Life expectancy < 6 months; 2. Subject who is frequently seen by a dietician (&#8805; 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 outcomes

Primary

MeasureTime frame
Weight [kg].

Secondary

MeasureTime frame
1. Sip feed intake [ml/day, % of prescribed]; 2. Number of infections [-]; 3. Number of complications [-]; 4. Unplanned hospitalisations [-].

Contacts

Public ContactClaire Hoogerwerf

Medizorg BV Loodsboot 7

clairehoogerwerf@medizorg.nl+31 (0)30 2804271

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)