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Heart Failure, CongestivePhase 3REMOTE-HFNCT00415545

Educational Program to Improve Heart Failure Outcomes in Adults Living in Rural Areas

A Phase 3 study testing Fluid Watchers LITE Educational Intervention and Fluid Watchers PLUS Educational Intervention in people with Heart Failure, Congestive, run by University of California, San Francisco at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Heart failure patients living in rural areas usually do not have adequate access to formal heart failure management programs. This study will compare two versions of an educational intervention aimed at improving self-care management techniques among individuals with heart failure who are living in rural areas. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Congestive
What is being tested?
Fluid Watchers LITE Educational Intervention and Fluid Watchers PLUS Educational Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
614 participants
Where
3 sitesUnited States
Study dates
Jan 2007to Jan 2013
Phase
Phase 3
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

  • Hospitalized for heart failure in the 6 months prior to study entry
  • Able to read and write English
  • Lives independently

Who cannot join

  • Current participation in a heart failure management program
  • Impaired cognition
  • Serious co-morbidity

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of California, Davis

    Davis, California, 95817

  • University of Kentucky

    Lexington, Kentucky, 40526

  • Washoe Health Care System

    Reno, Nevada, 89523

Other trials in United States

About this study

Official title: Improving Self Care Behavior and Outcomes in Rural Patients With Heart Failure

Heart failure patients living in rural areas usually do not have adequate access to formal heart failure management programs. This study will compare two versions of an educational intervention aimed at improving self-care management techniques among individuals with heart failure who are living in rural areas.

Read the detailed description

Heart failure is a life-threatening condition in which the heart can no longer pump enough blood to the rest of the body. It is important for individuals with heart failure to closely monitor their symptoms and seek out medical attention when appropriate. Swelling and weight gain are common heart failure symptoms that indicate excess fluid buildup in the body and worsening heart function. Closely monitoring and responding to these symptoms can be a strategic way to prevent heart failure exacerbations. However, many patients ignore symptoms and are reluctant to seek care. Specialized monitoring programs can help heart failure patients to respond more appropriately to their symptoms.

Traditionally, heart failure patients living in rural areas have had limited access to formal monitoring programs. Fluid Watchers is a program designed to help heart failure patients living in rural areas improve self-management of symptoms, specifically excess fluid buildup. The purpose of this study is to compare the effectiveness of two versions of Fluid Watchers at improving the hospitalization and death rates of individuals with heart failure who live in rural areas.

In this 2-year study, 710 participants will be randomly assigned to either the Fluid Watchers LITE program, the Fluid Watchers PLUS program, or a usual care control group. Individuals in both Fluid Watchers groups will attend a one-on-one educational session that will include heart failure counseling and information on self-monitoring and care-seeking strategies. Participants in the PLUS program will receive additional counseling, audio tapes, and follow-up telephone calls on a biweekly basis. All participants will record self-monitoring adherence and contact with healthcare providers. Outcome measures will be assessed during either clinic or home visits at study entry and Months 3, 12, and 24, and will include number of emergency department visits, number of physician visits, heart failure severity, and quality of life.

Being tested
Fluid Watchers LITE Educational Intervention, Fluid Watchers PLUS Educational Intervention
Keywords
Heart Failure, Patient Education
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluid Watchers LITE Educational InterventionBehavioural

    Patients in Fluid Watchers LITE will receive counseling about HF and self-monitoring, and coaching on seeking care. They will receive written material, a diary, a scale and a telephone follow-up to answer any questions they might have about the educational session.

  • Fluid Watchers PLUS Educational InterventionBehavioural

    Patients in Fluid Watchers PLUS will receive counseling about HF and self-monitoring, and coaching on seeking care. They will receive written materials, a diary, a scale, an audio tape of the session and telephone followup. Participants in the PLUS program will receive additional counseling, audio tapes, and follow-up telephone calls on a biweekly basis, as compared to participants in the LITE program.

