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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 69710
    • Assuta Medical Center
• Norway
  • Tromsoe, Norway, 9038
    • University Hospital North Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of and potential changes in technology acceptance in participants	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).	Up to three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of and potential changes in selected clinical outcomes of participants : BMI, weight, fasting glucose as well as HbA1c levels (sample)	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).	Up to three months
Level of and potential changes in health-related quality of life of participants assessed by EQ5D5L	Use of EQ-5DL a standardised instrument to measure health outcome and health-related quality of life.	Up to three months
Level of and potential changes in uptake and usage of the SENACA intervention by participants	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)	Up to three months
Level of and potential changes in self-efficacy of participants	Measured with the Stanford Self-efficacy for managing chronic disease scale (SES6)	Up to three months
Level of and potential changes in health-related behaviour: nutrition & alcohol consumption, smoking, physical activity	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).	Up to three months
Level of and potential changes in eHealth Literacy in participants	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).	Up to three months

Collaborators and Investigators

• Sponsor: Assuta Medical Center
• Collaborators: Norwegian Centre for Integrated Care and Telemedicine (NST); Open-Evidence c/o Universitat Oberta de Catalunya; Institute for Health and Consumer Protection c/o University of Oslo, Faculty of Medicine; European Medical Network EMN AG
• Investigators: Study Chair: Frank Larsen, MA, Norwegian Centre for Integrated Care and Telemedicine

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Anticipated): August 31, 2017
• Study Completion (Anticipated): August 31, 2017

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: July 11, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: prevention; eHealth; Technology acceptance; Usability; self-management support in chronic illness; Special Orthopaedic Co-Morbidity after hip/knee replacement
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: IFI.2014.0056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No