Heart Failure Clinical Trial
— iMAWDSOfficial title:
Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform (iMAWDS Mobile HF Study)
NCT number | NCT03294512 |
Other study ID # | 1050557 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 28, 2017 |
Est. completion date | May 11, 2018 |
Verified date | August 2018 |
Source | Intermountain Health Care, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 15 |
Est. completion date | May 11, 2018 |
Est. primary completion date | May 11, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Male or female > 18 years of age 2. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures 3. 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 4. 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) 5. Willing and able to comply with the instructions for entering their MAWDS data into the app installed in their iPhones Exclusion Criteria: 1. Significant and/or severe co-morbidities, as assessed by the Principal Investigator and/or his delegate 2. Currently in hospice care or planned discharge to hospice care at home or to a hospice care facility 3. 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). 4. 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 5. The Study Clinician(s) determine(s) that the subject is not eligible for participation in this research study |
Country | Name | City | State |
---|---|---|---|
United States | Intermountain Medical Center | Murray | Utah |
Lead Sponsor | Collaborator |
---|---|
Intermountain Health Care, Inc. | Savvysherpa, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of patients utilizing the app. | Data will be collected that shows the number of patients engaging with the app. | 3 months |
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