An interventional study of SENACA - ICT based self-management support system in Chronic Heart Failure, Diabetes Mellitus and Chronic Obstructive Pulmonary Disease, sponsored by Assuta Medical Center. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-11.
Sponsored by Assuta Medical Center · Not applicable, Interventional, and Health services research
The aim of the USECARE project is to improve and test SENACA, an ICT-based self-management support system for chronically ill patients and informal caregivers. 60 end-users will be instructed to use SENACA for approx. 3 months (in Israel and Norway). Amongst others, clinical and behavioural outcomes will be recorded. Additionally, SENACA's usability will be evaluated to determine its potential future scalability.
In Switzerland, SENior health ACAdemy (SENACA, www.senaca.ch) has been developed by the European Medical Network EMN.
SENACA is a structured self-management support system with several interacting components, combining tele-monitoring devices and a solution for personalised health plans. This online support system's usability, the behaviour change techniques it builds on, modes of delivery and its effects on health-related behaviour, clinical and Quality-of-Life outcomes will be established in a larger group of end-users.
Testing the usability of SENACA and practical effectiveness of this intervention is the goal of this multi-national project USECARE (www.usecare.eu).
SENACA will be implemented in two countries (Israel and Norway ) via field test with community-dwelling older adults living with chronic conditions (i.e. diabetes, COPD, chronic heart failure) and their informal caregivers.
Key element of USECARE is a field-test including a study based upon pre-experimental design with three time point measurements and a pre-usability round. Multiple methods will be used to evaluate the usability and to observe clinical and process parameters before, during and after the implementation of the enhanced SENACA prototype.
All of the results combined will provide an insight into the end-user experience, usage pattern, usability perception and potential added value of the enhanced SENACA prototype for chronic disease management in the participating countries.
11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 30 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Assuta Medical Center is the lead sponsor of 43 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion community-dwelling older adults (primary end-users):
receive medical care for one or more of the following chronic diseases in hospital settings and outpatient clinics:
Exclusion community-dwelling older adults (primary end-users):
Inclusion informal caregivers (secondary end-users):
Both inclusion criteria primary and secondary end-users:
Both exclusion criteria primary and secondary end-users:
Use of enhanced SENACA - ICT based self-management support system prototype by study participants at home for 75-100 days
Device: SENACA - ICT based self-management support system
SENACA - ICT based self-management support system is a structured self-management support system with several interacting components, combining tele-monitoring devices and a solution for personalised health plans. ==\> www.senaca.ch
Level of and potential changes in technology acceptance in participants
Technology acceptance (usability) of system is measured by assessing participants' intention to use, perceived ease of use, perceived usefulness, technology experience, preference in using technology, errors, and user satisfaction. Instruments used are: Technology Acceptance Model (TAM), Post-Study System Usability Questionnaire (PSSUQ), all self-reported questionnaires. In addition, system errors will be reported (number and type of problems).
Time frame: Up to three months
Level of and potential changes in selected clinical outcomes of participants : BMI, weight, fasting glucose as well as HbA1c levels (sample)
Changes in selected clinical outcomes will be assessed with automated measurements via the intervention devices concerning body fat (fat proportion of body in %), body weight (in kg), blood pressure (systolic/diastolic in mmHg), pulse (per minute), SpO2 (in %) and fasting glucose (mmol). In Norway sample laboratory test will be conducted to determine levels of cholesterols (HDL, LDL in mmol), triglyceride (in mmol), HbA1c (mmol) and BNP (pg/ml).
Time frame: Up to three months
Level of and potential changes in health-related quality of life of participants assessed by EQ5D5L
Use of EQ-5DL a standardised instrument to measure health outcome and health-related quality of life.
Time frame: Up to three months
Level of and potential changes in uptake and usage of the SENACA intervention by participants
Automated recording of relative frequency of usage of SENACA's modules (usage of single components that are not mandatory), adherence to SENACA (Number of days within program from initiation to discontinuation (time to event), errors of system during intervention (number and type of technical problems occurring)
Time frame: Up to three months
Level of and potential changes in self-efficacy of participants
Measured with the Stanford Self-efficacy for managing chronic disease scale (SES6)
Time frame: Up to three months
Level of and potential changes in health-related behaviour: nutrition & alcohol consumption, smoking, physical activity
Self-reported questionnaires on weekly unit consumption (nutrition/alcohol), exercise (in Norway) and walking (minutes or hours/week), smoking behaviour (tobacco products, consumption per day), alcohol (units/week).Physical activity will be recorded automatically via pedometer (device).
Time frame: Up to three months
Level of and potential changes in eHealth Literacy in participants
eHealth Literacy is defined as the ability to read, use computers, search for information, understand health information, and put it into context.The eHealth Literacy Scale (eHEALS) as an 8-item measure will be used (self-reported questionnaire).
Time frame: Up to three months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2016 (actual). Primary completion is estimated for Aug 2017, 9 months after the start.
Of 2,196 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 9 months is below that.
Counting every sponsor, half of 2,388 studies reached it within 20 months; a quarter within 9 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Assuta Medical Center