Heart FailureNCT01141907
Nurse-Led Heart Failure Care Transition Intervention for African Americans: The Navigator Program
A study testing Heart Failure Self Care Support and Usual heart failure care in people with Heart Failure, run by Johns Hopkins University at 1 site in United States.
Trial summary
Heart failure (HF) affects over 5 million Americans with HF morbidity reaching epidemic proportions. Annual rates of new and recurrent HF events including hospitalization and mortality are higher among African Americans. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Heart Failure Self Care Support and Usual heart failure care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hospitalized with admitting diagnosis of heart failure in prior 8 weeks
- self-identified as African American
- community-dwelling (i.e., not in a long-term care facility)
- residence within a predefined radius in Baltimore City
- working telephone in their home
- provide signed informed consent
Who cannot join
- cannot speak or understand English
- severe renal insufficiency requiring dialysis
- acute myocardial infarction within preceding 30 days
- receiving home care services for HF post discharge
- legally blind or have major hearing loss
- screen positive for cognitive impairment on the Mini-cog at baseline
Show all 10Show fewer
- unable to stand independently on a weight scale (limited ability to participate in HAT system)
- weigh more than 325 pounds (exceed scale capacity)
- serious or terminal condition such as psychosis or cancer (actively receiving chemo or radiation)
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse-Led Heart Failure Care Transition Intervention for African Americans
Heart failure (HF) affects over 5 million Americans with HF morbidity reaching epidemic proportions. Annual rates of new and recurrent HF events including hospitalization and mortality are higher among African Americans. In this study, the investigators are testing an interdisciplinary model for heart failure care, with focus on enhancing self management and use of telehealth, which has significant potential to improve self management and outcomes.
The main purpose of this study is to learn how to help African Americans with heart failure care for themselves at home. We hope to find out if a team including a nurse and community health navigator using a computer telehealth device can help people with heart failure stay healthier. The team will help people with heart failure to manage their medication, monitor their symptoms and weigh themselves every day after they leave the hospital. The team will also help people with heart failure learn to solve problems that may keep them from following their treatment plan.
- Conditions
- Heart Failure
- Being tested
- Heart Failure Self Care Support, Usual heart failure care
- Keywords
- heart failure, self care, decision support, telemonitoring, navigator
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Failure Self Care SupportBehavioural
The intervention is aimed at preventing HF exacerbations and hospitalizations by improving self management with the support of the Home Automated Telemonitoring (HAT) system. The intervention was delivered by a RN-community health navigator (CHN) team over three months to HF patients and their caregivers in their home and via telephone and HAT system. The intervention was initiated during the index hospitalization. The RN-CHN team collaborated with participants, caregivers, and their usual source of HF care. Intervention strategies included tracking of weight and HF symptoms to provide feedback regarding self management and plan of care, enhancing medication and symptom self management, promoting HF care follow up, and promoting communication with providers.
Usual heart failure careOther
Participants assigned to usual care are treated by their usual source of HF care in the usual manner and in accordance with the American College of Cardiology/American Heart Association Guidelines for the management of HF. Usual care for HF patients admitted to Johns Hopkins Hospital also includes the following: 1) Referral to HF clinic if the patient has no usual source of care and 2) HF patient education booklet.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Self Care Support | Experimental | The goal of the Heart Failure Self Care Support Intervention (Navigator Program), delivered by a nurse and community health navigator team over 3 months post discharge from the index hospitalization, was to improve care transitions by providing patients with tools and support that promote knowledge and skills for HF self care as they transition from hospital to home. The multifaceted Navigator Intervention included the following intervention components: HF home automated telemonitoring support, medication and symptom self management, patient-centered record, HF care follow up, and activation of key supporter. Receives: Behavioral: Heart Failure Self Care Support |
| Usual Heart Failure Care | Active comparator | Usual care for HF patients included the following: 1) Referral to HF clinic if the patient has no usual source of HF outpatient care, 2) HF patient education by HF care coordinator (advanced practice nurse), and 3) HF self care guide. All participants were treated by their usual source of HF care in the usual manner. Receives: Other: Usual heart failure care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalization
Rehospitalization with primary diagnosis of heart failure
Measured: 3 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Cheryl R Dennison, PhD, Principal investigator, Johns Hopkins University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141907
- Sponsor's protocol ID
- R21NR011056
- Other IDs
- R21NR011056
- Status last verified
- Jan 2019
- First submitted
- 26 May 2010
- Last updated
- 19 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Led Heart Failure Care Transition Intervention for African Americans
- ClinicalTrials.gov ID
- NCT01141907
- Acronym / sponsor ID
- R21NR011056
- Conditions
- Heart Failure
- Keywords
- heart failure, self care, decision support, telemonitoring, navigator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Feb 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Posted 19 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart failure (HF) affects over 5 million Americans with HF morbidity reaching epidemic proportions. Annual rates of new and recurrent HF events including hospitalization and mortality are higher among African Americans. In this study, the investigators are testing an interdisciplinary model for heart failure care, with focus on enhancing self management and use of telehealth, which has significant potential to improve self management and outcomes.
