Project Aura: Home Trial of a Home-based Monitoring Service

NCT04137315 | Completed

• 1 other identifier: IRAS: 272300
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a data collection study to compare diagnostic methods of a prototype of a home monitoring device against laboratory testing in the hospital.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Quantitative capture of measurement system

  Data collection for evaluation of measurement system

  6 months

Interventions

Blood measurement DEVICE

Single fingerprick to measure haemoglobin and haematocrit measurements using a potential haemoglobin home monitoring system.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be recruited from the study site.

You may qualify if:

• Age ≥ 18 years of age.
• Adequate english to participate in training sessions and use the analyser.
• Patients of the study site who are currently undergoing treatment for anaemia of CKD with ESAs.
• Patients who are not pregnant.
• Patients who do not have a bleeding disorder.
• Patients willing to perform self-tests 2-3 times a week.
• Patients capable of providing informed consent before attending training.
• Patients or patients with a carer capable of fine manipulation of the device and its consumables.
• Patients or patients with a carer who own a smartphone which can download the app related to this study.
• Patients or patients with carers who do not have eyesight limitations to be able to read the instructions on the screen of the prototype device.
• Patients who are not expected to have to start dialysis treatment during the course of this study.

You may not qualify if:

• Does not have adequate English to participate in training or use the analyser without an interpreter.
• Patients of the study site who are not currently undergoing anaemia treatment with ESAs.
• Patients of the study site not willing to perform self-tests 2-3 times a week.
• Patients of the study site not capable of providing consent or have a suitable, legally acceptable representative present to provide consent before the trial.
• Patients who are pregnant.
• Patients with a bleeding disorder.
• Patients or their nominated carers who are not capable of fine manipulation of the device and its consumables.
• Neither patients or their nominated carers do not own a smartphone which can install the app related to this study.
• Patients or their nominated carers with eyesight limitations to not be able to read the instructions on the screen of the prototype device.
• Patients who are expected to start dialysis treatment during the study.

Sponsors & Collaborators

• Entia Ltd: lead

Study Sites (1)

Hull University Teaching Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sunil Bhandari, FHEA

  Hull University Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: February 14, 2020
• Primary Completion: January 29, 2021
• Study Completion: January 29, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)