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

Completed

• Conditions: Gewichtsverlies; Weight loss

• Registration Number: NL-OMON35829
• Lead Sponsor: Medizorg BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 168

Inclusion Criteria

- Male or female adult * 18 years of age
- Oncology or COPD patient
- Risk of malnutrition (assessed by a validated screening tool)
- Subject is prescribed sip feed at home for at least 3 months
- Written informed consent from subject

Exclusion Criteria

- Life expectancy < 6 months
- Subject who is frequently seen by a dietician (> 2 times/month)
- Investigator*s uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- Participation in any other study involving investigational or marketed products concomitantly or within two weeks prior to entry the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameter in this study (change from baseline):<br /><br>- Weight [kg] </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters in this study are:<br /><br>- Sip feed intake [ml/day, % of prescribed]<br /><br>- Number of complications<br /><br>- Number of infections<br /><br>- Number of unplanned hospitalization </p><br>