Clinical trial NCT02832739: Exploring Acceptance and Outcomes of an Online-based Self-management Support System in Chronic Illness
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Heart Failure
Diabetes Mellitus
Chronic Obstructive Pulmonary Disease
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
Lead sponsor: Assuta Medical Center
Sponsor class: OTHER
Collaborators: name: Norwegian Centre for Integrated Care and Telemedicine (NST)
name: Open-Evidence c/o Universitat Oberta de Catalunya
name: Institute for Health and Consumer Protection c/o University of Oslo, Faculty of Medicine
name: European Medical Network EMN AG
First posted: 2016-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Level of and potential changes in technology acceptance in participants
timeFrame: Up to three months
Secondary outcomes:
measure: Level of and potential changes in selected clinical outcomes of participants : BMI, weight, fasting glucose as well as HbA1c levels (sample)
timeFrame: Up to three months
measure: Level of and potential changes in health-related quality of life of participants assessed by EQ5D5L
timeFrame: Up to three months
measure: Level of and potential changes in uptake and usage of the SENACA intervention by participants
timeFrame: Up to three months
measure: Level of and potential changes in self-efficacy of participants
timeFrame: Up to three months
measure: Level of and potential changes in health-related behaviour: nutrition & alcohol consumption, smoking, physical activity
timeFrame: Up to three months
measure: Level of and potential changes in eHealth Literacy in participants
timeFrame: Up to three months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
city: Tromsoe
country: Norway
facility: University Hospital North Norway
Study officials:
affiliation: Norwegian Centre for Integrated Care and Telemedicine
name: Frank Larsen, MA
role: STUDY_CHAIR
References: