Coronary Artery DiseaseNCT05713565
A Digital Care Solution for Coronary Artery Disease Patients
A study testing A digital care solution for patients with Coronary Artery Disease in people with Coronary Artery Disease, run by Sidekick Health at 1 site in Iceland.
Trial summary
This is a single center, randomized clinical trial (RCT), recruiting 200 patients with coronary artery disease (CAD) who are currently receiving standard care treatment at the cardiology department of Landspítali University Hospital in Reykjavik, Iceland. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- A digital care solution for patients with Coronary Artery Disease
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteIceland
- Study dates
- 6 Feb 2023to 31 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults diagnosed with coronary artery disease
- Fluent in verbal and written Icelandic
- Capacity to give informed consent
- Capacity to operate a smartphone
Who cannot join
- Not owning a smartphone compatible with the Sidekick Health app or not willing to have it installed on their device
- Not able or willing to comply with study intervention/scheduled measures and visits
- Having another serious medical condition (e.g., cancer, endocarditis, heart failure (EF<40%), history of cardiac arrest)
- Active alcohol or drug abusers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized-controlled Trial Evaluating a Digital Care Solution (Sidekick, SK-121) for Coronary Artery Disease Patients at Landspítali University Hospital
This is a single center, randomized clinical trial (RCT), recruiting 200 patients with coronary artery disease (CAD) who are currently receiving standard care treatment at the cardiology department of Landspítali University Hospital in Reykjavik, Iceland.
The RCT will determine whether an interactive health app that supports lifestyle changes can positively impact disease progression and quality of life of CAD patients. Patients will be randomized to receive either the standard of care (SoC) alone or SoC with the addition of the digital app. The digital app will include remote patient monitoring and a patient support program specific for CAD patients.
The investigators will study the impact of the digitally delivered lifestyle intervention and remote monitoring on disease progression and on the patients' quality of life.
Read the detailed description
Cardiovascular disease (CVD) is the leading cause of death worldwide, with an estimated number of 17.9 million deaths each year. Coronary artery disease (CAD) is the most common form of CVD and is caused by plaque buildup (atherosclerosis) in the walls of the coronary arteries that supply blood to the heart. The plaques consist of deposits of cholesterol, fat, calcium and other substances. Atherosclerosis of the coronary arteries reduces blood flow to the heart and can eventually result in a myocardial infarction.
Lifestyle-related risk factors are known to play an important role in the development of CAD and CVD in general and many of these risk factors are modifiable. The most important modifiable cardiovascular risk factors are an unhealthy diet, physical inactivity, smoking use, and excessive use of alcohol. Improvements in these modifiable risk factors can significantly lower the risk of recurrent events in CVD patients.
Many clinical trials have shown that lifestyle interventions focused on for instance improving diet, physical activity, weight and waist circumference reduce cardiovascular risk scores. Also, recurrence of cardiac events can be reduced by lifestyle interventions as smoking cessation was associated with 43% reduction of recurrent myocardial infarction, and regular exercise and diet modifications reduced the risk of recurrent myocardial infarction by 48%. Exercise intervention reduced mortality by 27% and diet intervention reduced mortality by 26%. While on the other hand reduced physical activity has been shown to increase the risk of cardiac death in CAD patients.
Lifestyle modification has not only been shown to improve quality of life but is also cost-effective. Lifestyle intervention is recommended by clinical guidelines, but a gap exists between recommendations and what is being implemented in clinical practice. Finding simple ways to incorporate lifestyle intervention to standard CAD care could undoubtedly improve patient outcomes and the disease burden.
Because of the widespread ownership of smartphones, digital applications hold promise for providing lifestyle modification support to large numbers of people in a format that is readily accessible at almost any time. Approximately two-thirds of the world's population owns a smartphone, and in 2019 there were 204 billion app downloads. Considering the evidence, the use of digital applications seems supported. However, currently, there is still limited data to draw from on the effectiveness of digitally delivered remote monitoring and patient support programs for CAD patients. As a result, more data is needed.
In this study, Sidekick Health's newly developed digital care solution, including remote patient monitoring (RPM) and a patient support program (PSP) specifically developed for CAD patients, will be tested. Comparing the effect of adding a digital solution to the standard of care (SoC), this study will investigate the impact of a holistic, digitally delivered lifestyle intervention and remote monitoring on disease progression and on the CAD patient's quality of life.
The aim of this study is to test the effectiveness of improving clinical outcomes and quality of life by using the Sidekick Health's CAD digital program in combination with SoC compared to SoC alone.
