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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02832739
Acronym
USECARE
Enrollment
30
Registered
2016-07-14
Start date
2016-11-30
Completion date
2017-08-31
Last updated
2017-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure, Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, Special Orthopaedic Co-Morbidity After Hip/Knee Replacement

Keywords

Technology acceptance, Usability, eHealth, self-management support in chronic illness, prevention, Special Orthopaedic Co-Morbidity after hip/knee replacement

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.

Interventions

DEVICESENACA - 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

Sponsors

Norwegian Centre for Integrated Care and Telemedicine (NST)
CollaboratorUNKNOWN
Open-Evidence c/o Universitat Oberta de Catalunya
CollaboratorUNKNOWN
Institute for Health and Consumer Protection c/o University of Oslo, Faculty of Medicine
CollaboratorUNKNOWN
European Medical Network EMN AG
CollaboratorUNKNOWN
Assuta Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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: 1. Chronic Heart Failure (CHF, New York Heart Association NYHA IIIIIa); 2. Diabetes Mellitus (DM, 6\< HbA1c\<9), 3. Chronic Obstructive Pulmonary Disease (COPD, GOLD I-II) 4. Special Orthopaedic Co-Morbidity (SOCM, after elective hip or knee replacement, health status temporarily destabilized respectively challenged, increased monitoring and formal/informal care). * having support of an informal caregiver that is aged 18 years or older * aged 50 years and older (primary end-users) Exclusion community-dwelling older adults (primary end-users): * known illiteracy (reading and writing difficulties) * lack of local language proficiency * current major mental illness of moderate to severe level * major acute illness or surgery in past 3 months (except elective hip / knee surgery for patients with SOCM) * participation in another intervention study Inclusion informal caregivers (secondary end-users): * aged 18 years or older * named by primary end-user as designated informal caregiver providing physical, emotional and/or social support for him or her Both inclusion criteria primary and secondary end-users: * written informed consent * adequate functional, sensory and cognitive abilities to use the SENACA system Both

Exclusion criteria

primary and secondary end-users: * does not have a stable address of residence * no internet/computer access * inability to handle ICT-devices due to cognitive or functional disabilities

Design outcomes

Primary

MeasureTime frameDescription
Level of and potential changes in technology acceptance in participantsUp to three monthsTechnology 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

MeasureTime frameDescription
Level of and potential changes in health-related quality of life of participants assessed by EQ5D5LUp to three monthsUse 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 participantsUp to three monthsAutomated 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 selected clinical outcomes of participants : BMI, weight, fasting glucose as well as HbA1c levels (sample)Up to three monthsChanges 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 behaviour: nutrition & alcohol consumption, smoking, physical activityUp to three monthsSelf-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 participantsUp to three monthseHealth 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 self-efficacy of participantsUp to three monthsMeasured with the Stanford Self-efficacy for managing chronic disease scale (SES6)

Countries

Israel, Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026