Menu
Peptide Database
Results
No peptides found
Featured

Use search to browse all 100+ peptides

DSIP

Emideltide, DSIP nonapeptide, Delta sleep-inducing peptide

Quick Stats
Studies 458
Trials 82
Unknown NA INTERVENTIONAL NCT05193344

A Digital Solution for Patients With Heart Failure

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Interventions

Name: A digital care solution for patients with Heart Failure
Type: DEVICE
Description: 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.
Name: Standard of Care for patients with Heart Failure
Type: OTHER
Description: 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.

Primary Outcomes

Measure: Effectiveness for patients with HF
TimeFrame: 12 months
Description: Change in HF-induced symptom frequency, physical and social limitations, and quality of life impairment, from baseline to 12 months. This primary outcome will be as measured with the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12). The KCCQ-12 score ranges from a minimum of 0 to a maximum of 100, where 100 is the best possible score indicating no symptoms, no limitations, and an excellent quality of life.

Trial Information

NCT ID

NCT05193344

Status

Unknown

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Sidekick Health

Last Updated

December 15, 2025