- Conditions
- Coronary Artery Disease
- Being tested
- A digital care solution for patients with Coronary Artery Disease, Standard of care for patients with Coronary Artery Disease
- Keywords
- coronary artery disease, digital application, lifestyle change, remote monitoring, clinical outcome, quality of life
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A digital care solution for patients with Coronary Artery DiseaseDevice
Also called SK-121
A digital care solution that provides remote patient monitoring and a patient support program specifically developed for CAD patients. The digital care solution empowers self-assessment of CAD symptoms as well as positive lifestyle change by gamification, altruistic rewards, and engaging content with relevant tasks or missions to be completed.
Standard of care for patients with Coronary Artery DiseaseOther
Follow-up and continuous care as usual in outpatient care (i.e., Standard of Care). The participants in the Standard of Care - control group will also receive an information leaflet about relevant lifestyle modifications for CAD.
| Study group | Role | What they receive |
|---|---|---|
| Digital Care Solution group | Experimental | Participants will be instructed to download the SKH mobile app to which the participants will have access for 12 months, and the participants will receive an access code to activate the SKH CAD program. The aim of the program is to empower self-assessment of CAD symptoms as well as positive lifestyle change by gamification, altruistic rewards, and engaging content with relevant tasks or missions to be completed.
Beyond this, all patients in the interventional arm will also receive standard of care as defined below for the control arm. Receives: Device: A digital care solution for patients with Coronary Artery Disease; Other: Standard of care for patients with Coronary Artery Disease |
| Standard of Care - control group | Active comparator | The participants in the Standard of Care - control group will receive an information leaflet about relevant lifestyle modifications for CAD. After baseline measurements and data collection, follow-up and continuous care will be as usual in outpatient care (i.e., Standard of Care). Receives: Other: Standard of care for patients with Coronary Artery Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of recurrent Coronary Artery Disease
Difference in change in total score of the Second Manifestations of ARTerial disease (SMART) risk score between the intervention and control groups.
The SMART Risk Score is based on 13 demographic and clinical parameters, the resulting SMART Risk Scores range from 0 to 100%, with a lower score representing a lower risk.
Measured: 12 months
Secondary outcomes (6)
CAD-specific health status
Difference in change in the total score of the 7-item Seattle Angina Questionnaire - 7 (SAQ-7) between the intervention and control groups.
The SAQ-7 consists of a self-reported list with 7 questions (1a-c and 2-5) where one can choose between six (questions 1a to 3) or five (questions 4 and 5) answers by ticking boxes. The answers of 1a and 1b are on Likert scales where 1 represents "extremely limited" to 6 "limited for other reasons or did not do the activity". The answers of 2 and 3 are on Likert scales where 1 represents "4 or more times per day" to 6 "none over the past 4 weeks". The answers of question 4 are on a Likert scale where 1 represents "it has extremely limited my enjoyment of life" to 5 "it has not limited my enjoyment of life at all". The answers of question 5 are on a Likert scale where 1 represents "not satisfied at all" to 5 "completely satisfied". Scores are on a scale of 7 to 39 with low scores denoting the worst and high scores the best possible status.
Measured: 12 months
Burden of Coronary Artery Disease
Difference in burden of Coronary Artery Disease between intervention and control group as measured by (costs of) number of Coronary Artery Disease-related visits to emergency room, hospital, and the cardiology department.
Measured: 12 months
Medication adherence
Difference in self-assessed medication adherence between intervention and control group as measured by the 8-item Morisky Medication Adherence Scale (MMAS-8).
The MMAS-8 is an 8-item structured, self-reported medication adherence measure. The total score on the MMAS-8 has a range from 0 to 8.0. The 3 categorical Likert Scale is: low adherence is <6, medium adherence is 6 to <8, and high adherence is 8.
Measured: 12 months
Patients self-care and disease knowledge
Difference in self-care and disease knowledge between intervention and control group as measured by the self-assessed Coronary Artery Disease Education Questionnaire - Short Version (CADE-Q SV).
The CADE-Q SV is a 20-item questionnaire where one can choose between three answers by ticking boxes "True", "False", or "I don't know". Each correct answer is given 1 point. The scores on the CADE-Q SV range from 0 to 20, with low scores denoting the worst and high scores the best possible self-care and disease knowledge.
Measured: 12 months
Smoking status
Difference between intervention and control group in self-reported smoking status
Measured: 12 months
Depression, anxiety, and stress levels
Difference in change in the total score of the 21-item Depression, Anxiety and Stress Scale (DASS21) questionnaire between the intervention and control group.
