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

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

116

Conditions

Heart Failure

Interventions

mHealth InterventionBEHAVIORAL

The Mobile Health Arm will receive standard of care including tailored prescription of physical activity as well as the mobile health intervention, which will have the following features: * Goal setting for frequency and duration of exercise sessions * Graphic feedback and reinforcement with educational and motivational messages tailored to user's exercise adherence. * Problem-solving support * Library with educational tips and information regarding physical exercise.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in 6-minute walking distance (6MWD)

Time frame: 6 months

Secondary Outcomes

Participant reported physical activity levels, using the International Physical Activity Questionnaire (IPAQ)

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)