The main aim of this study is to establish whether patient-centred digital decision systems like the SanaCoach heart failure may be administered to patients as a Web app to improve patient self-management and lifestyle among patients with chronic…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Score on the System Usability Scale (SUS)
• UPDATE-HF sub study: Qualitatively assess the usability of SanaCoach and
acceptability from patients* perspective.
Secondary outcome
Usability:
• % of users who rate SanaCoach heart failure as "easy to use"
• % of users who rate SanaCoach heart failure as "transmits information as
intended"
• % of users who report satisfaction with the content of information received
via SanaCoach heart failure
• % of users motivated/intending to use SanaCoach heart failure
• % of alerts/messages transmitted via the app that are rated "appropriate" by
patient
• % of alerts/messages transmitted via the app that are responded to
appropriately by patient
Feasibility:
• Total number of hours of initial training on the use of SanaCoach heart
failure attended by staff, patients, cardiologist
• Total number of hours of refresher training on the use of SanaCoach heart
failure attended by staff, patients, cardiologists
• Total number of minutes/hours for patient counselling over study duration
• Total number of minutes/hours spent on health record-keeping over study
duration
Acceptability: recruitment and dropout statistics and the sociodemographic and
comorbidity profile of consenting study participants, consenting
nonparticipants, and all potentially eligible patients (Patients who decide not
to participate will be given an option to complete an anonymous
sociodemographic survey):
• Recruitment and retention rates
• Time required to recruit to target
• Number of eligible participants required to recruit the required sample size
• Rate of completion of the intervention (i.e. number of participants who
access and complete all aspects of the intervention including lifestyle coach
support)
• Sociodemographic survey on:
o Age, gender, comorbidities, education, income, family/marital status
o In addition, sociodemographic data (not including smartphone ownership or
education) for study participants will be obtained from their medical records
by care provider.
• Among consenting nonparticipants, the sociodemographic survey will be
administered anonymously (with no possibility of further data linkage) either
using a paper or a Web-based survey.
• Technology readiness index (TRI)
Adherence rates
• number of screens viewed
• number of logins
• cumulative minutes using the app and over what time period (i.e. whether
access is within a discrete period of time or over the entire intervention
period)
• Number of alerts/messages/data transmitted to patient/health care provider by
the app
• Number of alerts/messages/data transmitted between patient and health care
provider via the app
• Number of emergency events where the app was used by patients to expedite
treatment
• Number of events that prompted review by the health care provider
• Number of completed/uncompleted education sessions
• Number of completed/uncompleted monitoring sessions
• Number of goals set and goals met
• Number of advice followed/not followed
• UPDATE-HF sub study: Determine the changes perceived by relatives or informal
caregivers in relation to the patient's disease management through the use of
SanaCoach
Background summary
Heart failure (HF) is one of the most complex chronic disorders with high
prevalence (1) that will continue to rise and is estimated to reach 3% of the
population in Western countries by 2025 (2). It is the most important cause of
hospitalisation in subjects aged 65 years or more, resulting in high costs and
major social impact. Digital medicine offers a potential solution to this
socially urgent problem.
The "SanaCoach heart failure" is an application on the internet that supports
patients and care providers in the development, implementation and monitoring
of patient self-management. The SanaCoach heart failure provides information
about heart failure, treatment, and lifestyle modifications. It can also
monitor the patient's wellbeing, symptoms, vital signs, and gives advice on
whether review with a health care provider is advisable. Furthermore, it
provides a repository for patient's care plan to give insight into the course
and treatment of the disorder.
Study objective
The main aim of this study is to establish whether patient-centred digital
decision systems like the SanaCoach heart failure may be administered to
patients as a Web app to improve patient self-management and lifestyle among
patients with chronic heart failure. The primary study objective is to evaluate
the usability of the digital device named SanaCoach heart failure. The
secondary objectives are to evaluate SanaCoach heart failure's feasibility,
acceptability and clinical efficacy.
