Heart FailureI get betterNCT04294303
Use of Telemonitoring System in Heart Failure Patients
A study testing web based telemonitoring system and Conventional in people with Heart Failure and Quality of Life, run by Danbury Hospital at 1 site in United States.
Trial summary
Heart failure is a major public health problem worldwide. Heart failure is one of the most common causes for hospitalizations among people over 65 years of age in the United States. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Quality of Life
- What is being tested?
- web based telemonitoring system and Conventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2016to 29 Jan 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
- 18 years of age and older
- Admitted to Danbury Hospital with heart failure
- NYHA functional class II-IV
Who cannot join
- Not agreeable to participate in the study
- ESRD on HD
- Severe COPD (O2/steroid dependent?)
- Pregnancy
- Hospice patients/bed bound patients
- Severe valvular disease, or recent valvular intervention (within 1 year) or planned valvular intervention.
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- Expected to be transferred to another acute care hospital
- Solid organ transplant recipient or listed for transplant, recipient of left ventricular assist device or planned to receive one
- Homeless participants
- Active psychiatric disorders, addiction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heart Failure Self-Management Using a Mobile Web-Based Telemonitoring System- Impact on Hospital Readmissions and Quality of Life SELF-e HF
Heart failure is a major public health problem worldwide. Heart failure is one of the most common causes for hospitalizations among people over 65 years of age in the United States. Nationwide, approximately 25% of patients admitted to a hospital for heart failure are readmitted to a hospital within 30 days.Multiple transitional care interventions, including telemonitoring, aimed to decrease hospital readmission rates and improve quality of life in heart failure (HF) patients have been explored. Most studies evaluated effectiveness of telemonitoring used in conjunction with other interventions. In this study, investigators studied the role of a potentially cost-effective, telemonitoring program in reducing readmissions and improving quality of life among patients admitted with HF exacerbation in a teaching hospital. They aimed to determine impact of a standalone telemonitoring system.
Primary outcome: Rate of hospital readmission for heart failure Secondary outcomes: Quality of life, Perceived effect of the intervention on heart-failure related care
Read the detailed description
60 patients will be recruited for this study. After signing the consent form, participant will be randomized to receive usual care (i.e. they will get the current standard care for patients with heart failure) or usual care and participation in the iGetBetter program. Participant will complete a questionnaire in the hospital about their quality of life. iGetBetter group will be given a Bluetooth-equipped scale, blood pressure cuff, and a tablet with a data plan. Participant will check their weight and blood pressure at home daily, using the equipment provided. This information will be sent via the internet to iGetBetter's web server, where the data will be temporarily stored. The data will be monitored by the physician researcher. If their blood pressure is high (e.g. greater than or equal to 140/90 for two days in a row) or they gain a significant amount of weight (e.g. 2 pounds in two days), the study team will be automatically notified. A member of the study team will alert participant cardiologist and the cardiologist will have the option to make any recommendations, such as contacting the subject to schedule an office visit.
Total participation in this study will last 45 days after patient is discharged from the hospital.
Regardless of the assigned group, participant will be asked to complete two questionnaires after 45 days. A member of the research team will contact participant by phone to complete these questionnaires. One of these questionnaires will investigate their quality of life; the other will assess how participant feel the care they have received has affected their health. Patients assigned to the iGetBetter group will also complete a third survey about their satisfaction with the program.
- Conditions
- Heart Failure, Quality of Life
- Being tested
- web based telemonitoring system, Conventional
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web based telemonitoring systemOther
Subjects in the telemonitoring group were given an iPad with installed iHealth application, a scale, and an electronic blood pressure monitor (a mobile web-based telemonitoring system). These devices were interconnected via Bluetooth. The iPad had permanent internet connection. Patients were taught to use the equipment to check and record their weight, blood pressure, and heart rate every morning, for 45 days after the hospital discharge. Data was automatically uploaded via iHealth application in a secure database.
ConventionalOther
Subjects in the control group received the standard patient teaching, including an instruction to self-monitor their weight.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring | Experimental | Subjects were assigned to web based telemonitoring system. Receives: Other: web based telemonitoring system |
| Control | Other | Subjects were assigned to conventional monitoring. Receives: Other: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hospital readmission for heart failure
Measured: 45 days after enrollment
Secondary outcomes (2)
Quality of life: questioninaire
Quality of life based on Minnesota Living with Heart Failure Questionnaire, Range 0-105, from best to worst quality of life. First time given at time of enrollment and then 45 days after enrollment, a member of the research team contacted patient by phone to complete the questionnaire.
Measured: 45 days after enrollment
Perceived effect of the intervention on heart-failure related care
Perceived effect of the intervention on heart-failure related care based on the Perceived effect of telemonitoring questionnaire. 45 days after enrollment, a member of the research team contacted patient by phone to complete the following questions :
- Felt more in the control of the disease
- Felt more connected with the medical team
- Felt that it reminded to take the pills
Each question is answered on the following scale: very true, true, somewhat true, and not true at all.
