Exploring Acceptance and Outcomes of an Online-based Self-management Support System in Chronic Illness

Not Applicable

• Conditions: Chronic Heart Failure; Special Orthopaedic Co-Morbidity After Hip/Knee Replacement; Chronic Obstructive Pulmonary Disease; Diabetes Mellitus
• Interventions: Device: SENACA - ICT based self-management support system

• Registration Number: NCT02832739
• Lead Sponsor: Assuta Medical Center

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Study Start: 2016-11
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-06
• Last Update Posted: 2017-07-11
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SENACA - self-management support system	SENACA - ICT based self-management support system	Use of enhanced SENACA - ICT based self-management support system prototype by study participants at home for 75-100 days

Primary Outcome Measures

Name	Time	Method
Level of and potential changes in technology acceptance in participants	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).

Secondary Outcome Measures

Name	Time	Method
Level of and potential changes in health-related quality of life of participants assessed by EQ5D5L	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 self-efficacy of participants	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	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 uptake and usage of the SENACA intervention by participants	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 eHealth Literacy in participants	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).
Level of and potential changes in selected clinical outcomes of participants : BMI, weight, fasting glucose as well as HbA1c levels (sample)	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).

Trial Locations

Locations (2)

Assuta Medical Center; 🇮🇱 Tel Aviv, Israel

University Hospital North Norway; 🇳🇴 Tromsoe, Norway