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ASK: Improving access to kidney transplantation

The ASK trial: a two-arm, parallel group, pragmatic individually-randomised controlled feasibility trial of a complex multicomponent intervention to improve AccesS to Kidney transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10989132
Enrollment
60
Registered
2020-11-06
Start date
2021-10-18
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Improving access to living-donor kidney transplantation for people with advanced kidney disease Urological and Genital Diseases Renal disease

Interventions

Intervention arm participants receive: • Clinician letter to potential donors regarding transplant need and option of living kidney donation plus simple-language living kidney donation information she

Sponsors

University of Bristol
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. English-speaking adults (age =18 years) 2. Individuals active on the UK Kidney Transplant only waiting list 3. Individuals who do not have any potential living kidney donors currently undergoing surgical assessment for donation

Exclusion criteria

Exclusion criteria: Individuals who lack the Mental Capacity (as determined by their healthcare team) to consent to participation.

Design outcomes

Primary

MeasureTime frame
1. Recruitment: % of those eligible and approached who consent to randomisation at invitation 2. Retention: % completing follow up questionnaire approximately 4 weeks after baseline visit questionnaire

Secondary

MeasureTime frame
1. Size of the eligible population – at screening 2. Adherence to intervention/trial and fidelity of delivery of the intervention - % of participants in intervention arm who receive both intervention components; number of letters sent to potential donors per participant in intervention arm; % of participants who complete questionnaires at baseline and approximately 4 weeks after baseline; number of protocol deviations reported; observed fidelity of intervention delivery (fidelity of delivery of the first meeting part of the intervention will be assessed using implementer self-report against a structured checklist and qualitative interviews with participants and implementers. Fidelity of the home visits will be assessed through structured observations with a quantitative checklist, qualitative observation notes, and participant and implementer qualitative interviews) 3. Acceptability of intervention and trial methods assessed through qualitative interviews 4. Barriers and facilitators to intervention implementation in different settings – measured by time to green light at each site and time to recruitment of first participant, and delivery of each intervention component 5. Estimates of the effect of the intervention on possible mediators of the intervention – measured through questionnaires measuring patient activation, social support, living-donor kidney transplant knowledge and health literacy at baseline and approximately 4 weeks later 6. Assessing data quality of linkage to UKRR data regarding planned outcome for later main trial (at 3 months follow-up data on the later RCT outcome [receipt of living-donor kidney transplant] will also be extracted from UKRR data and compared with data extracted from hospital records at site) 7. Impact on existing healthcare delivery measured through qualitative interviews with healthcare professionals after 3-months of study being active at study site 8. Cost-drivers measured at feasibility trial completion (major cost-drivers w

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 10, 2026