The objective of the study is to evaluate the benefit of the eCoach in the general practitioner*s office within cardiovascular risk management. Specifically, the eCoach evaluates the effect on individual risk factors and the risk on developing…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes of the effect evaluation are changes in individual risk
factors and the general risk of atherosclerotic coronary disease after six
months. Changes in risk factors are measured by LDL-cholesterol, (systolic)
blood pressure, smoking status, physical exercise measured using the CHAMPS
questionnaire and the dietary change measured using the **eatscore**
questionnaire. Changes in the risk of atherosclerotic coronary disease is
measured using the risk score via the eCoach
Secondary outcome
The secondary outcomes of the effect evaluation are quality of life (EQ-5D
questionnaire), satisfaction of the care delivered and the user-experience of
the eCoach (questionnaire, focus groups).
The user-experience of the eCoach will be evaluated in individual interviews
and focus groups with the practitioner*s assistant (N = 4) and participants (N
= 20).
Background summary
Cardiovascular disease is an important health issue, prominently in the region
of **south-Limburg** the Netherlands. Unhealthy lifestyle plays a prominent
role in the development of cardiovascular disease. Cardiovascular risk
management (CVRM) faces a variety of challenges.
Current risk models for CVRM only focus on demographic features (like age and
gender) and conventional risk factors (like hypertension, hypercholesterolemia
and smoking). A risk profile that weighs unconventional risk factors (like
residence, education, income and physical activity) could lead to a more
accurate prediction model of personal risk. Moreover, it could provide insight
on the effects of potential lifestyle changes.
The output of the current risk models are mainly focusing on the health care
provider, not the patient. Risk communication should be adjusted to the
patients* needs. Patients should understand their risk for developing
cardiovascular disease, understand the urgency for healthy lifestyle changes
and motivate to start lifestyle changes. However, risk awareness is just part
of CVRM. The first step towards lifestyle adjustment proves the hardest for
most, but is an important one. People might find by the amount of lifestyle
interventions available overwhelming, which makes finding the right
intervention challenging for both the health care professional and the patient.
Proper tools to that help find the right intervention, tailored to the patient,
could be useful.
CARRIER offers a personalized eCoach for transmural networks for CVRM (both in
primary and secondary prevention). The first phase of the CARRIER project is
the development of the eCoach, iterated and co-created with the users, and
specifically tailored to atherosclerotic coronary disease. The eCoach will be
implemented in the consult with the patients (prediction model, risk
communication, guidance in choosing a lifestyle intervention) and offers
supports afterwards (information modules, periodic monitoring and follow-up).
Previous, relatively small studies have provided knowledge in the different
usability aspects. The eCoach is optimized based on the technical and
content-related points of improvement found by these previous studies.
Study objective
The objective of the study is to evaluate the benefit of the eCoach in the
general practitioner*s office within cardiovascular risk management.
Specifically, the eCoach evaluates the effect on individual risk factors and
the risk on developing atherosclerotic coronary disease. Secondary objectives
of the effect evaluation include quality of life, satisfaction of the care
delivered and the user-experience of the eCoach.
Study design
The effect evaluation will take place in the eastern region of **South-
Limburg**, in cooperation with two to four general practitioner*s offices. The
duration of the study for each individual patient comprises of six months. The
design of the study is a one group pretest posttest design; an interventional
study in which all participants are provided with the eCoach.
First contact with potential participants is at the CVRM outpatient clinic. The
practitioner*s assistant calculates the risk for atherosclerotic coronary
disease, explains the outcomes of the risk calculation with the patient and the
impact of lifestyle changes on their risk for atherosclerotic coronary disease.
Next, the practitioner*s assistant and the patient use the **choice guide (NL:
keuzehulp)** of the eCoach to select a tailored (pre-existing) intervention and
fill out the periodic monitoring in the eCoach. The practitioner*s assistant
and patient schedule a new appointment in six months for evaluation, new risk
calculation and follow-up.
