A Digital Solution for Patients With Heart Failure

NCT ID: NCT05193344

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2023-12-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Digital solution group

Participants will be instructed to download a remote symptom monitoring and lifestyle-changing mobile application to which they will have access for 12 months. The program aims to provide remote symptom monitoring by having participants enter data (on diet, exercise, weight, etc) and answer questionnaires via the SidekickHealth platform, and to empower positive lifestyle changes. Beyond this, all patients in the interventional arm will also receive standard of care as defined below for the control arm.

Group Type: EXPERIMENTAL

A digital care solution for patients with Heart Failure

Intervention Type: DEVICE

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.

Standard of Care for patients with Heart Failure

Intervention Type: OTHER

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.

Standard of care - control group

All participants in the control arm will receive 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. After the baseline measurements and data collection, there will be scheduled visits to a health care provider at 3, 6, and 12 months.

Group Type: ACTIVE_COMPARATOR

Standard of Care for patients with Heart Failure

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults with confirmed congestive HF registered at the outpatient heart failure clinic at the Landspitali University Hospital
• Participants should be on one of these medications for heart failure treatment: angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blocker (ARB) inhibitors, or Angiotensin Receptor-Neprilysin Inhibitor
• Participants with all stages of HF will be included (NYHA classes I-IV)
• Started their medical HF treatment at least 1 month prior to study enrollment
• Participants should be willing and able to comply with study procedures and attend the scheduled visits
• Capacity to consent to informed consent

Exclusion Criteria

• HF due to reversible causes (e.g., myocarditis) or severe aortic valve stenosis
• Not owning a smartphone compatible with the Sidekick Health digital solution
• Not knowing how to operate a smartphone
• Moderate to severe dementia
• Unable to understand written and verbal instructions in Icelandic.
• estimated Glomerular Filtration Rate (eGFR) <15 ml/min
• Planned dialysis in the next 6 months
• Planned cardiac transplant surgery
• Active drug/alcohol abuse
• Other serious illness (e.g., cancer, endocarditis)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Landspitali University Hospital

OTHER

Sponsor Role: collaborator

Sidekick Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Landspitali University Hospital

Reykjavik, , Iceland

Countries

Iceland

Other Identifiers

SK-HF-99-002

Identifier Type: -

Identifier Source: org_study_id