Cardiac Disease Clinical Trial
Official title:
Longterm Follow-up of Cardiac Patients With an Smartphone-Application -A Randomized Clinical Study
Cardiovascular disease is the leading cause of morbidity and mortality globally. Cardiac
rehabilitation (CR) including exercise training are effective to reduce morbidity, mortality
and risk factors such as physical fitness, cholesterol, triglycerides and blood pressure. The
main goal for CR is to establish exercise training and other lifestyle changes as permanent
changes in the patient's life. Many studies have shown that cardiac patients strive to
maintain a heart-healthy lifestyle, one year after participating in CR. Furthermore, this
leads to risk profile returning to the starting point where they got their Cardiac event.
Changing a lifestyle is known to take time, and we believe that the patients need further
follow-up beyond the time spent in traditional CR.
To our knowledge very few, if any, studies evaluates the use of modern technology in longterm
follow-up focusing on maintaining a new lifestyle after participating in CR. The
investigators would like to evaluate the effect of an dynamic application (app) with regard
to physical fitness, lifestyle and quality of life (QoL), one year after CR. The
investigators hypothesize that patients getting Access to a dynamic Application and tailored
feedback through the application after CR will better be able to take care of physical
Fitness and other lifestyle factors one year after CR, compared to patients getting usal
care.
Introduction:
Smartphones are widespread and in 2015 as much as 82% of the Norwegian population were owners
of a smartphone. Recommendations has been pointed out in a new report from the Norwegian
Board of Technology; health service should facilitate so that patients can follow up their
health from home and simultaneously receive necessary help from the health service. The
Norwegian Directorate of health points in a national action plan for e-health that evidence
based digital tools in combination with an increase of competence will make it possible to
reach health political goals such as quality levels, patient safety and an effective use of
resources.
Across diseases adherence to treatment is one of the most important modifiable factors wich
decreases the treatment effect. As much as 30-50% of patients do not adhere to recommended
treatment. Adherence to treatment is complex and it depends on many factors; the patient, the
patient surroundings (social support, the function of the health service, availability and
resources) and characteristics with the disease and the corresponding treatment. World Health
Organization (WHO) points to adherence to treatment as a global challenge and supports
political decisions and research interventions that will increase adherence. Furthermore,
adherence is considered to be a huge challenge in treatment for lifestyle changes such as
smoking cessation, diet changes, training and physical activity. A meta-analysis (n=42 000)
documented that "mixed mode of delivery interventions", where traditional techniques for
behavior change was combined with digital tools, proved more effective than the use of
traditional techniques for behavior change alone. Another meta-analysis (n=20 000) confirms
this conclusion; therapy, guidance and conversation has an increased effect when it is used
together with dedicated digital tools (6).
Cardiovascular disease is the leading cause of morbidity and mortality globally. Cardiac
rehabilitation (CR) including exercise training are effective to reduce morbidity, mortality
and modifiable risk factors such as physical fitness, cholesterol, triglycerides and blood
pressure. The main goal for CR is to establish exercise training and other lifestyle changes
as permanent changes in the patient's life. Many studies have shown that cardiac patients do
not reach the therapeutic goals regarding secondary prophylaxis one year after participating
in CR. In other words; patients are not able to maintain the new lifestyle after CR and their
risk profile goes back to base. Changing a lifestyle is known to take time, and we believe
that the patients need further follow-up beyond the time spent in traditional CR.
To our knowledge very few studies, if any, evaluates the use of modern technology aiming to
help the patients to maintain a new lifestyle after participating in CR. The investigators
would therefore like to implement a randomized clinical trial (RCT) to evaluate the effect of
the dynamic Application Vett® With regard to physical Fitness (peak oxygen uptake), one year
after CR.
Method:
- Design: The study will be a randomized clinical trial. Patients will be recruited from
CR at Norwegian Institute of Sports Medicine (NIMI) and from Feiring. NIMI has an
outpatient CR programme lasting for twelve weeks. Feiring has Institutional CR With two
different durations at their programmes, whereas one of the programmes lasting four
weeks an the other programme lasting for one week. The investigators will conduct a
stratified randomization to ensure Equal number of patients from the different CR
programmes into the intervention-group and the Control Group. Patients will be recruited
when they finish CR.
- Intervention-group: In addition to usal care, patients in the intervention-group will
get access to the application Vett®, as well as approximately one hour of training on
how to use it and register personal goals together with study-coordinator. They will for
a period of approximately twelve months have access to Vett® as well as personal
follow-up through the app by a specialized physiotherapist. Vett® is an app developed by
professor Kari Jorunn Kværner, doctor and specialist in cognitive training, guidance and
counseling. Patients will be encouraged to set a minimum of two goals with associated
tasks for the follow-up periode. Tasks will be the basis for reminders which the
Application gives the patient. The patient decide when and how often reminders should
come. The goals and tasks will be set according to the needs of each patient
(individualized). The follow-up is individualized and dynamic and targets the patient
under evaluation directly. Vett® makes it possible to create and set individual goals
(e.g. exercise or eating fish) with tasks and reminders, weekly evaluation of the
individual goals and ask questions to the supervisor. The application also gives the
opportunity to receive tailored and motivational feedback from the supervisor. The
supervisor has access to an administrator interface where it is possible to monitor what
the patients are registering in relation to their personal goals and tasks, as well as
sending tailored and motivational feedback. In this study, the patients will receive
tailored feedback based on their achievements on personal goals and tasks through
e-mail. They will receive feedback every week for the first Three months, then they will
receive feedback as often as they want based on the conversation when included to the
study. They will also receive 1-3 motivational feedbacks/notifications every week. Any
questions to the supervisor will be answered by two working days. In the event of
receiving health related questions (e.g changing of medication or chest pain) the
patients will be advised to contact their general practitioner (GP). One year after CR
patients will be called for a check-up, including questionnaires and a cardiorespiratory
Fitness test.
- Control-Group: Patients in the control-group will receive what is current practice. In
addition they will be called for a check-up, one year after entering CR, including
questionnaires and a cardiorespiratory Fitness test. To day, usual care consist of
advice regarding how to maintain their New lifestyle (exercise training, physical
Activity and heart-healthy diet) and further follow-up by their GP.
- Power calculation: With a significant Level of 5%, Power of 0,80 and a effect size at
0,58 (Clinical important change as 3,5 ml/kg/min i VO2peak and a Standard deviation of 6
ml/kg/min), 48 patients is needed in each Group. With an estimated drop-out of 20%, 115
patients will be recruited to this study.
- Statistical analyzes: Both Parametric and non-Parametric analyzes will be used depending
on the variables. Both intention-to-treat and per-protocol analyzes will be conducted in
the effect-analyzes. T-test and variance analyzes will be used to investigate
differences between Groups.
This study will provide New knowledge about the use of modern Technology with an
Smartphone-Application in the follow-up of Cardiac patients. If the Application proves to be
effective, this study will give clinicians a digital and evidence based tool for longterm
follow-up of patients where changing lifestyle is the primary treatment.
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