Each question on the DASS21 has a Likert scale of 4 options where 0 represents "did not apply to me" to 3 "applied to me very much". The scores on the subscales range from 0 to 63, and low scores indicate a better mental health status.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start6 Feb 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center prospective randomized open blinded end-point (PROBE)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidekick Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Landspitali University Hospital
- Responsible party
- Sponsor
- Investigators
- David O Arnar, MD, PhD, Principal investigator, National University Hospital of Iceland & University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713565
- Sponsor's protocol ID
- SK-121-CAD
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized Individual Participant Data may be shared with other researchers for relevant research purposes following complementary ethical review and approval from the Ethical Review Board.
Publications
Gudmundsson EF, Dobies B, Laxdal B, Olafsdottir IV, Davidsdottir I, Bragadottir HB, Sigurdardottir S, Isberg AP, Grannell A, Libungan B, Mogensen BA, Halldorsdottir H, Gudmundsdottir MV, Kaernested B, Thorgeirsson T, Oddsson SJ, Arnar DO. Use of a digital health solution after percutaneous coronary intervention: a randomised controlled trial. Front Digit Health. 2026 Jul 21;8:1851777. doi: 10.3389/fdgth.2026.1851777. eCollection 2026.
PubMed 42553118
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized-controlled Trial Evaluating a Digital Care Solution (Sidekick, SK-121) for Coronary Artery Disease Patients at Landspítali University Hospital
- ClinicalTrials.gov ID
- NCT05713565
- Acronym / sponsor ID
- SK-121-CAD
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, digital application, lifestyle change, remote monitoring, clinical outcome, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Sidekick HealthIndustry (pharma, biotech, devices)
- Collaborators
- Landspitali University Hospital
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 6 Feb 2023 (actual)
- 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.
This is a single center, randomized clinical trial (RCT), recruiting 200 patients with coronary artery disease (CAD) who are currently receiving standard care treatment at the cardiology department of Landspítali University Hospital in Reykjavik, Iceland.
The RCT will determine whether an interactive health app that supports lifestyle changes can positively impact disease progression and quality of life of CAD patients. Patients will be randomized to receive either the standard of care (SoC) alone or SoC with the addition of the digital app. The digital app will include remote patient monitoring and a patient support program specific for CAD patients.
The investigators will study the impact of the digitally delivered lifestyle intervention and remote monitoring on disease progression and on the patients' quality of life.
Detailed description
Cardiovascular disease (CVD) is the leading cause of death worldwide, with an estimated number of 17.9 million deaths each year. Coronary artery disease (CAD) is the most common form of CVD and is caused by plaque buildup (atherosclerosis) in the walls of the coronary arteries that supply blood to the heart. The plaques consist of deposits of cholesterol, fat, calcium and other substances. Atherosclerosis of the coronary arteries reduces blood flow to the heart and can eventually result in a myocardial infarction.
Lifestyle-related risk factors are known to play an important role in the development of CAD and CVD in general and many of these risk factors are modifiable. The most important modifiable cardiovascular risk factors are an unhealthy diet, physical inactivity, smoking use, and excessive use of alcohol. Improvements in these modifiable risk factors can significantly lower the risk of recurrent events in CVD patients.
Many clinical trials have shown that lifestyle interventions focused on for instance improving diet, physical activity, weight and waist circumference reduce cardiovascular risk scores. Also, recurrence of cardiac events can be reduced by lifestyle interventions as smoking cessation was associated with 43% reduction of recurrent myocardial infarction, and regular exercise and diet modifications reduced the risk of recurrent myocardial infarction by 48%. Exercise intervention reduced mortality by 27% and diet intervention reduced mortality by 26%. While on the other hand reduced physical activity has been shown to increase the risk of cardiac death in CAD patients.
Lifestyle modification has not only been shown to improve quality of life but is also cost-effective. Lifestyle intervention is recommended by clinical guidelines, but a gap exists between recommendations and what is being implemented in clinical practice. Finding simple ways to incorporate lifestyle intervention to standard CAD care could undoubtedly improve patient outcomes and the disease burden.
Because of the widespread ownership of smartphones, digital applications hold promise for providing lifestyle modification support to large numbers of people in a format that is readily accessible at almost any time. Approximately two-thirds of the world's population owns a smartphone, and in 2019 there were 204 billion app downloads. Considering the evidence, the use of digital applications seems supported. However, currently, there is still limited data to draw from on the effectiveness of digitally delivered remote monitoring and patient support programs for CAD patients. As a result, more data is needed.
