Recruiting

Observational Study

Sponsor:

University of Massachusetts, Amherst

Code:

NCT04434716

Conditions

Heart Failure Patients

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Feasibility of wearing a Readiband to monitor Sleep and Fatigue

Study Details

Brief 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

Study ID

NCT04434716

Start date

Aug 15, 2019

Status verified date

Jun, 2020

Completion date

Apr 30, 2021

Anticipated

Primary completion date

Apr 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

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.

Interventions

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?

Primary outcome measure

  • Measure if the Readiband is able to measure Sleep and Fatigue [ Time Frame: 42 days ]

Central Contacts and Locations

Central contacts

Heather Hamilton, PhD RN

413-545-7174hamilton@umass.edu

Ian Cooke, PhD

4135455087icooke@umass.edu

Locations

University of Massachusetts Amherst

Recruiting

Amherst, Massachusetts, United States, 01003

Contacts

Heather Hamilton, PhD RN

413-545-7174hamilton@umass.edu

Principal Investigator:

Heather Hamilton, PhD RN

More Information

Sponsor

University of Massachusetts, Amherst

Last update posted

Jun 17, 2020

Last verified

Jun, 2020

Keywords

  • Heart failure
  • African Americans
  • Wrist worn device
  • Mixed- method

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Amherst on 2020-06-17.