|- candidate number||24387|
|- NTR Number||NTR5868|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-mei-2016|
|- Secondary IDs||MEC 16-N-15 |
|- Public Title||Smart registration of fluid intake with the 'Smart Mug'|
|- Scientific Title||Smart registration of fluid intake with the 'Smart Mug'; a validation and feasibility study|
|- hypothesis||The hypothesis is an average - good validity with a minimum value of r=0.5.|
The second hypothesis is a positive subjective feasibility/usability of the 'Smart Mug'.
|- Healt Condition(s) or Problem(s) studied||Frailty, Desiccation, Elderly living in resdidential homes for the elderly|
|- Inclusion criteria||Capable to drink from the 'Smart Mug' without assistance;|
Motivated to participate in the study.
|- Exclusion criteria||Elderly with a cognitive impairment (based on the treating general practitioners' opinion).|
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||9-mei-2016|
|- planned closingdate||31-dec-2016|
|- Target number of participants||20|
|- Interventions||Phase 1: elderly will drink from the 'Smart Mug' 5 times a day for one day, based on regular drinking moments in the nursing home residence.|
Phase 2: elderly will drink from the 'Smart Mug' voluntary during a period of 24 hours.
|- Primary outcome||Validity study: The amount of fluid intake (measured by means of the amount of fluid left over in the mug (ml) and the amount of fluid drank by an elderly by observation (approximated ml)), compared to the fluid intake and left over measurement by the 'Smart Mug' itself.|
Feasibility/usability study, topics: overall impression, ease of use, acceptance and usability in daily life (by interviews and PSSUQ questionnaire).
|- Secondary outcome||Age, gender, index disease (if applicable), comorbidity (if applicable) and special occasion such as tipping over the 'Smart Mug' (by observation).
|- Timepoints||two consecutive days, with the observations, interviews and questionnaire on the same days|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Magda van Gastel|
|- CONTACT for SCIENTIFIC QUERIES|| Magda van Gastel|
|- Sponsor/Initiator ||Meetpunt (EIZT/Zuyd Hogeschool)|
(Source(s) of Monetary or Material Support)
|Limburg Economic Development (LED): MKB meets Healthcare nr Z12887|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||23-mei-2016 - 2-jul-2016|