Self Testing Own Kidneys (STOK) Study

Not Applicable

Completed

• Conditions: Specialty: Renal Disorders, Primary sub-specialty: Renal Disorders; Health Category: Renal and Urogenital; Disease/Condition: Other disorders of kidney and ureter; Urological and Genital Diseases

• Registration Number: ISRCTN68116915
• Lead Sponsor: South Tees Hospitals NHS Foundation Trust

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37284676/ (added 08/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-14
• Study Completion: 2020-10-15
• Last Update Posted: 20 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
<br> 1. Patient experience, acceptability and usability, assessed through diary, questionnaires and interview analysis from baseline until the end of study interviews<br> 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<br> 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<br>