Digital Intervention for Ethnic Groups in Transplantation (DIGIT) (DiGiT)

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.

Study Overview

• Status: Unknown
• Conditions: Live Donors, Ethnic Minorities, Transplantation
• Intervention / Treatment: Behavioral: Video and questionnaire

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Midlands
    • Coventry, West Midlands, United Kingdom
      • Recruiting
      • Shafi Malik
      • Contact: Shafi Malik; Phone Number: 024 7696 4000; Email: shafi.malik1@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Digital 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.; Other Names: Digital intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Anticipated): November 30, 2020
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 27, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IRAS 250798

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No