search
Back to results

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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MAWDS data entry on app
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Intermountain Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Heart Failure Patients

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 13, 2017
Last Updated
August 15, 2018
Sponsor
Intermountain Health Care, Inc.
Collaborators
Savvysherpa, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03294512
Brief Title
Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform
Acronym
iMAWDS
Official Title
Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform (iMAWDS Mobile HF Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 28, 2017 (Actual)
Primary Completion Date
May 11, 2018 (Actual)
Study Completion Date
May 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intermountain Health Care, Inc.
Collaborators
Savvysherpa, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)
Detailed Description
The Intermountain Heart Institute will collaborate with Savvysherpa Inc to develop a sensor-based digital platform based on MAWDS. (MAWDS is Intermountain's acronym that stands for Medications, Activity, Weight, Diet, Symptoms; used across Intermountain Healthcare to represent the most important concepts and skills to teach heart failure patients) This will be used to deliver simple, home-based interventions via an app on the subject's iPhone. The app will be programmed to send notifications to the subject to enter their MAWDS data and perform a 6-minute walk test at specific time points during the study. Written informed consent will be obtained from each subject prior to participation. A study team member will register eligible subjects as well as assist them with the iPhone and HealthKit set-up and train them on the app usage. Protocol-required information will be obtained from subject's medical records (collected as part of their usual medical care). Subjects will be asked to enter data into the MAWDS iPhone app at specified intervals for a period of 3 months. The data, with the date and time it was entered, will be posted to a study-specific database. Periodically, the MAWDS app will query activity data from HealthKit and post that to the same database. Scheduled notifications will appear in the iPhone's Notification Center, reminding the subject to use the app. To assess subject engagement, the app will collect and store standard usage statistics provided by the iOS (e.g., number of times and duration the app is used per day, number of data entries, etc). The subjects' electronic medical records will be reviewed for a period of 3 months following enrollment, focused on healthcare utilization (e.g., hospital readmissions, mortality, changes in Intermountain HF (heart failure) Risk Score, etc). All information will be made part of the study-specific database. Follow-up phone calls will be done, as needed, within the first 2 weeks after enrollment to remind subjects to activate the app, ensure that the subjects are using the app appropriately, and address any issues noted on monitoring the data collected via the app. Subjects will have no other research-related clinic visits or in-person follow-up evaluations, other than the visit for obtaining informed consent, registration and setting up of the app, and follow-up telephone calls as needed. Upon completion of the study, the app on the subject's iPhone will be disabled and Savvysherpa will disconnect the "backend" data capture. Data will no longer be collected from the subject and his/her medical records will no longer be accessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heart Failure Patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MAWDS data entry on app
Intervention Description
Utilize the smartphone app to enter their MAWDS (Medication, Activity, Weight, Diet, Symptoms) data
Primary Outcome Measure Information:
Title
The number of patients utilizing the app.
Description
Data will be collected that shows the number of patients engaging with the app.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirk U Knowlton, MD
Organizational Affiliation
Intermountain Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs