Use of mHealth to Increase Physical Activity for Patients Recently Hospitalized With Acute Heart Failure (mRehab)
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
mHealth Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
- Hospital de la Santa Creu i Sant PauRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mobile Health Arm
Control Arm
Arm Description
The Control Arm will receive standard of care including tailored prescription of physical activity
Outcomes
Primary Outcome Measures
Change in 6-minute walking distance (6MWD)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT04848298
First Posted
April 8, 2021
Last Updated
March 17, 2023
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT04848298
Brief Title
Use of mHealth to Increase Physical Activity for Patients Recently Hospitalized With Acute Heart Failure
Acronym
mRehab
Official Title
Use of mHealth to Increase Physical Activity for Patients Recently Hospitalized With Acute Heart Failure: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mobile Health Arm
Arm Type
Experimental
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
The Control Arm will receive standard of care including tailored prescription of physical activity
Intervention Type
Behavioral
Intervention Name(s)
mHealth Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in 6-minute walking distance (6MWD)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Participant reported physical activity levels, using the International Physical Activity Questionnaire (IPAQ)
Description
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)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Muscle strength - measured using the Medical Research Council (MRC) Sum Score
Description
The total MRC sum score ranges from 0 (total paralysis) to 60 (normal strength).
Time Frame
6 months
Title
Upper limb strenght - measured by hand-held dynamometry
Description
This instrument is scored using force production in kilograms (0-90)
Time Frame
6 months
Title
Rectus femoris muscle diameter
Time Frame
6 months
Title
Physical function measured by the Short Physical Performance Battery score
Description
Each task is scored from 0 to 4, with 4 being the best, and a total battery score of 12 points
Time Frame
6 months
Title
Participant reported quality of life - measured using the Minnesota living with heart failure questionnaire (MLHFQ)
Description
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
Time Frame
6 months
Title
NT-proBNP levels
Time Frame
6 months
Title
Readmission rate for Heart Failure
Time Frame
6 months
Title
Participant reported time dedicated to exercise recommendations
Time Frame
6 months
Title
Number of steps -measured using the built-in smartphone pedometer
Time Frame
6 months
Title
User satisfaction with the mHealth application (only experimental arm), measured by a customer satisfaction survey specifically designed for the trial
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Mirabet, Ph. D.
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Mirabet, Ph. D.
Phone
935565958
Email
cardiologia@santpau.cat
12. IPD Sharing Statement
Learn more about this trial
Use of mHealth to Increase Physical Activity for Patients Recently Hospitalized With Acute Heart Failure
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