search
Back to results

A Digital Care Solution for Coronary Artery Disease Patients

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
A digital care solution for patients with Coronary Artery Disease
Standard of care for patients with Coronary Artery Disease
Sponsored by
Sidekick Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, digital application, lifestyle change, remote monitoring, clinical outcome, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults diagnosed with coronary artery disease Fluent in verbal and written Icelandic Capacity to give informed consent Capacity to operate a smartphone Exclusion Criteria: 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

Sites / Locations

  • Landspítali University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital Care Solution group

Standard of Care - control group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Smoking status
Difference between intervention and control group in self-reported smoking status
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.

Full Information

First Posted
January 25, 2023
Last Updated
February 22, 2023
Sponsor
Sidekick Health
Collaborators
Landspitali University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05713565
Brief Title
A Digital Care Solution for Coronary Artery Disease Patients
Official Title
A Randomized-controlled Trial Evaluating a Digital Care Solution (Sidekick, SK-121) for Coronary Artery Disease Patients at Landspítali University Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidekick Health
Collaborators
Landspitali University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, digital application, lifestyle change, remote monitoring, clinical outcome, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single center prospective randomized open blinded end-point (PROBE)
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be blinded for group assignment at the 6-, and 12-month follow-up visit.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digital Care Solution group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care - control group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
A digital care solution for patients with Coronary Artery Disease
Other Intervention Name(s)
SK-121
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of care for patients with Coronary Artery Disease
Intervention Description
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.
Primary Outcome Measure Information:
Title
Risk of recurrent Coronary Artery Disease
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
CAD-specific health status
Description
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.
Time Frame
12 months
Title
Burden of Coronary Artery Disease
Description
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.
Time Frame
12 months
Title
Medication adherence
Description
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.
Time Frame
12 months
Title
Patients self-care and disease knowledge
Description
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.
Time Frame
12 months
Title
Smoking status
Description
Difference between intervention and control group in self-reported smoking status
Time Frame
12 months
Title
Depression, anxiety, and stress levels
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults diagnosed with coronary artery disease Fluent in verbal and written Icelandic Capacity to give informed consent Capacity to operate a smartphone Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elias F Gudmundsson, MSc
Phone
+354 543 1000
Email
elias@sidekickhealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Heida B Bragadottir, BSc
Email
heidabirna@sidekickhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David O Arnar, MD, PhD
Organizational Affiliation
National University Hospital of Iceland & University of Iceland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Landspítali University Hospital
City
Reykjavik
ZIP/Postal Code
101
Country
Iceland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brynja Laxdal, MSc
Phone
+354 543 1000
Email
brynjala@landspitali.is
First Name & Middle Initial & Last Name & Degree
Ingibjorg Davidsdottir, BSc
Phone
+354 543 1000
Email
ingibjod@landspitali.is

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

Learn more about this trial

A Digital Care Solution for Coronary Artery Disease Patients

We'll reach out to this number within 24 hrs