Heart Failure
Conditions
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.
Interventions
BEHAVIORALmHealth 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.
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 6-minute walking distance (6MWD) | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Readmission rate for Heart Failure | 6 months | — |
| Participant reported time dedicated to exercise recommendations | 6 months | — |
| Number of steps -measured using the built-in smartphone pedometer | 6 months | — |
| Rectus femoris muscle diameter | 6 months | — |
| Physical function measured by the Short Physical Performance Battery score | 6 months | Each task is scored from 0 to 4, with 4 being the best, and a total battery score of 12 points |
| Participant reported quality of life - measured using the Minnesota living with heart failure questionnaire (MLHFQ) | 6 months | Each item is scored in a 6-point Likert Scale (0 to 5), thus the total score could range from 0 to 105, with higher scores indicating more significant impairment in health-related quality of life |
| Muscle strength - measured using the Medical Research Council (MRC) Sum Score | 6 months | The total MRC sum score ranges from 0 (total paralysis) to 60 (normal strength). |
| Upper limb strenght - measured by hand-held dynamometry | 6 months | This instrument is scored using force production in kilograms (0-90) |
| User satisfaction with the mHealth application (only experimental arm), measured by a customer satisfaction survey specifically designed for the trial | 6 months | — |
| NT-proBNP levels | 6 months | — |
Countries
Spain
Outcome results
None listed