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

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ClinicalTrials.gov Identifier: NCT03294512
Recruitment Status : Completed
First Posted : September 27, 2017
Last Update Posted : August 16, 2018
Sponsor:
Collaborator:
Savvysherpa, Inc.
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

Tracking Information
First Submitted Date  ICMJE September 13, 2017
First Posted Date  ICMJE September 27, 2017
Last Update Posted Date August 16, 2018
Actual Study Start Date  ICMJE September 28, 2017
Actual Primary Completion Date May 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2017)
The number of patients utilizing the app. [ Time Frame: 3 months ]
Data will be collected that shows the number of patients engaging with the app.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03294512 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform
Official Title  ICMJE Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform (iMAWDS Mobile HF Study)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Heart Failure
Intervention  ICMJE Behavioral: MAWDS data entry on app
Utilize the smartphone app to enter their MAWDS (Medication, Activity, Weight, Diet, Symptoms) data
Study Arms  ICMJE Experimental: Heart Failure Patients
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: Behavioral: MAWDS data entry on app
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2017)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 11, 2018
Actual Primary Completion Date May 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03294512
Other Study ID Numbers  ICMJE 1050557
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Intermountain Health Care, Inc.
Study Sponsor  ICMJE Intermountain Health Care, Inc.
Collaborators  ICMJE Savvysherpa, Inc.
Investigators  ICMJE
Principal Investigator: Kirk U Knowlton, MD Intermountain Heart Institute
PRS Account Intermountain Health Care, Inc.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP