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Monitoring and Self-management of Sleep Fatigue and Dyspnea

NCT04434716 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-06-17

No results posted yet for this study

Summary

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.

Conditions

  • Heart Failure Patients

Interventions

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?

Sponsors & Collaborators

  • University of Massachusetts, Amherst

    lead OTHER

Principal Investigators

  • Heather M Hamilton, PhD, RN · University of Massachusetts, Amherst

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04434716 on ClinicalTrials.gov