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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-22

Study Completion Date

2024-06-10

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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mobile Health Arm

Group Type EXPERIMENTAL

mHealth Intervention

Intervention Type BEHAVIORAL

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.

Control Arm

The Control Arm will receive standard of care including tailored prescription of physical activity

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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mHealth Intervention

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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No