Measuring moments are scheduled at baseline (first contact), three months and
six months. Content of the measuring moments include digital questionnaires,
(group) interviews and log files.
Intervention
The eCoach comprises of a web-application, partly accessible for the healthcare
professional and partly for the patient. After inclusion, by the practitioner*s
assistant or the scientist registers the patient for the eCoach. Two weeks
prior to the CVRM outpatient visit, the patient is informed about the study, is
requested to log into the eCoach and is requested to fill out a screening
questionnaire (part 1). The screening questionnaire consists of questions about
age, gender, occupancy, smoking habit, physical activity and diet. The patient
is also requested to come in for CVRM blood sampling (LDL-cholesterol).
During the CVRM outpatient visit, the practitioner*s assistant fill out part 2
of the screening questionnaire. Part 2 of the questionnaire involved blood
pressure, cholesterol status and use of medication. Based on the answers of the
screening questionnaire, an individual risk score on atherosclerotic coronary
disease is calculated. Additionally, the individual risk is calculated after
applying hypothetical lifestyle changes, which including quitting smoking,
increasing daily physical activity, healthy dieting and changes in blood
pressure or cholesterol levels. The dashboard displays these risks, in which
hypothetical changes in risk factors provide insight on the actual change in
risk for atherosclerotic coronary disease. The patient and the practitioner*s
assistant decide on a risk factor they want to tackle, after which a tailored
intervention in chosen.
Depending on the chosen risk factor from the **choice card (NL: keuzekaart)**
could help decide on an intervention. The **choice cards** contain information
about the variety of lifestyle interventions (e.g. online versus offline,
individual versus group, short versus long, reimbursed or not). Moreover, the
first step to start the intervention is mentioned (e.g. downloading an app,
applying on a website, referral by healthcare professional or recipe for a
medication). The practitioner*s assistant could provide alternative
interventions not offered on the **choice card**, if desirable.
After the CVRM visit, the patients starts the intervention. The patient will
receive weekly monitoring in the first month via the eCoach (with a short
questionnaire), after which they receive monthly monitoring until the end of
study at six months. The healthcare professional can monitor the questionnaires
remotely. The message function of the eCoach serves the purpose of premature
contact if desirable.
After six months, the participant is invited for the second CVRM visit. Before
the visit, the patient is requested to fill out the screening questionnaire
again (part 1) and the practitioner*s assistant will fill out part 2 of the
questionnaire. The personal risk is re-calculated, re-evaluated and follow-up
after the study is discussed.
Study burden and risks
The risk for participation is minimal. The current health status of the
patients in the starting point, from which the study designs the intervention.
During the CVRM consultation, individual risk (for atherosclerotic coronary
disease) is discussed with the patient and the influence of tackling specific
risk factors on that risk. The patient and the practitioner*s assistant decide
on the risk factor they want to tackle, after which a tailored intervention is
chosen (with the highest chances of succesful behavioural change).
Presenting the patient with their risk for atherosclerotic coronary disease
could frighten patients. The practitioner*s assitent will pay attention to this
and acts accordingly. Moreover, the eCoach provides the opportunity to message
the practitioner*s assitent to ask questions during the monitoring period.
The advantage of participation is to increase awareness of the participant*s
personal risk on developing atherosclerotic coronary disease, tools to tackle
this risk and interventions that help tackle this risk. Participating in the
intervention should create awareness, motivation and knowledge on how to tackle
atherosclerotic coronary disease.
Duboisdomein 30
Maastricht 6229 GT
NL
Duboisdomein 30
Maastricht 6229 GT
NL
Listed location countries
Age
Inclusion criteria
Aged 40-70 years
Visiting CVRM consultation at general practice
Exclusion criteria
Diagnose Artheroscleroc Cardovascular Disease (ASCVD)
Diagnose Diabetes Meltius (DM)
Insufficent mastery of Dutch language
Insufficient digital skills
No access to hardware (smartphone, computer, tablet-pc) with internet connection
Known cognitive impairment
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 |
---|---|
CCMO | NL84584.096.23 |