Study groups in NCT00415545
Study groupRoleWhat they receive
1ExperimentalFluid Watchers LITE program
Receives: Behavioral: Fluid Watchers LITE Educational Intervention
2ExperimentalFluid Watchers PLUS program
Receives: Behavioral: Fluid Watchers PLUS Educational Intervention
3No interventionUsual care control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospitalization for heart failure and cardiac mortality

    Measured: Measured at Year 2

Secondary outcomes (4)

  1. Heart failure-related emergency department visits (without hospitalization)

    Measured: Measured at Year 2

  2. Unplanned physician visits

    Measured: Measured at Year 2

  3. Heart failure severity (New York Heart Association [NYHA] class and brain natriuretic peptide)

    Measured: Measured at Year 2

  4. Quality of life

    Measured: Measured at Year 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Dec 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionJan 2012
  4. Study completionJan 2013

Resources

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 3
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
614 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00415545
Sponsor's protocol ID
423
Other IDs
R01HL083176, R01HL083176-01A1
Acronym
REMOTE-HF
Status last verified
Jun 2013
First submitted
21 Dec 2006
Last updated
7 Jun 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Caldwell MA, Peters KJ, Dracup KA. A simplified education program improves knowledge, self-care behavior, and disease severity in heart failure patients in rural settings. Am Heart J. 2005 Nov;150(5):983. doi: 10.1016/j.ahj.2005.08.005.

    PubMed 16290977

  • Park LG, Dracup K, Whooley MA, McCulloch C, Lai S, Howie-Esquivel J. Sedentary lifestyle associated with mortality in rural patients with heart failure. Eur J Cardiovasc Nurs. 2019 Apr;18(4):318-324. doi: 10.1177/1474515118822967. Epub 2019 Jan 21.

    PubMed 30663898

  • Howie-Esquivel J, Dracup K, Whooley MA, McCulloch C, Jin C, Moser DK, Clark RA, Pelter MM, Biddle M, Park LG. Rapid 5 lb weight gain is not associated with readmission in patients with heart failure. ESC Heart Fail. 2019 Feb;6(1):131-137. doi: 10.1002/ehf2.12370. Epub 2018 Oct 24.

    PubMed 30353706

  • Park LG, Dracup K, Whooley MA, McCulloch C, Jin C, Moser DK, Clark RA, Pelter MM, Biddle M, Howie Esquivel J. Symptom Diary Use and Improved Survival for Patients With Heart Failure. Circ Heart Fail. 2017 Nov;10(11):e003874. doi: 10.1161/CIRCHEARTFAILURE.117.003874.

    PubMed 29158435

  • Wu JR, Moser DK, DeWalt DA, Rayens MK, Dracup K. Health Literacy Mediates the Relationship Between Age and Health Outcomes in Patients With Heart Failure. Circ Heart Fail. 2016 Jan;9(1):e002250. doi: 10.1161/CIRCHEARTFAILURE.115.002250.

    PubMed 26721913

  • Hwang B, Moser DK, Pelter MM, Nesbitt TS, Dracup K. Changes in Depressive Symptoms and Mortality in Patients With Heart Failure: Effects of Cognitive-Affective and Somatic Symptoms. Psychosom Med. 2015 Sep;77(7):798-807. doi: 10.1097/PSY.0000000000000221.

    PubMed 26230482

  • Nesbitt T, Doctorvaladan S, Southard JA, Singh S, Fekete A, Marie K, Moser DK, Pelter MM, Robinson S, Wilson MD, Cooper L, Dracup K. Correlates of quality of life in rural patients with heart failure. Circ Heart Fail. 2014 Nov;7(6):882-7. doi: 10.1161/CIRCHEARTFAILURE.113.000577. Epub 2014 Aug 21.

    PubMed 25146960

  • Dracup K, Moser DK, Pelter MM, Nesbitt TS, Southard J, Paul SM, Robinson S, Cooper LS. Randomized, controlled trial to improve self-care in patients with heart failure living in rural areas. Circulation. 2014 Jul 15;130(3):256-64. doi: 10.1161/CIRCULATIONAHA.113.003542. Epub 2014 May 9.

    PubMed 24815499

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluid Watchers LITE Educational Intervention and Fluid Watchers PLUS Educational Intervention in people with Heart Failure, Congestive, run by University of California, San Francisco at 3 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 3 inclusion and 3 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 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Hospitalization for heart failure and cardiac mortality (time frame: Measured at Year 2). 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 NCT00415545, which also lists 8 linked publications.

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 7 Jun 2013.

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