Haemodialysis Outcomes & Patient Empowerment Study 02 (HOPE-02)

Pilot-scale, single-arm,observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients compared with bioimpedance and haemodialysis machine data.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; Dialysis; Complications; Volume Overload
• Intervention / Treatment: Device: Sixty device

Detailed Description

Pilot-scale, single-arm,observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients compared with bioimpedance and haemodialysis machine data.

The Sixty device uses diffuse reflectance spectroscopy to measure fluid status.

20 patients will be assessed during the study observation period.

10 patients undergo an observation period of approximately three weeks. The patients will be asked to wear the Sixty device during dialysis and at night throughout the study observation period.

Following the completion of this 3 week observation period, an additional 10 patients will wear the Sixty device as per the protocol for 3 weeks.

Haemodialysis parameters will be assessed as usual during the study.

Bioimpedance measurements will be taken pre and post-dialysis once weekly during the mid-week dialysis session:

Patient-reported symptoms related to haemodialysis will be recorded, including symptoms of hypervolaemia and hypovolaemia.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Ireland
  • Leinster
    • Dublin, Leinster, Ireland, 9
      • Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Require maintenance haemodialysis in an ambulatory care setting. Study will be conducted in a single centre in a tertiary hospital. Patients with a range of baseline fluid statuses will be considered for enrollment.

Description

Inclusion Criteria:

• On haemodialysis in an ambulatory care setting.
• Demonstrates understanding of correct use of the Sixty device.
• Capable and willing to measure blood pressure at home on a daily basis.
• Willing to give written informed consent.

Exclusion Criteria:

• Conditions precluding use of bioimpedance (e.g. Implantable Cardioverter Defibrillator, pacemakers, hearing aids, pregnancy).
• Significant confusion or any concomitant medical condition, which would limit the ability of the patient to record symptoms or other parameters.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational group; Observational group of 10 haemodialysis patients following usual care for 3 weeks.	Device: Sixty device; Prototype wearable hydration monitor to be worn by patient during dialysis and at night

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Sixty device versus bioimpedance	The primary endpoint will be to evaluate the accuracy of the Sixty device data in assessing volume in haemodialysis patients compared to bioimpedance Bioimpedance measurements will be performed using the Fresenius Body Composition Monitor (BCM)	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of changes in volume status as determined by Sixty device versus fluid removed per unit of time during haemodialysis session	Fluid removed (mls/ unit of time)	3 weeks
Comparison of changes in volume status as determined by Sixty device versus blood pressure	Blood pressure (mmHg)	3 weeks
Comparison of changes in volume status as determined by Sixty device versus change in weight pre and post dialysis	Weight (kg)	3 weeks
Comparison of changes in volume status as determined by Sixty device versus change in blood volume monitoring	Blood volume monitoring: Relative blood volume (%)	3 weeks
Acceptability of Sixty device	The patient's opinion of the acceptability of the Sixty device as assessed by their response to a questionnaire.	3 weeks

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland
• Collaborators: patientMpower Ltd.; Enterprise Ireland; Beaumont Hospital; Design to Value Ltd
• Investigators: Principal Investigator: Renal Dialysis Centre, Beaumont Hospital, RCSI

Publications and helpful links

General Publications

• Sandys V, Edwards C, McAleese P, O'Hare E, O'Seaghdha C. Protocol of a pilot-scale, single-arm, observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients. Pilot Feasibility Stud. 2022 Jan 24;8(1):17. doi: 10.1186/s40814-022-00976-7.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2021
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 2, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Dialysis; Sensor; Bioimpedance; Volume Overload
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: HOPE-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No