The main purpose of this study is to learn how to help African Americans with heart failure care for themselves at home. We hope to find out if a team including a nurse and community health navigator using a computer telehealth device can help people with heart failure stay healthier. The team will help people with heart failure to manage their medication, monitor their symptoms and weigh themselves every day after they leave the hospital. The team will also help people with heart failure learn to solve problems that may keep them from following their treatment plan.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Self Care Support | Experimental | Behavioral: Heart Failure Self Care SupportThe goal of the Heart Failure Self Care Support Intervention (Navigator Program), delivered by a nurse and community health navigator team over 3 months post discharge from the index hospitalization, was to improve care transitions by providing patients with tools and support that promote knowledge and skills for HF self care as they transition from hospital to home. The multifaceted Navigator Intervention included the following intervention components: HF home automated telemonitoring support, medication and symptom self management, patient-centered record, HF care follow up, and activation of key supporter. |
| Usual Heart Failure Care | Active comparator | Other: Usual heart failure careUsual care for HF patients included the following: 1) Referral to HF clinic if the patient has no usual source of HF outpatient care, 2) HF patient education by HF care coordinator (advanced practice nurse), and 3) HF self care guide. All participants were treated by their usual source of HF care in the usual manner. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- hospitalized with admitting diagnosis of heart failure in prior 8 weeks
- self-identified as African American
- community-dwelling (i.e., not in a long-term care facility)
- residence within a predefined radius in Baltimore City
- working telephone in their home
Key exclusion criteria (10 listed)
- cannot speak or understand English
- severe renal insufficiency requiring dialysis
- acute myocardial infarction within preceding 30 days
- receiving home care services for HF post discharge
- legally blind or have major hearing loss
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 |
|---|---|---|
| Heart Failure Self Care SupportThe intervention is aimed at preventing HF exacerbations and hospitalizations by improving self management with the support of the Home Automated Telemonitoring (HAT) system. The intervention was delivered by a RN-community health navigator (CHN) team over three months to HF patients and their caregivers in their home and via telephone and HAT system. The intervention was initiated during the index hospitalization. The RN-CHN team collaborated with participants, caregivers, and their usual source of HF care. Intervention strategies included tracking of weight and HF symptoms to provide feedback regarding self management and plan of care, enhancing medication and symptom self management, promoting HF care follow up, and promoting communication with providers. | Behavioural | Heart Failure Self Care Support |
| Usual heart failure careParticipants assigned to usual care are treated by their usual source of HF care in the usual manner and in accordance with the American College of Cardiology/American Heart Association Guidelines for the management of HF. Usual care for HF patients admitted to Johns Hopkins Hospital also includes the following: 1) Referral to HF clinic if the patient has no usual source of care and 2) HF patient education booklet. | Other | Usual Heart Failure Care |
Primary outcome
Rehospitalization
Time frame: 3 months post enrollment
Rehospitalization with primary diagnosis of heart failure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Cheryl R Dennison, PhD principal investigator
Johns Hopkins University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Failure Self Care Support and Usual heart failure care in people with Heart Failure, run by Johns Hopkins University 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 6 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 19 Feb 2019. 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?
Yes. Results are posted in the registry (first posted 19 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rehospitalization (time frame: 3 months post 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 19 Feb 2019.