Exploring Acceptance and Outcomes of an Online-based Self-management Support System in Chronic Illness (USECARE)
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|ClinicalTrials.gov Identifier: NCT02832739|
Recruitment Status : Active, not recruiting
First Posted : July 14, 2016
Last Update Posted : July 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Heart Failure Diabetes Mellitus Chronic Obstructive Pulmonary Disease Special Orthopaedic Co-Morbidity After Hip/Knee Replacement||Device: SENACA - ICT based self-management support system||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Exploring Acceptance and Outcomes of an ICT-based Self-management Support System for Community-dwelling Older Adults With Chronic Diseases and Informal Caregivers: USECARE Study Protocol|
|Actual Study Start Date :||November 2016|
|Estimated Primary Completion Date :||August 31, 2017|
|Estimated Study Completion Date :||August 31, 2017|
Experimental: SENACA - self-management support system
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 [ Time Frame: Up to three months ]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).
- Level of and potential changes in selected clinical outcomes of participants : BMI, weight, fasting glucose as well as HbA1c levels (sample) [ Time Frame: Up to three months ]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).
- Level of and potential changes in health-related quality of life of participants assessed by EQ5D5L [ Time Frame: Up to three months ]Use of EQ-5DL a standardised instrument to measure health outcome and health-related quality of life.
- Level of and potential changes in uptake and usage of the SENACA intervention by participants [ Time Frame: Up to three months ]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)
- Level of and potential changes in self-efficacy of participants [ Time Frame: Up to three months ]Measured with the Stanford Self-efficacy for managing chronic disease scale (SES6)
- Level of and potential changes in health-related behaviour: nutrition & alcohol consumption, smoking, physical activity [ Time Frame: Up to three months ]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).
- Level of and potential changes in eHealth Literacy in participants [ Time Frame: Up to three months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832739
|Assuta Medical Center|
|Tel Aviv, Israel, 69710|
|University Hospital North Norway|
|Tromsoe, Norway, 9038|
|Study Chair:||Frank Larsen, MA||Norwegian Centre for Integrated Care and Telemedicine|