Chronic Heart FailureUSECARENCT02832739
Exploring Acceptance and Outcomes of an Online-based Self-management Support System in Chronic Illness
A study testing SENACA - ICT based self-management support system in people with Chronic Heart Failure and Diabetes Mellitus, run by Assuta Medical Center at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Heart Failure, Diabetes Mellitus, Chronic Obstructive Pulmonary Disease
- What is being tested?
- SENACA - ICT based self-management support system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2016to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- does not have a stable address of residence
- no internet/computer access
- inability to handle ICT-devices due to cognitive or functional disabilities
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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.
Read the 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
- Being tested
- SENACA - ICT based self-management support system
- Keywords
- Technology acceptance, Usability, eHealth, self-management support in chronic illness, prevention, Special Orthopaedic Co-Morbidity after hip/knee replacement
- Medical subject headings
- Diabetes Mellitus, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENACA - ICT based self-management support systemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| SENACA - self-management support system | Experimental | Use of enhanced SENACA - ICT based self-management support system prototype by study participants at home for 75-100 days Receives: Device: SENACA - ICT based self-management support system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to three months
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: Up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startNov 2016
- Primary completion31 Aug 2017 (estimated)
- Study completion31 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Centre for Integrated Care and Telemedicine, 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
- Responsible party
- Principal investigator, Jacob Gindin, Assuta Medical Center
- Investigators
- Frank Larsen, MA, Study chair, Norwegian Centre for Integrated Care and Telemedicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832739
- Sponsor's protocol ID
- IFI.2014.0056
- Acronym
- USECARE
- Status last verified
- Jul 2017
- First submitted
- 8 Jun 2016
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02832739
- Acronym / sponsor ID
- USECARE / IFI.2014.0056
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Collaborators
- Norwegian Centre for Integrated Care and Telemedicine, 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
- Study start
- Nov 2016 (actual)
- Primary completion
- 31 Aug 2017 (estimated)
- Study completion
- 31 Aug 2017 (estimated)
- First posted
- 14 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SENACA - self-management support system | Experimental | Device: SENACA - ICT based self-management support systemUse of enhanced SENACA - ICT based self-management support system prototype by study participants at home for 75-100 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- does not have a stable address of residence
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENACA - ICT based self-management support systemSENACA - 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 | Device | SENACA - self-management support system |
Primary outcome
Level of and potential changes in technology acceptance in participants
Time frame: Up to three months
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).
6 secondary outcomes
Level of and potential changes in selected clinical outcomes of participants : BMI, weight, fasting glucose as well as HbA1c levels (sample)
Time frame: Up to three months
Level of and potential changes in health-related quality of life of participants assessed by EQ5D5L
Time frame: Up to three months
Level of and potential changes in uptake and usage of the SENACA intervention by participants
Time frame: Up to three months
Level of and potential changes in self-efficacy of participants
Time frame: Up to three months
Level of and potential changes in health-related behaviour: nutrition & alcohol consumption, smoking, physical activity
Time frame: Up to three months
Level of and potential changes in eHealth Literacy in participants
Time frame: Up to three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Larsen, MA study chair
Norwegian Centre for Integrated Care and Telemedicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENACA - ICT based self-management support system in people with Chronic Heart Failure and Diabetes Mellitus, run by Assuta Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of and potential changes in technology acceptance in participants (time frame: Up to three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.