Heart FailureNCT05193344
A Digital Solution for Patients With Heart Failure
A study testing A digital care solution for patients with Heart Failure in people with Heart Failure, run by Sidekick Health at 1 site in Iceland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- A digital care solution for patients with Heart Failure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteIceland
- Study dates
- 15 Jan 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Planned dialysis in the next 6 months
- Planned cardiac transplant surgery
- Active drug/alcohol abuse
- Other serious illness (e.g., cancer, endocarditis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Digital Solution for Patients With Heart Failure to Improve Disease Management, Lifestyle, and Quality of Life
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.
Read the 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
- Being tested
- A digital care solution for patients with Heart Failure, Standard of Care for patients with Heart Failure
- Keywords
- heart failure, digital intervention, lifestyle change, remote monitoring, clinical outcome, quality of life, digital solution
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A digital care solution for patients with Heart FailureDevice
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 FailureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital solution group | Experimental | 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. Receives: Device: A digital care solution for patients with Heart Failure; Other: Standard of Care for patients with Heart Failure |
| Standard of care - control group | Active comparator | 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. Receives: Other: Standard of Care for patients with Heart Failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (13)
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.
Measured: 12 months
Echocardiogram - ejection fraction
Change in ejection fraction (percent value) for patients with Heart Failure with reduced Ejection Fraction (HFrEF) at 6 months.
Measured: 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.
Measured: 6 months
HF-specific laboratory values
Change in N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) at 6 months.
Measured: 6 months
Symptoms of the metabolic syndrome (MetSyn).
Participant number of MetSyn features (0-5) change from baseline to 6 months, compared between groups.
Measured: 6 months
Cardiorespiratory fitness
Change in outcomes on the 6 minute walking test (6MWT) from baseline to 6 months
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Smoking status
Changes in self-reported smoking status, from baseline to 6 months.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start15 Jan 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center prospective randomized open blinded end-point (PROBE)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sidekick Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Landspitali University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193344
- Sponsor's protocol ID
- SK-HF-99-002
- Status last verified
- May 2022
- First submitted
- 29 Nov 2021
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized individual participant data (IPD) may be shared with other researchers for relevant research purposes following complementary ethical review and approval from the Ethical Review Board.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Solution for Patients With Heart Failure to Improve Disease Management, Lifestyle, and Quality of Life
- ClinicalTrials.gov ID
- NCT05193344
- Acronym / sponsor ID
- SK-HF-99-002
- Conditions
- Heart Failure
- Keywords
- heart failure, digital intervention, lifestyle change, remote monitoring, clinical outcome, quality of life, digital solution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Sidekick HealthIndustry (pharma, biotech, devices)
- Collaborators
- Landspitali University Hospital
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single center prospective randomized open blinded end-point (PROBE)
| Arm | Type | Receives |
|---|---|---|
| Digital solution group | Experimental | Device: A digital care solution for patients with Heart Failure, Other: Standard of Care for patients with Heart FailureParticipants 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. |
| Standard of care - control group | Active comparator | Other: Standard of Care for patients with Heart FailureAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A digital care solution for patients with Heart FailureA 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. | Device | Digital solution group |
| Standard of Care for patients with Heart FailureThe 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. | Other | Digital solution group, Standard of care - control group |
Primary outcome
Effectiveness for patients with HF
Time frame: 12 months
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.
13 secondary outcomes
Resource utilization (cost-effectiveness)
Time frame: 12 months
Echocardiogram - ejection fraction
Time frame: 6 months
Echocardiogram - change in left atrium size
Time frame: 6 months
HF-specific laboratory values
Time frame: 6 months
Symptoms of the metabolic syndrome (MetSyn).
Time frame: 6 months
Cardiorespiratory fitness
Time frame: 6 months
HF disease progression classified with NYHA
Time frame: 12 months
HF disease progression classified with Killip
Time frame: 12 months
Medication adherence
Time frame: 12 months
Patient self-care
Time frame: 6 months
Patient disease knowledge
Time frame: 6 months
Smoking status
Time frame: 6 months
Depression, anxiety, and stress-levels
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No. Anonymized individual participant data (IPD) may be shared with other researchers for relevant research purposes following complementary ethical review and approval from the Ethical Review Board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A digital care solution for patients with Heart Failure in people with Heart Failure, run by Sidekick Health at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness for patients with HF (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.