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Using a Connected Application to Maintain Physical Activity After Cardiac Rehabilitation (APA&CO2)

Primary Purpose

Cardiac Rehabilitation, Acute Coronary Syndrome, Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Connected application
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiac Rehabilitation focused on measuring Cardiac Rehabilitation, Acute Coronary Syndrome, Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient participating in cardiac rehabilitation Patient with a smartphone compatible with the application Patient with internet connection Patient having signed the written consent to participate Exclusion Criteria: Patient reluctant or unable to comply with the protocol Pregnant, parturient and nursing mothers Persons deprived of their liberty or under guardianship

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Classic care

    Connected application

    Arm Description

    Home exercise book, personalized advices and development of an individualized project post-cardiac rehabilitation.

    Recording and sharing sessions. Exchanges and interactions with other patients. Participation in three collective challenges.

    Outcomes

    Primary Outcome Measures

    To demonstrate an increase in the percentage of patients respecting at 6 months post-cardiac rehabilitation the recommendations in terms of physical activity
    accelerometer

    Secondary Outcome Measures

    to study within each group the evolution of the level of physical activity between the end of the cardiac rehabilitation.
    questionnaires IPAQ
    to study within each group the evolution of the motivation to physical activity between the end of the cardiac rehabilitation.
    questionnaire EMAPS
    to study the difference in the level of physical activity at 6 months post-cardiac rehabilitation between the two groups
    questionnaires IPAQ
    to study the difference in the motivation to physical activity at 6 months post-cardiac rehabilitation between the two groups
    questionnaire EMAPS
    to describe the maintenance of the physical activity of the two groups according to the seasonality following the end of the cardiac rehabilitation (winter, spring, summer, autumn).
    accelerometer
    to describe the use of the application in the intervention group
    number of recorded sessions
    to describe patient satisfaction in the intervention group
    scale 0-10 (min 0 - max 10)
    to describe the frequency of use of patients in the intervention group to be recorded their sessions
    scale 0-4 (min 0 - max 4)
    to describe the interactions with other users in the intervention group
    scale 0-4 (min 0 -max 4)
    to describe participation in challenges in the intervention group
    scale 0-3 (min 0 - max 3)
    to describe the continued use of the application in the intervention group
    number of recorded sessions
    to describe the continued use of the application in the intervention group
    number of recorded sessions

    Full Information

    First Posted
    November 21, 2022
    Last Updated
    December 2, 2022
    Sponsor
    University Hospital, Angers
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05646849
    Brief Title
    Using a Connected Application to Maintain Physical Activity After Cardiac Rehabilitation
    Acronym
    APA&CO2
    Official Title
    Using a Connected Application to Maintain Physical Activity After Cardiac Rehabilitation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2025 (Anticipated)
    Study Completion Date
    July 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Angers

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Maintaining physical activity after cardiac rehabilitation has a major role in disease progression and patient prognosis. 6 months after the cardiac rehabilitation, we find during a nursing interview that many patients do not maintain regular physical activity. 1 year after cardiac rehabilitation, between 30% and 60% of patients do not maintain the recommendations in terms of physical activity. It is recommended to perform studies evaluating the effectiveness of new technologies in the fight against non-compliance recommendations for physical activity. That is why, study the interest of using an application connected post-cardiac rehabilitation seems necessary to fight against dropouts in terms of physical activity.
    Detailed Description
    The objective is to study compliance with the recommendations, assessed by accelerometer at 6 months post-cardiac rehabilitation within two groups : classic care versus using a connected application.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Rehabilitation, Acute Coronary Syndrome, Heart Failure
    Keywords
    Cardiac Rehabilitation, Acute Coronary Syndrome, Heart Failure

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    208 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Classic care
    Arm Type
    No Intervention
    Arm Description
    Home exercise book, personalized advices and development of an individualized project post-cardiac rehabilitation.
    Arm Title
    Connected application
    Arm Type
    Experimental
    Arm Description
    Recording and sharing sessions. Exchanges and interactions with other patients. Participation in three collective challenges.
    Intervention Type
    Other
    Intervention Name(s)
    Connected application
    Intervention Description
    Recording and sharing sessions. Exchanges and interactions with other patients. Participation in three collective challenges.
    Primary Outcome Measure Information:
    Title
    To demonstrate an increase in the percentage of patients respecting at 6 months post-cardiac rehabilitation the recommendations in terms of physical activity
    Description
    accelerometer
    Time Frame
    at 6 months
    Secondary Outcome Measure Information:
    Title
    to study within each group the evolution of the level of physical activity between the end of the cardiac rehabilitation.
    Description
    questionnaires IPAQ
    Time Frame
    at 6 months
    Title
    to study within each group the evolution of the motivation to physical activity between the end of the cardiac rehabilitation.
    Description
    questionnaire EMAPS
    Time Frame
    at 6 months
    Title
    to study the difference in the level of physical activity at 6 months post-cardiac rehabilitation between the two groups
    Description
    questionnaires IPAQ
    Time Frame
    at 6 months
    Title
    to study the difference in the motivation to physical activity at 6 months post-cardiac rehabilitation between the two groups
    Description
    questionnaire EMAPS
    Time Frame
    at 6 months
    Title
    to describe the maintenance of the physical activity of the two groups according to the seasonality following the end of the cardiac rehabilitation (winter, spring, summer, autumn).
    Description
    accelerometer
    Time Frame
    at 6 months
    Title
    to describe the use of the application in the intervention group
    Description
    number of recorded sessions
    Time Frame
    at 6 months
    Title
    to describe patient satisfaction in the intervention group
    Description
    scale 0-10 (min 0 - max 10)
    Time Frame
    at 6 months
    Title
    to describe the frequency of use of patients in the intervention group to be recorded their sessions
    Description
    scale 0-4 (min 0 - max 4)
    Time Frame
    at 6 months
    Title
    to describe the interactions with other users in the intervention group
    Description
    scale 0-4 (min 0 -max 4)
    Time Frame
    at 6 months
    Title
    to describe participation in challenges in the intervention group
    Description
    scale 0-3 (min 0 - max 3)
    Time Frame
    at 6 months
    Title
    to describe the continued use of the application in the intervention group
    Description
    number of recorded sessions
    Time Frame
    at 12 months
    Title
    to describe the continued use of the application in the intervention group
    Description
    number of recorded sessions
    Time Frame
    at 18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient participating in cardiac rehabilitation Patient with a smartphone compatible with the application Patient with internet connection Patient having signed the written consent to participate Exclusion Criteria: Patient reluctant or unable to comply with the protocol Pregnant, parturient and nursing mothers Persons deprived of their liberty or under guardianship
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marie Gaume
    Phone
    +33241496000
    Email
    unite-recherche-clinique@ch-cholet.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    DRCI CHU Angers
    Phone
    +33241356329
    Email
    drci-promotion-interne@chu-angers.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paul Da Ros Vettoretto
    Organizational Affiliation
    Centre Hospitalier de Cholet
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Using a Connected Application to Maintain Physical Activity After Cardiac Rehabilitation

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