The objective of this study is to achieve better adherence to fluid restriction by providing insight to patient*s drinking behavior, by using the MySleeve device (MS).
ID
Source
Brief title
Condition
- Electrolyte and fluid balance conditions
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
less IDWG.
Secondary outcome
Improved sleep quality measured by the activity tracker.
Increased physical activity, measured by the activity tracker.
Evaluation of user experience, and possible suggestions of improvemend, of the
MySleeve device and the BCM sock at the end of the study.
Background summary
In anuric hemodialysis (HD) patients a fluid restriction of 1L to 1.5L per 24
hours is applied to minimize fluid accumulation between two consecutive
dialysis sessions. The amount of fluid accumulated can be estimated by the
patients weight before dialysis, minus the weight at the end of the previous
dialysis session also called inter-dialysis weight gain (IDWG). High IDWG can
lead to symptoms of fluid overload as dyspnea as the result of pulmonary edema,
decreased appetite or pain and discomfort due to peripheral edema. It is also
associated with lower overall survival in this patients* group. Due to multiple
factors that influence the adherence to fluid restriction, for example thirst,
personal habits and social factors, only 30-60% of the HD patients are able to
adhere to their fluid restriction.
Hypothesis:
Better adherence to fluid restriction by profiding insight in drinking
behaviour by using the MySleeve.
Study objective
The objective of this study is to achieve better adherence to fluid restriction
by providing insight to patient*s drinking behavior, by using the MySleeve
device (MS).
Study design
Randomized controlled trial.
All patients will receive an activity tracker to wear throughout the total
study period. Also two questionnaires (one at the beginning and one at the end
of the study period) need to be filled out. Also patients participating in this
study will receive weekly in-clinic (at the dialysis ward) BCM measurements
instead of 2-4 four times per year. Patients randomized for the intervention
group will also receive a BCM sock and are asked to perform a daily in-home BCM
measurement of approximately two minutes, throughout the total study period of
four months. They will also receive the MySleeve vessel with accompanying
ceramic cup, to use for all drinks during the intervention period of one month.
The activity tracker is used to observe their activity levels during the study
period. Both the BCM sock and activity tracker will only measure data and not
present any results to the participants directly.
Study burden and risks
Minimal, only non-invasive measurements are used.
Michelangelolaan 2
Eindhoven 5623EJ
NL
Michelangelolaan 2
Eindhoven 5623EJ
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53778.100.15 |