Heart FailureiMAWDSNCT03294512
Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform
A study testing MAWDS data entry on app in people with Heart Failure, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- MAWDS data entry on app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2017to 11 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform (iMAWDS Mobile HF Study)
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)
Read the 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.
- Conditions
- Heart Failure
- Being tested
- MAWDS data entry on app
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAWDS data entry on appBehavioural
Utilize the smartphone app to enter their MAWDS (Medication, Activity, Weight, Diet, Symptoms) data
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: MAWDS data entry on app |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients utilizing the app.
Data will be collected that shows the number of patients engaging with the app.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start28 Sep 2017
- Primary completion11 May 2018
- Study completion11 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Savvysherpa, Inc.
- Responsible party
- Sponsor
- Investigators
- Kirk U Knowlton, MD, Principal investigator, Intermountain Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294512
- Sponsor's protocol ID
- 1050557
- Acronym
- iMAWDS
- Status last verified
- Aug 2018
- First submitted
- 13 Sep 2017
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform (iMAWDS Mobile HF Study)
- ClinicalTrials.gov ID
- NCT03294512
- Acronym / sponsor ID
- iMAWDS / 1050557
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Savvysherpa, Inc.
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 11 May 2018 (actual)
- Study completion
- 11 May 2018 (actual)
- First posted
- 27 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Patients | Experimental | Behavioral: MAWDS data entry on appPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAWDS data entry on appUtilize the smartphone app to enter their MAWDS (Medication, Activity, Weight, Diet, Symptoms) data | Behavioural | Heart Failure Patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirk U Knowlton, MD principal investigator
Intermountain Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAWDS data entry on app in people with Heart Failure, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients utilizing the app. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.