NCT03194841

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable heart-failure

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
Last Updated

June 21, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

June 16, 2017

Last Update Submit

June 19, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Heart Failure Somatic Awareness Scale

    two weeks

Study Arms (1)

Heart Failure Application

EXPERIMENTAL

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

Other: Heart failure application

Interventions

A mobile phone application that allowed for input of physiologic data, qualitative question input and education retrieval along with SMS use.

Heart Failure Application

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Kristen Sethares, PhD

    University of Massachusetts Dartmouth

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 21, 2017

Study Start

August 22, 2016

Primary Completion

January 6, 2017

Study Completion

January 6, 2017

Last Updated

June 21, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share