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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Heart failure application

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Failure Somatic Awareness Scale	It determines the extent of distress associated with heart failure symptoms.	two weeks

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Investigators: Study Chair: Kristen Sethares, PhD, University of Massachusetts Dartmouth

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2016
• Primary Completion (Actual): January 6, 2017
• Study Completion (Actual): January 6, 2017

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 19, 2017
• First Posted (Actual): June 21, 2017

Study Record Updates

• Last Update Posted (Actual): June 21, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 15.064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No