Monitoring and Self-management of Sleep Fatigue and Dyspnea

June 12, 2020 updated by: University of Massachusetts, Amherst

Monitoring and Self-management of Sleep Fatigue and Dyspnea to Improve Heart Failure Outcomes in African-Americans

African Americans have the highest risk for developing heart failure. When African Americans are diagnosed with heart failure (AAHF) it is usually more advanced HF compared to other races. African-Americans have the highest rate of hospitalization for HF compared to any other ethnic groups. Thus, life style modification, awareness of signs and symptoms of HF by continuous, rather than intermittent monitoring, is essential in beginning to develop HF interventions that can provide early detection. Early interventions would lead to reduced re-hospitalization, prevent hospital readmission and reduce the mortality rate associated with HF.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Symptoms of heart failure due to circulatory fluid overload: Signs of circulatory fluid overload are theleading to cardiac decompensation or worsening heart failure are: orthopnea, dyspnea, fatigue, weight gain, abdominal swelling, fluid retention, extended jugular vein, leg edema, crackles, and ascites. Identifying early signs of CFO in HF would provide patients more time to respond and self-manage symptoms at home.

Currently most HF patients are monitored intermittently for changes in symptoms

. According to the American Heart Association establishing self- monitoring practices is the best method for improving health behaviors and health outcomes in individuals.

Fatigue and sleep in HF and gaps in symptom self-management: Fatigue in heart failure patients was previously measured using a self-reported questionnaire and concluded that identifying fatigue early could result in initiation of treatment to prevent HF decompensation. A study by also concluded that severe HF symptoms are associated with higher levels of fatigue in HF patients. found that increases in fatigue in cardiovascular patients resulted in poorer self-care and poorer cardiovascular outcomes, but fatigue was not an indication of disease severity. . Similarly another study concluded that there is a relationship between sleep, fatigue and functional performance in HF patients. However, sleep, fatigue and HF symptoms were only intermittently, rather than continuously, monitored in these studies to assess its impact on HF patient outcomes.

The wrist-worn wearable device, Readiband (Fatigue Science)has a 93 accuracy rate in measuring sleep. The Readiband and the biomathematical fatigue model SAFTE (Sleep, Activity, Fatigue, and Task Effectiveness)have being successfully used to measure sleep and fatigue in multiple areas of research The Readiband has a one month battery life and has the ability to sync to mobile phones, or iPads via a Sync app. It allows for Minute-by-minute actigraphy values and sleep/wake classification. The Readiband has the ability to track, high recurring wake episodes, frequency of daytime sleep episodes, high sleep latency, wake after sleep onset and total sleep quantity. The Readiband has been used successfully to measure fatigue in athletes and law enforcement officers In the following studies the Readiband was use to assess the correlation between sleep and fatigue: risk for accidents in medical residents risk for making medical errors, and to predict football player's risk for injury Each study has shown some level of statistical significance of the relationship between sleep and fatigue. This study is adding another component of assessing if sleep and fatigue correlates with increase severity of HF symptoms.The SAFTE Fatigue Model (Sleep, Activity, Fatigue, and Task Effectiveness)will interpret the data collected from the Readiband. The SAFTE Fatigue Model and the Readiband has never been use to monitor the correlation between sleep, fatigue and decompensation in HF symptoms. The data from the Readiband will be transmitted to the SAFTE Fatigue model. The data will analyze the patient sleep wake pattern to detect patient's level of fatigue and data will be provided with the patient.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Amherst, Massachusetts, United States, 01003
        • Recruiting
        • University of Massachusetts Amherst
        • Contact:
        • Principal Investigator:
          • Heather Hamilton, PhD RN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Age 30-85years.
  • Diagnosis of heart failure based on patient's medical record.
  • Meets the criteria for New York Heart Failure (NYHF) classification for stage I-III heart failure.
  • Meets the criteria for ACA/AHA HF classification Stage A and B (Patient with clinical HF).

Exclusion Criteria

  • Exclusion criteria include patients with a diagnosis of dementia, patients on the heart transplant
  • list and stage IV HF.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Feasibility of Wearing a Readiband

Participants will wear the Fatigue Science Readiband for 42 consecutive day. On day one, every seventh day and at the end of the study each participant will complete the Dyspnea-Characteristic scale, BRICS NINR PROMIS Fatigue Short Form6a scale , Modified Pulmonary Functional Status, Dyspnea Questionnaire and the BRICS NINR PROMIS SF v1.0-Sleep Disturbance 6a scale.The Minnesota Living with Heart Failure Questionnaire and Self-Care of Heart Failure Index will be completed on day one and day 60. The purpose of this intervention is to assess the Feasibility of Wearing a Readiband.

Semi-structured Interview will be conducted at the end of 42 days to assess patient comfort and challenges with wearing the Readiband.
Device: Feasibility of wearing a Readiband to monitor Sleep and Fatigue
On day one of the study participants will complete a demographic survey. On day one, every seventh day and at the end of the study each participant will complete all the scales; The Minnesota Living with Heart Failure Questionnaire (MLHFQ) and Self-Care of Heart Failure Index will be completed on day one and day 60. At the end of the intervention an Interview will be conducted to assess participants experiences using the Readiband: On a scale of 0-10, how would you rate your digital literacy? 2) Why that number? 3) Tell me about a day using the readiband? 4) Were there any challenges to wearing the band, forgetting to wear it, level of comfort wearing the band? Anything else etc..? 5) How did the digital tools enhance your health? 6) Did the use of digital tools cause you to take a proactive approach rather than a reactive approach to your health? 7) As I use the readiband in a next study, what suggestions do you have for me?

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measure if the Readiband is able to measure Sleep and Fatigue
Time Frame: 42 days

Specific Aim #1: To evaluate the ability of HF patients to continuously wear a wrist-worn device (Readiband) for up to 42 days to monitor fatigue, activity and sleep.

These data will be gathered via the Readiband which is a wrist-worn device. It is not an instrument or a scale. The wrist-worn wearable device, Readiband (Fatigue Science) has a 93% accuracy rate in measuring sleep The Readiband and the biomathematical fatigue model SAFTE (Sleep, Activity, Fatigue, and Task Effectiveness) have being successfully used to measure sleep and fatigue in multiple areas of research.
42 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlation between data from the Readiband and the PROMIS scales
Time Frame: 42 days
Specific Aim #2: To determine if HF patients can use and interpret the data obtained from a wrist-worn device on their level of fatigue, activity, sleep, and other symptoms to self-manage symptoms. This aim will be addressed via descriptive statistics that will present items completed by study participants that reflect the use and ability of study participants to interpret data the data obtained from a wrist-worn device on their level of fatigue and sleep(BRICS NINR PROMIS Fatigue Short Form6a scale and the BRICS NINR PROMIS SF v1.0-Sleep Disturbance 6a scale) Readiband will be worn for 42 days and data will be generated on a daily basis.
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Amherst

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heather M Hamilton, PhD, RN, University of Massachusetts, Amherst

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-5684

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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