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

NCT ID: NCT02832739

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-08-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

SENACA - ICT based self-management support system

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• written informed consent
• adequate functional, sensory and cognitive abilities to use the SENACA system

Exclusion Criteria

• does not have a stable address of residence
• no internet/computer access
• inability to handle ICT-devices due to cognitive or functional disabilities

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norwegian Centre for Integrated Care and Telemedicine (NST)

UNKNOWN

Sponsor Role: collaborator

Open-Evidence c/o Universitat Oberta de Catalunya

UNKNOWN

Sponsor Role: collaborator

Institute for Health and Consumer Protection c/o University of Oslo, Faculty of Medicine

UNKNOWN

Sponsor Role: collaborator

European Medical Network EMN AG

UNKNOWN

Sponsor Role: collaborator

Assuta Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jacob Gindin

Director Geriatric Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Larsen, MA

Role: STUDY_CHAIR

Norwegian Centre for Integrated Care and Telemedicine

Locations

Assuta Medical Center

Tel Aviv, , Israel

University Hospital North Norway

Tromsø, , Norway

Countries

Israel; Norway

Other Identifiers

IFI.2014.0056

Identifier Type: -

Identifier Source: org_study_id