Haemodialysis Outcomes & Patient Empowerment Study 02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-21

Study Completion Date

2021-06-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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End Stage Renal Disease Dialysis; Complications Volume Overload

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational group

Observational group of 10 haemodialysis patients following usual care for 3 weeks.

Sixty device

Intervention Type DEVICE

Prototype wearable hydration monitor to be worn by patient during dialysis and at night

Interventions

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Sixty device

Prototype wearable hydration monitor to be worn by patient during dialysis and at night

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No