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

Study Overview
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Brief Summary
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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.

Official Title
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Use of mHealth to Increase Physical Activity for Patients Recently Hospitalized With Acute Heart Failure: a Randomized Clinical Trial

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: mHealth Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Health Arm<br> | Behavioral: mHealth Intervention<br>* 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.<br>|
| No Intervention: Control Arm<br>The Control Arm will receive standard of care including tailored prescription of physical activity | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6-minute walking distance (6MWD) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 months |