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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
174
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.
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.
Landspitali University Hospital
Reykjavik, Iceland
Effectiveness for patients with HF
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.
Time frame: 12 months
Resource utilization (cost-effectiveness)
Resource utilization (e.g. number of visits over time to the ER, hospital outpatient unit (and hospital visits in general) due to worsening of heart failure at 6 and 12 months.
Time frame: 12 months
Echocardiogram - ejection fraction
Change in ejection fraction (percent value) for patients with Heart Failure with reduced Ejection Fraction (HFrEF) at 6 months.
Time frame: 6 months
Echocardiogram - change in left atrium size
Change in left atrium size for patients with Heart failure with preserved Ejection Fraction (HFpEF) at 6 months.
Time frame: 6 months
HF-specific laboratory values
Change in N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) at 6 months.
Time frame: 6 months
Symptoms of the metabolic syndrome (MetSyn).
Participant number of MetSyn features (0-5) change from baseline to 6 months, compared between groups.
Time frame: 6 months
Cardiorespiratory fitness
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in outcomes on the 6 minute walking test (6MWT) from baseline to 6 months
Time frame: 6 months
HF disease progression classified with NYHA
Compare changes in New York Heart Association (NYHA) classification from baseline to 6 and 12 months. The NYHA classifies heart disease in four classes, I to IV, based on symptoms. Class IV is the most severe heart disease.
Time frame: 12 months
HF disease progression classified with Killip
Compare changes in Killip classification from baseline to 6 and 12 months. Killip classifies acute myocard infarction patients into four classes: class I to IV. Class IV is the most severe case with the highest mortality risk.
Time frame: 12 months
Medication adherence
Compare self-reported medication adherence from baseline to 6 and 12 months, using the eight-item Morisky Medication Adherence Scale (MMAS-8) and electronic health record (EHR) medication refill information.
Time frame: 12 months
Patient self-care
Compare between groups score from the nine-item European Heart Failure Self-care Behaviour (EHFScB-9) scale from baseline to 3 and 6 months. The score on the EHFScB-9 scale can range from a minimum of 9 to a maximum of 45, with higher scores indicating worse self-care.
Time frame: 6 months
Patient disease knowledge
Compare between groups score from a 6-item HF disease-specific knowledge questionnaire, from baseline to 3 and 6 months. The score on the questionnaire can range from a minimum of 6 to a maximum of 30, with higher scores indicating less HF disease specific knowledge.
Time frame: 6 months
Smoking status
Changes in self-reported smoking status, from baseline to 6 months.
Time frame: 6 months
Depression, anxiety, and stress-levels
Changes in outcomes on the 21-item Depression, Anxiety and Stress Scale (DASS-21) from baseline to 3, 6, and 12 months. The DASS-21 consists of three 7-item scales on which the scores range from a minimum of 0 to a maximum of 21, with higher scores indicating higher levels of anxiety, depression, or stress.
Time frame: 12 months