A Digital Care Solution for Coronary Artery Disease Patients

NCT05713565 | Completed

• 1 other identifier: SK-121-CAD
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; digital application; lifestyle change; remote monitoring; clinical outcome; quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (6)

• CAD-specific health status

  12 months

• Burden of Coronary Artery Disease

  12 months

• Medication adherence

  12 months

• Patients self-care and disease knowledge

  12 months

• Smoking status

  12 months

Study Arms (2)

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.

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).

Other: Standard of care for patients with Coronary Artery Disease

Interventions

A digital care solution for patients with Coronary Artery Disease DEVICE

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.

Also known as: SK-121

Digital Care Solution group

Standard of care for patients with Coronary Artery Disease OTHER

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.

Digital Care Solution group; Standard of Care - control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidekick Health: lead
• Landspitali University Hospital: collaborator

Study Sites (1)

Landspítali University Hospital

Reykjavik, 101, Iceland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• David O Arnar, MD, PhD

  National University Hospital of Iceland & University of Iceland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded for group assignment at the 6-, and 12-month follow-up visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single center prospective randomized open blinded end-point (PROBE)

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 6, 2023
• Study Start: February 6, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 4, 2025

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)