NCT03835364

Brief Summary

Co-design of a home-based anaemia monitoring system with participants who have previous diagnosis of anaemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

2.8 years

First QC Date

December 27, 2018

Last Update Submit

February 8, 2021

Conditions

AnemiaIron Deficiency Anemia

Outcome Measures

Primary Outcomes (2)

  • Qualitative capture of user feedback- Questionnaires

    User feedback gathered from participants using the anaemia monitoring device in participants' homes will be used to inform the changes necessary to develop a successful home-based anaemia monitoring system.

    14 months

  • Qualitative capture of user feedback- focus groups

    User feedback gathered from participants using the anaemia monitoring device in participants' homes will be used to inform the changes necessary to develop a successful home-based anaemia monitoring system.

    14 months

Interventions

Blood measurementDEVICE

Single fingerprick to measure haemoglobin and haematocrit measurements using the Aptus Home, anaemia home monitoring system.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Anyone over 18 years of age with a prior diagnosis of anaemia, who have the capability to sign consent for the themselves and commit to the requirements of the study.

You may qualify if:

  • Prior diagnosis of anaemia
  • Commitment to perform finger pricking to use the device every two weeks and complete 2 monthly questionnaires
  • Participant's willingness to participate in 1 to 1 interviews and, or focus groups
  • Understands and has a good level of spoken and written English

You may not qualify if:

  • No prior diagnosis of anaemia
  • Not committed to perform two weekly finger pricks to use device and complete 2 monthly questionnaires
  • Unwilling to attend interviews and focus groups
  • Doesn't have a good level of written and spoken English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Entia Ltd, Room G11, Screenworks, Highbury Grove, Highbury and Islington

London, N5 2EF, United Kingdom

Location

MeSH Terms

Conditions

AnemiaAnemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesAnemia, HypochromicIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2018

First Posted

February 8, 2019

Study Start

April 13, 2018

Primary Completion

January 15, 2021

Study Completion

January 15, 2021

Last Updated

February 9, 2021

Record last verified: 2021-02

Locations

GB(1)