A Digital Care Solution for Coronary Artery Disease Patients

NCT05713565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2025-06-04

No results posted yet for this study

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

Interventions

DEVICE

A digital care solution for patients with Coronary Artery Disease

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.

OTHER

Standard of care for patients with Coronary Artery Disease

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.

Sponsors & Collaborators

  • Landspitali University Hospital

    collaborator OTHER
  • Sidekick Health

    lead INDUSTRY

Principal Investigators

  • David O Arnar, MD, PhD · National University Hospital of Iceland & University of Iceland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Iceland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05713565 on ClinicalTrials.gov