A Digital Solution for Patients With Heart Failure

NCT05193344 | Unknown

• 1 other identifier: SK-HF-99-002
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

heart failure; digital intervention; lifestyle change; remote monitoring; clinical outcome; quality of life; digital solution

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (13)

• Resource utilization (cost-effectiveness)

  12 months

• Echocardiogram - ejection fraction

  6 months

• Echocardiogram - change in left atrium size

  6 months

• HF-specific laboratory values

  6 months

• Symptoms of the metabolic syndrome (MetSyn).

  6 months

Other Outcomes (3)

• Exploratory Objective: Outcome prediction and validation between in-app and clinical metrics

  12 months

• Exploratory Objective: Predictive value of the disease specific in-app remote symptom monitoring for HF disease progression.

  12 months

• Safety objective: Monitor the safety and any potential adverse effects of the digital solution on patients and outcomes.

  12 months

Study Arms (2)

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.

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.

Other: Standard of Care for patients with Heart Failure

Interventions

A digital care solution for patients with Heart Failure 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.

Digital solution group

Standard of Care for patients with Heart Failure 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.

Digital solution group; Standard of care - control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sidekick Health: lead
• Landspitali University Hospital: collaborator

Study Sites (1)

Landspitali University Hospital

Reykjavik, Iceland

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded for group assignment at the 3, 6, and 12 month follow-up visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single center prospective randomized open blinded end-point (PROBE)

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: January 14, 2022
• Study Start: January 15, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 23, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)