The effect on fluid restriction adherence by monitoring with the MySleeve device, a randomized controlled trail.
- Conditions
- 10038430fluid restriction10014412
- Registration Number
- NL-OMON42773
- Lead Sponsor
- Catharina-ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
- Prevalent hemodialysis patients with a dialysis vintage of at least 3 months.
- Anuric (defined as a urine output of <300ml over 24hours).
- Hemodynamically stable on dialysis, defined as less than 10% hypotensive episodes during the dialysis sessions.
- On a fluid restriction.
- Age above 18 years of age.
- Experience or ability to use a smart-phone.
- On a salt restricted diet educated by the dietician.
- Informed consent.
Exclusion Criteria
- withdrawal of consent
- acute intercurrent illness (infection, malignancy, cardiovascular event, uncontrolled diabetes)
- physically constrained to use the required devices
- mentally unable to use the required devices
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>less IDWG. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Improved sleep quality measured by the activity tracker.<br /><br>Increased physical activity, measured by the activity tracker.<br /><br>Evaluation of user experience, and possible suggestions of improvemend, of the<br /><br>MySleeve device and the BCM sock at the end of the study. </p><br>