In this study, Sidekick Health's newly developed digital care solution, including remote patient monitoring (RPM) and a patient support program (PSP) specifically developed for CAD patients, will be tested. Comparing the effect of adding a digital solution to the standard of care (SoC), this study will investigate the impact of a holistic, digitally delivered lifestyle intervention and remote monitoring on disease progression and on the CAD patient's quality of life.
The aim of this study is to test the effectiveness of improving clinical outcomes and quality of life by using the Sidekick Health's CAD digital program in combination with SoC compared to SoC alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single center prospective randomized open blinded end-point (PROBE)
| Arm | Type | Receives |
|---|---|---|
| Digital Care Solution group | Experimental | Device: A digital care solution for patients with Coronary Artery Disease, Other: Standard of care for patients with Coronary Artery DiseaseParticipants will be instructed to download the SKH mobile app to which the participants will have access for 12 months, and the participants will receive an access code to activate the SKH CAD program. The aim of the program is to empower self-assessment of CAD symptoms as well as positive lifestyle change by gamification, altruistic rewards, and engaging content with relevant tasks or missions to be completed. Beyond this, all patients in the interventional arm will also receive standard of care as defined below for the control arm. |
| Standard of Care - control group | Active comparator | Other: Standard of care for patients with Coronary Artery DiseaseThe participants in the Standard of Care - control group will receive an information leaflet about relevant lifestyle modifications for CAD. After baseline measurements and data collection, follow-up and continuous care will be as usual in outpatient care (i.e., Standard of Care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults diagnosed with coronary artery disease
- Fluent in verbal and written Icelandic
- Capacity to give informed consent
- Capacity to operate a smartphone
Key exclusion criteria (4 listed)
- Not owning a smartphone compatible with the Sidekick Health app or not willing to have it installed on their device
- Not able or willing to comply with study intervention/scheduled measures and visits
- Having another serious medical condition (e.g., cancer, endocarditis, heart failure (EF<40%), history of cardiac arrest)
- Active alcohol or drug abusers
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 |
|---|---|---|
| A digital care solution for patients with Coronary Artery DiseaseAlso: SK-121A digital care solution that provides remote patient monitoring and a patient support program specifically developed for CAD patients. The digital care solution empowers self-assessment of CAD symptoms as well as positive lifestyle change by gamification, altruistic rewards, and engaging content with relevant tasks or missions to be completed. | Device | Digital Care Solution group |
| Standard of care for patients with Coronary Artery DiseaseFollow-up and continuous care as usual in outpatient care (i.e., Standard of Care). The participants in the Standard of Care - control group will also receive an information leaflet about relevant lifestyle modifications for CAD. | Other | Digital Care Solution group, Standard of Care - control group |
Primary outcome
Risk of recurrent Coronary Artery Disease
Time frame: 12 months
Difference in change in total score of the Second Manifestations of ARTerial disease (SMART) risk score between the intervention and control groups. The SMART Risk Score is based on 13 demographic and clinical parameters, the resulting SMART Risk Scores range from 0 to 100%, with a lower score representing a lower risk.
6 secondary outcomes
CAD-specific health status
Time frame: 12 months
Burden of Coronary Artery Disease
Time frame: 12 months
Medication adherence
Time frame: 12 months
Patients self-care and disease knowledge
Time frame: 12 months
Smoking status
Time frame: 12 months
Depression, anxiety, and stress levels
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Derived from this study: PubMed 42553118Gudmundsson EF, Dobies B, Laxdal B, Olafsdottir IV, Davidsdottir I, Bragadottir HB, Sigurdardottir S, Isberg AP, Grannell A, Libungan B, Mogensen BA, Halldorsdottir H, Gudmundsdottir MV, Kaernested B, Thorgeirsson T, Oddsson SJ, Arnar DO. Use of a digital health solution after percutaneous coronary intervention: a randomised controlled trial. Front Digit Health. 2026 Jul 21;8:1851777. doi: 10.3389/fdgth.2026.1851777. eCollection 2026.
- Individual participant dataSharing planned: No. Anonymized Individual Participant Data may be shared with other researchers for relevant research purposes following complementary ethical review and approval from the Ethical Review Board.
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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.
David O Arnar, MD, PhD principal investigator
National University Hospital of Iceland & University of Iceland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A digital care solution for patients with Coronary Artery Disease in people with Coronary Artery Disease, run by Sidekick Health at 1 site in Iceland.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Risk of recurrent Coronary Artery Disease (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05713565, which also lists 1 linked publication.
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 4 Jun 2025.