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Heart Failure Self-care With the Aid of a Smartphone Application (HFSC)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Heart failure application
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure

Eligibility Criteria

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

Inclusion Criteria:

  • living in a non-nursing home setting
  • primary providers of own self-care
  • established diagnosis of heart failure
  • cognitively intact
  • able to speak/write English

Exclusion Criteria:

  • not willing to use a smartphone
  • not exhibiting acute decompensated heart failure symptoms

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Heart Failure Application

    Arm Description

    A mobile application that allowed for input of physiologic data, qualitative questions about symptoms and education

    Outcomes

    Primary Outcome Measures

    Self-Care of Heart Failure Index (SCHFI)
    Measures how well a person monitors their symptoms, adhere to medication/diet and how confident they are in performing self-care.

    Secondary Outcome Measures

    Heart Failure Somatic Awareness Scale
    It determines the extent of distress associated with heart failure symptoms.

    Full Information

    First Posted
    June 16, 2017
    Last Updated
    June 19, 2017
    Sponsor
    University of Massachusetts, Worcester
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03194841
    Brief Title
    Heart Failure Self-care With the Aid of a Smartphone Application
    Acronym
    HFSC
    Official Title
    Heart Failure Self-care With the Aid of a Smartphone Application
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 22, 2016 (Actual)
    Primary Completion Date
    January 6, 2017 (Actual)
    Study Completion Date
    January 6, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Massachusetts, Worcester

    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
    The purpose of this study was the development, and testing of a HF application that was used to provide self-care support to HF patients through a smartphone device. The study appraised current available literature on HF to determine best practices for promoting self-care of HF through direct communication with individuals with HF living at home. For the purpose of this study, smart phone communication was utilized. Smart phone applications allow patients to transmit physiological data, such as weight, blood pressure, heart rate, and symptom data to healthcare providers. Using a secure website, a healthcare worker can access the information and contact the patient via the mobile phone when their data is out of normal range. This study was novel in its approach from what is traditionally offered in that it supported patient self-care decisions by promoting symptom monitoring and offered both tactical and situational skills strategies through at the point education.

    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
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Heart Failure Application
    Arm Type
    Experimental
    Arm Description
    A mobile application that allowed for input of physiologic data, qualitative questions about symptoms and education
    Intervention Type
    Other
    Intervention Name(s)
    Heart failure application
    Intervention Description
    A mobile phone application that allowed for input of physiologic data, qualitative question input and education retrieval along with SMS use.
    Primary Outcome Measure Information:
    Title
    Self-Care of Heart Failure Index (SCHFI)
    Description
    Measures how well a person monitors their symptoms, adhere to medication/diet and how confident they are in performing self-care.
    Time Frame
    two weeks
    Secondary Outcome Measure Information:
    Title
    Heart Failure Somatic Awareness Scale
    Description
    It determines the extent of distress associated with heart failure symptoms.
    Time Frame
    two weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: living in a non-nursing home setting primary providers of own self-care established diagnosis of heart failure cognitively intact able to speak/write English Exclusion Criteria: not willing to use a smartphone not exhibiting acute decompensated heart failure symptoms
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kristen Sethares, PhD
    Organizational Affiliation
    University of Massachusetts Dartmouth
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Heart Failure Self-care With the Aid of a Smartphone Application

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