Digital Intervention for Ethnic Groups in Transplantation (DIGIT)

Live Donors, Ethnic Minorities, Transplantation Clinical Trial

— DiGiT  

Official title:

Digital Intervention for Ethnic Groups in Transplantation (DIGIT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04327167
• Other study ID #: IRAS 250798
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2019
• Est. completion date: November 30, 2021

Study information

• Verified date: March 2020
• Source: University Hospitals Coventry and Warwickshire NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study Title Digital intervention for Ethnic Groups in Transplantation (DiGiT)

Internal ref. no. (or short title) DiGiT Study Design Observational cohort study Study Participants 90 Planned Size of Sample (if applicable) 30 Follow up duration (if applicable) 2 years Planned Study Period 2 years Research Question/Aim(s)

1. To produce, test and pilot a video-based intervention about living donor kidney transplantation in Black, Asian & Minority ethnic (BAME) community in United Kingdom. Embedded within this is an ambassador training.

2. Study the long term psychological impact of BAME donors following donation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults >18 years of age

• Belong to a BAME community only for phase 1-3, in phase 4 all past and future donors regardless of ethnicity would be eligible.

• Be a community member, past donor, past recipient of a transplant, healthcare professional or be on the waiting list for a transplant.

Exclusion Criteria:

• Anyone less than 18 years of age

• Unable to consent

Related Conditions & MeSH terms

• Live Donors, Ethnic Minorities, Transplantation

Intervention

Behavioral:
• Video and questionnaire
Potential donors would be shown a video and asked to complete a questionnaire to capture change in attitude towards donation.

Locations

Country	Name	City	State
United Kingdom	Shafi Malik	Coventry	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Coventry and Warwickshire NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnitude of the change in score assessing knowledge of LDKT by study questionnaire	Change in attitudes and knowledge of LDKT will be assessed by study questionnaire and the magnitude in change will be quantified by the change in score following digital intervention	2 years
Secondary	Magnitude of change in QOL score pre donation to 1 year post donation	Change in QOL as measured by SF 36 in the 3 months preceding donation and 1 year post donation.	2 years