Use of mHealth to Increase Physical Activity for Patients Recently Hospitalized With Acute Heart Failure

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Behavioral: mHealth Intervention

• Registration Number: NCT04848298
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

The aim of this trial is to determine if a mobile application that promotes physical exercise in the follow-up of patients recently hospitalized with acute heart failure can improve exercise capacity after 6 months and physical activity levels compared to the standard follow-up.

A randomized clinical trial will be conducted with 100 consecutive patients aged +18 years, hospitalized for acute decompensated heart failure in a tertiary referral hospital who own a mobile phone compatible with MyPlan and access to Wi-Fi or mobile data. At discharge, patients will be randomly assigned in two groups; the intervention group will be followed with a smartphone application to promote physical activity, whereas the control group will take responsibility in their adherence to exercise recommendations. Main study variables will be functional capacity after 6 months, which will be evaluated using the six minute walking test, and physical activity levels, using the International Physical Activity Questionnaire (IPAQ). The study will be analyzed using the intention-to-treat principle. The project has been authorized by the local committee for ethics in clinical research.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-08
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-19
• Study Start: 2021-04-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-20
• Primary Completion: 2023-10-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• Aged +18 years
• Hospitalized for acute decompensated heart failure in a tertiary referral hospital
• Owning a mobile phone compatible with MyPlan and access to Wi-Fi or mobile data (either the patient or the caregiver)

Exclusion Criteria

• NYHA IV patients
• Currently listed for heart transplant
• Left ventricular assist device recipient
• Ventricular arrhythmia within prior 6 months
• Uncontrolled arterial hypertension or resting heart rate >100 bpm
• Acute myocarditis or pericarditis
• Severe aortic stenosis
• Hypertrophic obstructive cardiomyopathy
• Advanced AV block
• Muscle-skeletal or neurologic disease preventing to perform study procedures
• ACS within prior month
• Severe lung disease
• Moderate or severe cognitive impairment
• Unable/unwilling to consent
• Projected life expectancy <6 months
• Clinical judgment concerning other safety issues

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile Health Arm	mHealth Intervention	-

Primary Outcome Measures

Name	Time	Method
Change in 6-minute walking distance (6MWD)	6 months

Secondary Outcome Measures

Name	Time	Method
Participant reported physical activity levels, using the International Physical Activity Questionnaire (IPAQ)	6 months	Results will be reported in categories (low activity levels, moderate activity levels or high activity levels) and as a continuous variable (MET minutes a week)

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain