HOPE-02: Haemodialysis Outcomes & Patient Empowerment Study 02
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Accuracy of Sixty device versus bioimpedance [3 weeks]
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)
Secondary Outcome Measures
- Comparison of changes in volume status as determined by Sixty device versus fluid removed per unit of time during haemodialysis session [3 weeks]
Fluid removed (mls/ unit of time)
- Comparison of changes in volume status as determined by Sixty device versus blood pressure [3 weeks]
Blood pressure (mmHg)
- Comparison of changes in volume status as determined by Sixty device versus change in weight pre and post dialysis [3 weeks]
Weight (kg)
- Comparison of changes in volume status as determined by Sixty device versus change in blood volume monitoring [3 weeks]
Blood volume monitoring: Relative blood volume (%)
- Acceptability of Sixty device [3 weeks]
The patient's opinion of the acceptability of the Sixty device as assessed by their response to a questionnaire.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
On haemodialysis in an ambulatory care setting.
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Demonstrates understanding of correct use of the Sixty device.
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Capable and willing to measure blood pressure at home on a daily basis.
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Willing to give written informed consent.
Exclusion Criteria:
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Conditions precluding use of bioimpedance (e.g. Implantable Cardioverter Defibrillator, pacemakers, hearing aids, pregnancy).
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Significant confusion or any concomitant medical condition, which would limit the ability of the patient to record symptoms or other parameters.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beaumont Hospital | Dublin | Leinster | Ireland | 9 |
Sponsors and Collaborators
- Royal College of Surgeons, Ireland
- Beaumont Hospital
- patientMpower Ltd.
- Design to Value Ltd
- Enterprise Ireland
Investigators
- Principal Investigator: Renal Dialysis Centre, Beaumont Hospital, RCSI
Study Documents (Full-Text)
More Information
Publications
None provided.- HOPE-02