Congestive Heart FailureCHFNCT03234088
Congestive Heart Failure Pilot Study Utilizing Wireless Home Scale and Daily Symptom Monitoring
A study testing Daily weight measured by digital scale and symptom reporting in people with Congestive Heart Failure, run by University of Pennsylvania at 1 site in United States.
Trial summary
As the population ages and medicine advances, there has been a significant shift to the management of chronic diseases. Most chronic diseases are managed using evidence based consensus guidelines but clinician and patient compliance with these guidelines is sub-optimal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Daily weight measured by digital scale and symptom reporting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Aug 2012
- 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
- Primary diagnosis of heart failure (either systolic or diastolic) NYHA class II, III and IV
- Physical and cognitive ability to use the device
- Cellular phone or other portable device with "text" communication capability or daily access to the internet using a computer or laptop
Who cannot join
- Subject with life expectancy less than 6 months from any cause, or enrolled in hospice care.
- Subject not competent or unwilling to give voluntary informed consent.
- Subject currently participating in another home telemedicine intervention trial
- Subjects with a left ventricular assist device or who have had a cardiac transplant
- Dialysis upon screening or creatinine >2.5
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Home Based Health Monitoring for Congestive Heart Failure Pilot
As the population ages and medicine advances, there has been a significant shift to the management of chronic diseases. Most chronic diseases are managed using evidence based consensus guidelines but clinician and patient compliance with these guidelines is sub-optimal. In addition, due to the nature of chronic diseases, patients need to make long-term lifestyle changes in order to effectively control their disease in order to minimize complications, disability and cost. It is these two factors, consistent implementation of evidence-based guidelines and supporting patients in a way that encourages self-management and lifestyle change, that disease management attempts to impact. There are areas of design, implementation, testing and final-result-reporting to the patient and clinician that require collaboration among information technology (IT) and software design engineers and clinicians to achieve several goals:
- Ensure patient safety.
- Protect the security and integrity of clinical data.
- Provide patient specific education to promote self-management.
- Provide actionable data to clinicians in order to improve clinical care and minimize the risk of adverse events.
- Provide both patient and clinician satisfaction with the system of care.
In order to achieve these goals, testing and development of home technology under a controlled clinical trial is critical.
Read the detailed description
This study will consist of: Specific Aim 1, Perform a pilot study to evaluate the initial performance of the wireless scale and symptom monitoring system on a select number of presumed normal volunteers (five). The purpose of this will be to determine design and process changes prior to the use of the device in subjects with chronic heart failure (HF). The investigators will have each normal volunteer (all part of the key research team) perform scenarios to test the performance of the system. Specific Aim 2 will incorporate changes into the prototype system adapting both the technology as well as the clinical workflows surrounding its use based on the information collected in Specific Aim 1. Specific Aim 3 will evaluate the revised system enrolling 40 volunteer subjects that have provided written voluntary consent with the documented primary diagnosis of HF (systolic or diastolic) to participate in the intervention over a 4-month period with the primary outcome measure being reduction in HF related ER visit or hospitalization.
The objective of this study is to pilot test and refine a new home-based telemedicine health monitoring system that provides wireless, low cost measurement of body weight as well as self-reported responses, including symptoms and medication compliance for the purpose of managing chronic heart failure (HF) within the home. This pilot will test the functionality of the research infrastructure first on 5 healthy volunteers and then on 40 patients with heart failure over 4 months, testing the receipt of accurate input from the wireless scale and then assessing the effectiveness of the scale intervention in reducing ER visits and hospitalizations.
- Conditions
- Congestive Heart Failure
- Being tested
- Daily weight measured by digital scale and symptom reporting
- Keywords
- Congestive Heart Failure, Heart Failure, Home telemonitoring, Telehealth, HF Disease Management, Heart failure remote self management
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily weight measured by digital scale and symptom reportingBehavioural
Also called MedApps Healthcom wireless digital scale is being utilized
All subjects will be provided the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Home HF monitoring | Other | Digital scale readings are transmitted wirelessly to the handheld device. Patients will remotely log on to a secure server to answer daily symptom questions. Patients will complete surveys after voluntarily completing the informed consent process and at study closeout. Receives: Behavioral: Daily weight measured by digital scale and symptom reporting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage of home-health monitoring devices for weight
Monitoring daily weights and heart failure symptoms
Measured: Baseline through study completion, an average of four months
Secondary outcomes (2)
Patient and Provider Questionnaires on usability and functionality of the study's online web portal (Way to Health)
Measured: Baseline through study completion, an average of four months
Patient and Provider Questionnaires on usability and functionality of the study's wifi-enabled home health monitoring devices
Measured: Baseline through study completion, an average of four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study startApr 2011
- Primary completionAug 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee R Goldberg, MD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234088
- Sponsor's protocol ID
- RC2AG036592
- Acronym
- CHF
- Status last verified
- Jul 2017
- First submitted
- 21 Jan 2011
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Based Health Monitoring for Congestive Heart Failure Pilot
- ClinicalTrials.gov ID
- NCT03234088
- Acronym / sponsor ID
- CHF / RC2AG036592
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive Heart Failure, Heart Failure, Home telemonitoring, Telehealth, HF Disease Management, Heart failure remote self management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 31 Jul 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.