Measured: 45 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start3 Feb 2016
- Primary completion11 Apr 2018
- Study completion29 Jan 2020
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danbury Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ira Galin, Danbury Hospital
- Investigators
- Ira Galin, MD, Principal investigator, Danbury Hospital, Nuvance Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294303
- Sponsor's protocol ID
- 15-608
- Acronym
- I get better
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2020
- Last updated
- 5 Mar 2020
- 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 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Self-Management Using a Mobile Web-Based Telemonitoring System- Impact on Hospital Readmissions and Quality of Life SELF-e HF
- ClinicalTrials.gov ID
- NCT04294303
- Acronym / sponsor ID
- I get better / 15-608
- Conditions
- Heart Failure, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Danbury HospitalUniversity, hospital or other
- Study start
- 3 Feb 2016 (actual)
- Primary completion
- 11 Apr 2018 (actual)
- Study completion
- 29 Jan 2020 (actual)
- First posted
- 4 Mar 2020 (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.
Heart failure is a major public health problem worldwide. Heart failure is one of the most common causes for hospitalizations among people over 65 years of age in the United States. Nationwide, approximately 25% of patients admitted to a hospital for heart failure are readmitted to a hospital within 30 days.Multiple transitional care interventions, including telemonitoring, aimed to decrease hospital readmission rates and improve quality of life in heart failure (HF) patients have been explored. Most studies evaluated effectiveness of telemonitoring used in conjunction with other interventions. In this study, investigators studied the role of a potentially cost-effective, telemonitoring program in reducing readmissions and improving quality of life among patients admitted with HF exacerbation in a teaching hospital. They aimed to determine impact of a standalone telemonitoring system.
Primary outcome: Rate of hospital readmission for heart failure Secondary outcomes: Quality of life, Perceived effect of the intervention on heart-failure related care
Detailed description
60 patients will be recruited for this study. After signing the consent form, participant will be randomized to receive usual care (i.e. they will get the current standard care for patients with heart failure) or usual care and participation in the iGetBetter program. Participant will complete a questionnaire in the hospital about their quality of life. iGetBetter group will be given a Bluetooth-equipped scale, blood pressure cuff, and a tablet with a data plan. Participant will check their weight and blood pressure at home daily, using the equipment provided. This information will be sent via the internet to iGetBetter's web server, where the data will be temporarily stored. The data will be monitored by the physician researcher. If their blood pressure is high (e.g. greater than or equal to 140/90 for two days in a row) or they gain a significant amount of weight (e.g. 2 pounds in two days), the study team will be automatically notified. A member of the study team will alert participant cardiologist and the cardiologist will have the option to make any recommendations, such as contacting the subject to schedule an office visit.
Total participation in this study will last 45 days after patient is discharged from the hospital.
Regardless of the assigned group, participant will be asked to complete two questionnaires after 45 days. A member of the research team will contact participant by phone to complete these questionnaires. One of these questionnaires will investigate their quality of life; the other will assess how participant feel the care they have received has affected their health. Patients assigned to the iGetBetter group will also complete a third survey about their satisfaction with the program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | Experimental | Other: web based telemonitoring systemSubjects were assigned to web based telemonitoring system. |
| Control | Other | Other: ConventionalSubjects were assigned to conventional monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older
- Admitted to Danbury Hospital with heart failure
- NYHA functional class II-IV
Key exclusion criteria (10 listed)
- Not agreeable to participate in the study
- ESRD on HD
- Severe COPD (O2/steroid dependent?)
- Pregnancy
- Hospice patients/bed bound patients
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 |
|---|---|---|
| web based telemonitoring systemSubjects in the telemonitoring group were given an iPad with installed iHealth application, a scale, and an electronic blood pressure monitor (a mobile web-based telemonitoring system). These devices were interconnected via Bluetooth. The iPad had permanent internet connection. Patients were taught to use the equipment to check and record their weight, blood pressure, and heart rate every morning, for 45 days after the hospital discharge. Data was automatically uploaded via iHealth application in a secure database. | Other | Telemonitoring |
| ConventionalSubjects in the control group received the standard patient teaching, including an instruction to self-monitor their weight. | Other | Control |
Primary outcome
Rate of hospital readmission for heart failure
Time frame: 45 days after enrollment
2 secondary outcomes
Quality of life: questioninaire
Time frame: 45 days after enrollment
Perceived effect of the intervention on heart-failure related care
Time frame: 45 days after enrollment
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 5 Mar 2020.
- 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.
Ira Galin, MD principal investigator
Danbury Hospital, Nuvance Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing web based telemonitoring system and Conventional in people with Heart Failure and Quality of Life, run by Danbury Hospital 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 10 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 5 Mar 2020. 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?
Rate of hospital readmission for heart failure (time frame: 45 days after enrollment). 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 5 Mar 2020.