The aim of UPDATE-HF substudy is to capture and analyse qualitative data on
patients' experiences dealing with SanaCoach, its user-friendliness
(usability), patients' usage behaviour and self-management skills, as well as
offering an indication on their acceptance towards the digital support system.
Finally, UPDATE-HF evaluates the acceptance of SanaCoach from the relatives
perspective, and its perceived influence on the care of patients with HF. For
this purpose, a quantitative survey is used. Results of this study will provide
valuable information on the improvement and implementation of SanaCoach from
different stakeholder (i.e management, industry, etc.) perspectives. Such has
the potential to make an important impact on the further development process of
the virtual assistant "DoctorMe" in the PASSION-HF project.
Study design
This is a pragmatic, observational, feasibility study. It will be sponsored by
MUMC+ and founded by Interreg NWE. The study will recruit 600 patients across 4
clinical sites in Europe.
In addition, 300 relatives/informal caregivers will be included in the
UPDATE-HF substudy across the four clinical sites.
Study burden and risks
During the study, patients will not be at risk by using the SanaCoach heart
failure, as the investigational digital device is classified as a class I
software in accordance with the Medical Device Coordination Group Document
(MDCG 2019-11). All patients will receive the standard of care of at least 3 to
6 monthly scheduled cardiology visits. No bloodsamples, besides routine care,
or other examinations are preformed on the patients. By participating in this
study patients will fill out 5 questionnaires through the SanaCoach app. All
other functions of SanaCoach heart failure (learning modules and vital check
ups) are preformed at will of the patient. By using these functions, patients
can feel safer because they will feel that they are better monitored by their
doctor.
P.Debyeleaan 25
Maastricht 6229 HX
NL
P.Debyeleaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• Adults (>=18 years) that own a device where SanaCoach heart failure can be
used on
• Diagnosis of chronic heart failure according to ESC 2016 guidelines (HFrEF =
LVEF <40%, HFmrEF = LVEF 40-49%, HFpEF = LVEF >= 50%), based on
echocardiographic or MRI findings within the last year or considered stable
before.
• Ability and willingness to give written informed consent and to comply with
the requirements of the study
UPDATE-HF sub study:
Patient's inclusion criteria
• Be enrolled in the STABILISE-HF study
• Patient may not already use SanaCoach or have used it in the past
• Willingness to have the interview recorded and transcribed
• Sufficient Dutch language skills to answer questions
• Ability and willingness to give written informed consent and to comply with
the requirements of the study
Patient*s relatives/informal caregivers inclusion criteria
• Relative/informal caregiver of a patient diagnosed with HF who has already
been enrolled in the STABILISE-HF study
• Adults (>=18 years)
• Sufficient English language skills to answer questions
• Ability and willingness to give written informed consent and to comply with
the requirements of the study
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Patients without access to a device where SanaCoach heart failure can be used
on
• Uncontrolled or serious disease, or any medical or surgical condition, that
may either interfere with participation in the clinical study, and/or put the
subject at significant risk (according to investigator's judgment) if he/she
participates in the clinical study.
• Patients that have been hospitalised for heart failure within the last 30
days.
• An underlying known disease, or surgical, physical, or medical condition
that, in the opinion of the investigator might interfere with interpretation of
the clinical study results.
• Treatment with other investigational products or devices within 30 days or
five half-lives of the screening visit, whichever is longer.
• Planned use of other investigational products or devices during the course of
the study.
• Any condition that according to the investigator could interfere with the
conduct of the study, such as but not limited to:
• a. Subjects who are unable to communicate or to cooperate with the
investigator.
• b. Unable to understand the protocol requirements, instructions and
study-related restrictions, the nature, scope, and possible consequences of the
study.
• c. Unlikely to comply with the protocol requirements, instructions, and
study-related restrictions (eg, uncooperative attitude, inability to return for
follow-up visits (as parts of standard care), and improbability of completing
the study).
• d. Have any medical or surgical condition, which in the opinion of the
investigator would put the subject at increased risk from participating in the
study
• e. Persons directly involved in the conduct of the study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04699253 |
| CCMO | NL75892.068.20 |