NCT05193344

A Digital Solution for Patients With Heart Failure

A Digital Solution for Patients With Heart Failure to Improve Disease Management, Lifestyle, and Quality of Life

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Sidekick Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study aim is to determine whether a 12-month digitally delivered behaviour change solution for patients with heart failure improves symptom frequency, mental health, quality of life, medication adherence, and self-care behaviour. The primary and secondary endpoints will be captured at 6- and 12-months follow-up visits to assess longer term effect on outcomes.

Detailed description

Heart Failure (HF) is one of the most common causes of morbidity and mortality in developed countries with a prevalence rate of 4.2% of the adult population and 11.8% among people ≥60 years of age. Worldwide HF affects about 26 million people and poses a significant burden on healthcare providers and patients. People with HF may have severe symptoms, and some may need a heart transplant or implantation of a ventricular assist device. Important modifiable HF risk factors are smoking, physical inactivity, overweight and obesity, and an unhealthy diet. Lifestyle changes by HF patients are known to reduce HF-related hospital (re)admission, morbidity and mortality. Guideline-directed treatment of HF includes among others pharmacotherapy, implantation of devices, regular exercise, and enrolment in a multidisciplinary care management program. Components of the multidisciplinary care management program are among others: patient education with an emphasis on adherence and self-care, patient involvement in symptom monitoring, and follow-up after discharge (for instance through remote monitoring). Adherence to the recommendations has proven difficult. A digitally delivered solution that provides remote symptom monitoring and lifestyle intervention support may support HF patients to halt or reverse disease progression and improve their quality of life. This study aims to digitally provide remote symptom monitoring and lifestyle intervention via a mobile platform (Sidekick Health) with the primary aim to determine the effectiveness of adding Sidekick Health's digital solution for HF patients to the standard care treatment by changes in the KCCQ-12 scores. The secondary aims are to determine the effect on other clinical outcomes (echocardiograms, biomarkers, metabolic syndrome symptoms, HF disease progression), other health-related outcomes (self-care, medication adherence, cardiorespiratory fitness, disease knowledge, smoking status, and anxiety, depression, and stress-levels), and cost-effectiveness.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	A digital care solution for patients with Heart Failure	A digital solution that provides remote symptom monitoring and support of lifestyle-changes by gamification, altruistic rewards, and engaging content with relevant tasks or missions to be completed.
OTHER	Standard of Care for patients with Heart Failure	The best medical therapy including start or optimization of secondary preventive pharmacotherapy, and advise on modifiable risk factors. The participants in the control arm will also receive an information leaflet about relevant lifestyle modifications for HF.

Timeline

• Start date: 2022-01-15
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2022-01-14
• Last updated: 2023-02-23

Locations

1 site across 1 country: Iceland