Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform

NCT03294512 | Completed

• 1 other identifier: 1050557
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to create a smartphone app that delivers the educational content of the current Intermountain MAWDS\* program and allows patients to enter and track their MAWDS data within the app; and to determine if a broad-scale project can be conducted within the limits of currently available technology. Information from this study will be used to design a larger study that is powered to assess the association between data obtained via a MAWDS app and heart failure outcomes. (\*MAWDS- Medications, Activity, Weight, Diet, Symptoms)

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• The number of patients utilizing the app.

  Data will be collected that shows the number of patients engaging with the app.

  3 months

Study Arms (1)

Heart Failure Patients

EXPERIMENTAL

Patients who are seen at Intermountain Medical Center with heart failure, based on the Intermountain-specific Heart Failure Identification and Risk Stratification, will be screened for this study. The Principal Investigator and/or his delegate will confirm the presence of heart failure, based on established standard of care criteria for diagnosis.

Behavioral: MAWDS data entry on app

Interventions

MAWDS data entry on app BEHAVIORAL

Utilize the smartphone app to enter their MAWDS (Medication, Activity, Weight, Diet, Symptoms) data

Heart Failure Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \> 18 years of age
• Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures
• Documentation of heart failure of any etiology, using standard of care criteria for diagnosis, and based on clinical assessment of the Principal Investigator and/or his delegate
• Possess (and are comfortable using) an iPhone of appropriate age (model 5S or newer, since these models have a motion coprocessor that can run iOS 8 or later, as needed to run the app)
• Willing and able to comply with the instructions for entering their MAWDS data into the app installed in their iPhones

You may not qualify if:

• Significant and/or severe co-morbidities, as assessed by the Principal Investigator and/or his delegate
• Currently in hospice care or planned discharge to hospice care at home or to a hospice care facility
• Inability to read and/or understand English (Non-English speaking and reading participants will be excluded since the program requires a variety of communications, not all of which have been validated in a language other than English).
• Other conditions that in the opinion of the Principal Investigator and/or Sub-Investigator may increase risk to the subject and/or compromise the quality of the clinical trial
• The Study Clinician(s) determine(s) that the subject is not eligible for participation in this research study

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• Savvysherpa, Inc.: collaborator

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84143, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Kirk U Knowlton, MD

  Intermountain Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 27, 2017
• Study Start: September 28, 2017
• Primary Completion: May 11, 2018
• Study Completion: May 11, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)