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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04137315
Recruitment Status : Not yet recruiting
First Posted : October 24, 2019
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Entia Ltd

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.

Condition or disease Intervention/treatment
Chronic Kidney Diseases Device: Blood measurement

Detailed Description:

The device/monitoring system being developed measures the haemoglobin and haematocrit levels in blood from a single drop of blood. By measuring these blood parameters, participants are able to monitor their haemoglobin level at home.

The use of the device will take place in the participant's home to simulate what the investigators believe will be the ideal location for people who would prefer to self-manage their condition.

This study is a data collection study to evaluate the performance of the prototype.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Project Aura: Data Collection for a Home Monitoring Solution for Patients With Anaemia to Evaluate Delivery of Treatment
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Intervention Details:
  • Device: Blood measurement
    Single fingerprick to measure haemoglobin and haematocrit measurements using a potential haemoglobin home monitoring system.


Primary Outcome Measures :
  1. Quantitative capture of measurement system [ Time Frame: 6 months ]
    Data collection for evaluation of measurement system



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The participants will be recruited from the study site.
Criteria

Inclusion Criteria:

  • Age ≥ 16 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04137315


Contacts
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Contact: Madeline Lok, MEng 02030200030 madeline@entia.co

Locations
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United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom, HU3 2JZ
Sponsors and Collaborators
Entia Ltd
Investigators
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Principal Investigator: Sunil Bhandari, FHEA Hull University Teaching Hospitals NHS Trust

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Responsible Party: Entia Ltd
ClinicalTrials.gov Identifier: NCT04137315    
Other Study ID Numbers: IRAS: 272300
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study data will be pseudonymous (shared with the research & clinical team). Participant data is only seen by the research nurse for contacting, updating and travel reimbursement purposes.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency