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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03194841
Other study ID # 15.064
Secondary ID
Status Completed
Phase N/A
First received June 16, 2017
Last updated June 19, 2017
Start date August 22, 2016
Est. completion date January 6, 2017

Study information

Verified date June 2017
Source University of Massachusetts, Worcester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date January 6, 2017
Est. primary completion date January 6, 2017
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Massachusetts, Worcester

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Heart Failure Somatic Awareness Scale It determines the extent of distress associated with heart failure symptoms. two weeks
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