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

Primary Purpose

Chronic Heart Failure, Diabetes Mellitus, Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SENACA - ICT based self-management support system
Sponsored by
Assuta Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Heart Failure focused on measuring Technology acceptance, Usability, eHealth, self-management support in chronic illness, prevention, Special Orthopaedic Co-Morbidity after hip/knee replacement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Assuta Medical Center
  • University Hospital North Norway

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SENACA - self-management support system

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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)
Level of and potential changes in self-efficacy of participants
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
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 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).

Full Information

First Posted
June 8, 2016
Last Updated
July 6, 2017
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
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1. Study Identification

Unique Protocol Identification Number
NCT02832739
Brief Title
Exploring Acceptance and Outcomes of an Online-based Self-management Support System in Chronic Illness
Acronym
USECARE
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

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (Actual)
Primary Completion Date
August 31, 2017 (Anticipated)
Study Completion Date
August 31, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SENACA - self-management support system
Arm Type
Experimental
Arm Description
Use of enhanced SENACA - ICT based self-management support system prototype by study participants at home for 75-100 days
Intervention Type
Device
Intervention Name(s)
SENACA - ICT based self-management support system
Intervention Description
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
Primary Outcome Measure Information:
Title
Level of and potential changes in technology acceptance in participants
Description
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).
Time Frame
Up to three months
Secondary Outcome Measure Information:
Title
Level of and potential changes in selected clinical outcomes of participants : BMI, weight, fasting glucose as well as HbA1c levels (sample)
Description
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).
Time Frame
Up to three months
Title
Level of and potential changes in health-related quality of life of participants assessed by EQ5D5L
Description
Use of EQ-5DL a standardised instrument to measure health outcome and health-related quality of life.
Time Frame
Up to three months
Title
Level of and potential changes in uptake and usage of the SENACA intervention by participants
Description
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)
Time Frame
Up to three months
Title
Level of and potential changes in self-efficacy of participants
Description
Measured with the Stanford Self-efficacy for managing chronic disease scale (SES6)
Time Frame
Up to three months
Title
Level of and potential changes in health-related behaviour: nutrition & alcohol consumption, smoking, physical activity
Description
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).
Time Frame
Up to three months
Title
Level of and potential changes in eHealth Literacy in participants
Description
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).
Time Frame
Up to three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: Chronic Heart Failure (CHF, New York Heart Association NYHA IIIIIa); Diabetes Mellitus (DM, 6< HbA1c<9), Chronic Obstructive Pulmonary Disease (COPD, GOLD I-II) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Larsen, MA
Organizational Affiliation
Norwegian Centre for Integrated Care and Telemedicine
Official's Role
Study Chair
Facility Information:
Facility Name
Assuta Medical Center
City
Tel Aviv
ZIP/Postal Code
69710
Country
Israel
Facility Name
University Hospital North Norway
City
Tromsoe
ZIP/Postal Code
9038
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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

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