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
About this trial
This is an interventional supportive care trial for Heart Failure
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
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
NCT ID
NCT03194841
First Posted
June 16, 2017
Last Updated
June 19, 2017
Sponsor
University of Massachusetts, Worcester
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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