Self Testing Own Kidneys (STOK) Study

A study to evaluate feasibility, safety and impact of patients self-testing their own kidney function at home

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68116915

Enrollment

Registered

2019-01-14

Start date

2018-11-28

Completion date

Unknown

Last updated

2023-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Renal Disorders, Primary sub-specialty: Renal Disorders

Interventions

The study design and methodology has been influenced and chosen following input by members of the Research Design Service. The trialists have also incorporated health economist and statistician review

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participant criteria - adequate cognitive and functional ability to enable competency-based training to use hand-held medical devices 2. Clinical criteria - adults who have previously received a kidney transplant and are clinically well with stable kidney transplant function, based upon assessment by their consultant nephrologist 3. Aged 18 years or older 4. Capacity to consent to take part in study

Exclusion criteria

Exclusion criteria: 1. Patients not meeting inclusion criteria 2. Pregnancy 3. Clinical instability or drug changes within previous 4 weeks 4. Participants currently taking part in another research study

Design outcomes

Primary

Measure	Time frame
The feasibility, safety and accuracy of patients self-testing their kidney function from capillary blood samples using ISTAT Alinity devices at home, when compared to blood samples obtained and tested by study nurses using both i-STAT Alinity devices and NHS laboratory analysis. This will be measured from baseline to the end of study at week 4.	—

Secondary

Measure	Time frame
1. Patient experience, acceptability and usability, assessed through diary, questionnaires and interview analysis from baseline until the end of study interviews 2. Economic viability of patient self-testing kidney function at home, assessed through analysis of questionnaires, interviews and care pathway analysis from baseline until the end of study interviews 3. Complications and adverse events: the nature and frequency of device-specific and non-device events collected by direct questioning of the patient on a weekly basis when they attend clinic and note review where necessary. This is from the baseline visit until week 4	—

Measure

Time frame

1. Patient experience, acceptability and usability, assessed through diary, questionnaires and interview analysis from baseline until the end of study interviews 2. Economic viability of patient self-testing kidney function at home, assessed through analysis of questionnaires, interviews and care pathway analysis from baseline until the end of study interviews 3. Complications and adverse events: the nature and frequency of device-specific and non-device events collected by direct questioning of the patient on a weekly basis when they attend clinic and note review where necessary. This is from the baseline visit until week 4

—

Countries

England, United Kingdom

Contacts

Public ContactJonathan Murray

jonathan.murray2@nhs.net+44 (0)1642 854731

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026