Heart FailureHF-SMARTNCT03982017
Heart Failure Self-care Mobile Application to Reduce Readmissions Trial
A study testing Mobile Health Technology Platform in people with Heart Failure, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a patient-centered comparative effectiveness feasibility pilot designed to examine an intervention to increase heart failure self-care and symptom recognition. The investigators will randomize 100 participants to receive either usual care at the time of discharge after heart failure admission or a smartphone… 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?
- Mobile Health Technology Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2019to 30 Jul 2020
- 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
- Inpatient admission for acute decompensated heart failure
- Left ventricular systolic or diastolic heart failure
- Owns a smartphone with a data plan
Who cannot join
- Hospice or life expectancy less than 6 months
- Palliative inotrope use
- Heart transplant listed, or status post transplant
- Ventricular assist devise present, or awaiting placement
- Not being discharged to home
- Unable to provide consent or comply with the intervention
- Current enrollment in a remote monitoring/ telehealth program
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
This is a patient-centered comparative effectiveness feasibility pilot designed to examine an intervention to increase heart failure self-care and symptom recognition. The investigators will randomize 100 participants to receive either usual care at the time of discharge after heart failure admission or a smartphone application that enhances self-care.
- Conditions
- Heart Failure
- Being tested
- Mobile Health Technology Platform, Usual care
- Keywords
- readmission, quality of life, self-care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health Technology PlatformOther
Also called Smartphone Program
When the participant navigates to the program, s/he will follow the directions on how to use the program, sign the terms of agreement, put in a password and begin the welcome page. The participant will receive daily prompts to complete brief questionnaires and review specialized content.
Usual careOther
Routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | Consists of routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant. Receives: Other: Usual care |
| Application | Experimental | Participants will be provided a special link to navigate to the online content and resources. Receives: Other: Mobile Health Technology Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of participants readmitted within 30 days
30-day readmission rate as determined by participant report or medical record query
Measured: 30 days post index discharge
Percent of participants readmitted within 90 days
90-day readmission rate as determined by participant report or medical record query
Measured: 90 days post index discharge
Time to readmission
time to readmission
Measured: from the date of enrollment until the date of first documented admission or date of death from any cause, whichever comes first, assessed up to 90 days
Kansas City Cardiomyopathy Questionnaire at 30 days post enrollment
Quality of life, subjective level of function
Measured: 30 days post index discharge
Kansas City Cardiomyopathy Questionnaire at 90 days post enrollment
Quality of life, subjective level of function
Measured: 90 days post index discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start12 Jul 2019
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Why it stopped: Patient enrollment was initially suspended due to COVID19 pandemic, then the study was closed due to institutional requirements for clinical trials.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Amber Johnson, University of Pittsburgh
- Investigators
- Amber E Johnson, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982017
- Sponsor's protocol ID
- STUDY18110012
- Other IDs
- K12HS019461
- Acronym
- HF-SMART
- Status last verified
- Aug 2021
- First submitted
- 7 Jun 2019
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnson AE, Routh S, Taylor CN, Leopold M, Beatty K, McNamara DM, Davis EM. Developing and Implementing an mHealth Heart Failure Self-care Program to Reduce Readmissions: Randomized Controlled Trial. JMIR Cardio. 2022 Mar 21;6(1):e33286. doi: 10.2196/33286.
PubMed 35311679
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Self-care Mobile Application to Reduce Readmissions Trial
- ClinicalTrials.gov ID
- NCT03982017
- Acronym / sponsor ID
- HF-SMART / STUDY18110012
- Conditions
- Heart Failure
- Keywords
- readmission, quality of life, self-care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient enrollment was initially suspended due to COVID19 pandemic, then the study was closed due to institutional requirements for clinical trials.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 11 Jun 2019 (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.
This is a patient-centered comparative effectiveness feasibility pilot designed to examine an intervention to increase heart failure self-care and symptom recognition. The investigators will randomize 100 participants to receive either usual care at the time of discharge after heart failure admission or a smartphone application that enhances self-care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: Usual careConsists of routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant. |
| Application | Experimental | Other: Mobile Health Technology PlatformParticipants will be provided a special link to navigate to the online content and resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inpatient admission for acute decompensated heart failure
- Left ventricular systolic or diastolic heart failure
- Owns a smartphone with a data plan
Key exclusion criteria (7 listed)
- Hospice or life expectancy less than 6 months
- Palliative inotrope use
- Heart transplant listed, or status post transplant
- Ventricular assist devise present, or awaiting placement
- Not being discharged to home
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 |
|---|---|---|
| Mobile Health Technology PlatformAlso: Smartphone ProgramWhen the participant navigates to the program, s/he will follow the directions on how to use the program, sign the terms of agreement, put in a password and begin the welcome page. The participant will receive daily prompts to complete brief questionnaires and review specialized content. | Other | Application |
| Usual careRoutine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant. | Other | Usual care |
Primary outcome
Percent of participants readmitted within 30 days
Time frame: 30 days post index discharge
30-day readmission rate as determined by participant report or medical record query
Percent of participants readmitted within 90 days
Time frame: 90 days post index discharge
90-day readmission rate as determined by participant report or medical record query
Time to readmission
Time frame: from the date of enrollment until the date of first documented admission or date of death from any cause, whichever comes first, assessed up to 90 days
time to readmission
Kansas City Cardiomyopathy Questionnaire at 30 days post enrollment
Time frame: 30 days post index discharge
Quality of life, subjective level of function
Kansas City Cardiomyopathy Questionnaire at 90 days post enrollment
Time frame: 90 days post index discharge
Quality of life, subjective level of function
Results and safety
The study was stopped early (reason given: Patient enrollment was initially suspended due to COVID19 pandemic, then the study was closed due to institutional requirements for clinical trials.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Derived from this study: PubMed 35311679Johnson AE, Routh S, Taylor CN, Leopold M, Beatty K, McNamara DM, Davis EM. Developing and Implementing an mHealth Heart Failure Self-care Program to Reduce Readmissions: Randomized Controlled Trial. JMIR Cardio. 2022 Mar 21;6(1):e33286. doi: 10.2196/33286.
- 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.
Amber E Johnson, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health Technology Platform in people with Heart Failure, run by University of Pittsburgh 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 12 Aug 2021. 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 was stopped early (reason given: Patient enrollment was initially suspended due to COVID19 pandemic, then the study was closed due to institutional requirements for clinical trials.). Results are not available in the source record.
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?
Percent of participants readmitted within 30 days (time frame: 30 days post index discharge). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03982017, which also lists 1 linked publication.
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 12 Aug 2021.