As the population ages and medicine advances, there has been a significant shift to the management of chronic diseases. Most chronic diseases are managed using evidence based consensus guidelines but clinician and patient compliance with these guidelines is sub-optimal. In addition, due to the nature of chronic diseases, patients need to make long-term lifestyle changes in order to effectively control their disease in order to minimize complications, disability and cost. It is these two factors, consistent implementation of evidence-based guidelines and supporting patients in a way that encourages self-management and lifestyle change, that disease management attempts to impact. There are areas of design, implementation, testing and final-result-reporting to the patient and clinician that require collaboration among information technology (IT) and software design engineers and clinicians to achieve several goals:
- Ensure patient safety.
- Protect the security and integrity of clinical data.
- Provide patient specific education to promote self-management.
- Provide actionable data to clinicians in order to improve clinical care and minimize the risk of adverse events.
- Provide both patient and clinician satisfaction with the system of care.
In order to achieve these goals, testing and development of home technology under a controlled clinical trial is critical.
Detailed description
This study will consist of: Specific Aim 1, Perform a pilot study to evaluate the initial performance of the wireless scale and symptom monitoring system on a select number of presumed normal volunteers (five). The purpose of this will be to determine design and process changes prior to the use of the device in subjects with chronic heart failure (HF). The investigators will have each normal volunteer (all part of the key research team) perform scenarios to test the performance of the system. Specific Aim 2 will incorporate changes into the prototype system adapting both the technology as well as the clinical workflows surrounding its use based on the information collected in Specific Aim 1. Specific Aim 3 will evaluate the revised system enrolling 40 volunteer subjects that have provided written voluntary consent with the documented primary diagnosis of HF (systolic or diastolic) to participate in the intervention over a 4-month period with the primary outcome measure being reduction in HF related ER visit or hospitalization.
The objective of this study is to pilot test and refine a new home-based telemedicine health monitoring system that provides wireless, low cost measurement of body weight as well as self-reported responses, including symptoms and medication compliance for the purpose of managing chronic heart failure (HF) within the home. This pilot will test the functionality of the research infrastructure first on 5 healthy volunteers and then on 40 patients with heart failure over 4 months, testing the receipt of accurate input from the wireless scale and then assessing the effectiveness of the scale intervention in reducing ER visits and hospitalizations.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home HF monitoring | Other | Behavioral: Daily weight measured by digital scale and symptom reportingDigital scale readings are transmitted wirelessly to the handheld device. Patients will remotely log on to a secure server to answer daily symptom questions. Patients will complete surveys after voluntarily completing the informed consent process and at study closeout. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary diagnosis of heart failure (either systolic or diastolic) NYHA class II, III and IV
- Physical and cognitive ability to use the device
- Cellular phone or other portable device with "text" communication capability or daily access to the internet using a computer or laptop
Key exclusion criteria (5 listed)
- Subject with life expectancy less than 6 months from any cause, or enrolled in hospice care.
- Subject not competent or unwilling to give voluntary informed consent.
- Subject currently participating in another home telemedicine intervention trial
- Subjects with a left ventricular assist device or who have had a cardiac transplant
- Dialysis upon screening or creatinine >2.5
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 |
|---|---|---|
| Daily weight measured by digital scale and symptom reportingAlso: MedApps Healthcom wireless digital scale is being utilizedAll subjects will be provided the intervention. | Behavioural | Home HF monitoring |
Primary outcome
Usage of home-health monitoring devices for weight
Time frame: Baseline through study completion, an average of four months
Monitoring daily weights and heart failure symptoms
2 secondary outcomes
Patient and Provider Questionnaires on usability and functionality of the study's online web portal (Way to Health)
Time frame: Baseline through study completion, an average of four months
Patient and Provider Questionnaires on usability and functionality of the study's wifi-enabled home health monitoring devices
Time frame: Baseline through study completion, an average of four months
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 31 Jul 2017.
- Caveat emptor: the need for evidence, regulation, and certification of home telehealth systems for the management of chronic conditions.Link provided by the sponsor.
- Randomized trial of a daily electronic home monitoring system in patients with advanced heart failure: the Weight Monitoring in Heart Failure (WHARF) trial.Link provided by the sponsor.
- Validation of prognostic models among patients with advanced heart failure.Link provided by the sponsor.
- Electronic and telemedicine techniques to manage heart failure.Link provided by the sponsor.
- Baseline differences in the HF-ACTION trial by sex.Link provided by the sponsor.
Related trials for Congestive Heart Failure
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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.
Lee R Goldberg, MD, MPH principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily weight measured by digital scale and symptom reporting in people with Congestive Heart Failure, run by University of Pennsylvania 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 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 31 Jul 2017. 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?
Usage of home-health monitoring devices for weight (time frame: Baseline through study completion, an average of four 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 31 Jul 2017.