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

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ClinicalTrials.gov Identifier: NCT03194841
Recruitment Status : Completed
First Posted : June 21, 2017
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Marva Foster, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Heart failure application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Heart Failure Self-care With the Aid of a Smartphone Application
Actual Study Start Date : August 22, 2016
Actual Primary Completion Date : January 6, 2017
Actual Study Completion Date : January 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Heart Failure Application
A mobile application that allowed for input of physiologic data, qualitative questions about symptoms and education
Other: Heart failure application
A mobile phone application that allowed for input of physiologic data, qualitative question input and education retrieval along with SMS use.




Primary Outcome Measures :
  1. Self-Care of Heart Failure Index (SCHFI) [ Time Frame: two weeks ]
    Measures how well a person monitors their symptoms, adhere to medication/diet and how confident they are in performing self-care.


Secondary Outcome Measures :
  1. Heart Failure Somatic Awareness Scale [ Time Frame: two weeks ]
    It determines the extent of distress associated with heart failure symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194841


Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
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Study Chair: Kristen Sethares, PhD University of Massachusetts, Dartmouth

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Responsible Party: Marva Foster, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03194841     History of Changes
Other Study ID Numbers: 15.064
First Posted: June 21, 2017    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases