Heart FailureNCT02527759
Patient Self Monitoring to Evaluate 30 Day Post Discharge Heart Failure Outcomes
An observational study of Heart Failure, run by Georgetown University at 2 sites in United States.
Trial summary
The purpose of this study is to examine the relative predictive ability of the derived monitoring instrument to determine post discharge instability and 30-day outcomes in patients discharged with HF. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to 30 Aug 2017
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with heart failure
Who may be able to join
- > 65 years of age
- male and female patients admitted to the hospital with the primary diagnosis of HF with hospitalization > 24 hours
- able to read and write in English
- discharged to home environment
Who cannot join
- a cardiac transplant candidate
- experienced an acute coronary event within the previous 30 days of index hospitalization
- experienced percutaneous coronary intervention or coronary artery bypass grafting within the previous 30 days of index hospitalization
- end stage renal disease/hemodialysis
- have a left ventricular assist device
- > 400 lbs
- unable to stand for 90 seconds independently
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medstar, Washington Hospital Center
Washington D.C., District of Columbia, 20010
Medstar, Georgetown University Hospital
Washington D.C., District of Columbia, 20057
About this study
The purpose of this study is to examine the relative predictive ability of the derived monitoring instrument to determine post discharge instability and 30-day outcomes in patients discharged with HF. The primary hypothesis is that variables in the monitoring instrument, individually and combined, identify risk for 30-day outcomes. Clinical indicators of dyspnea, fatigue, orthopnea, dyspnea with exertion, daily weight, edema, heart rate, blood pressure, mental condition, medication adherence, and overall well-being will be reported by participants on a daily basis and considered indicators for 30-day outcomes of stability, re-hospitalization, or mortality.
- Conditions
- Heart Failure
- Being tested
- Survey
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events of rehospitalization and/or mortality.
Trial a novel 30-day post-discharge monitoring instrument after hospitalization for heart to evaluate patient status based on patient self-monitoring.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startJan 2016
- Primary completionAug 2017
- Study completion30 Aug 2017
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.
- More trials run by Georgetown UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527759
- Sponsor's protocol ID
- 2015-0336
- Status last verified
- Dec 2016
- First submitted
- 14 Apr 2015
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to make individual participant data available.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Self Monitoring to Evaluate 30 Day Post Discharge Heart Failure Outcomes
- ClinicalTrials.gov ID
- NCT02527759
- Acronym / sponsor ID
- 2015-0336
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 19 Aug 2015 (estimated)
- 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 examine the relative predictive ability of the derived monitoring instrument to determine post discharge instability and 30-day outcomes in patients discharged with HF. The primary hypothesis is that variables in the monitoring instrument, individually and combined, identify risk for 30-day outcomes. Clinical indicators of dyspnea, fatigue, orthopnea, dyspnea with exertion, daily weight, edema, heart rate, blood pressure, mental condition, medication adherence, and overall well-being will be reported by participants on a daily basis and considered indicators for 30-day outcomes of stability, re-hospitalization, or mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with heart failure
Key inclusion criteria (4 listed)
- > 65 years of age
- male and female patients admitted to the hospital with the primary diagnosis of HF with hospitalization > 24 hours
- able to read and write in English
- discharged to home environment
Key exclusion criteria (7 listed)
- a cardiac transplant candidate
- experienced an acute coronary event within the previous 30 days of index hospitalization
- experienced percutaneous coronary intervention or coronary artery bypass grafting within the previous 30 days of index hospitalization
- end stage renal disease/hemodialysis
- have a left ventricular assist device
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 |
|---|---|---|
| Survey | Behavioural | – |
Primary outcome
Number of participants with adverse events of rehospitalization and/or mortality.
Time frame: 30 days
Trial a novel 30-day post-discharge monitoring instrument after hospitalization for heart to evaluate patient status based on patient self-monitoring.
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 20 Oct 2017.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Georgetown University at 2 sites 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 4 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: finished, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Number of participants with adverse events of rehospitalization and/or mortality. (time frame: 30 days). 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 20 Oct 2017.