Live Donors, Ethnic Minorities, TransplantationDiGiTNCT04327167
Digital Intervention for Ethnic Groups in Transplantation (DIGIT)
A study testing Video and questionnaire in people with Live Donors, Ethnic Minorities, Transplantation, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Live Donors, Ethnic Minorities, Transplantation
- What is being tested?
- Video and questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Sep 2019to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Anyone less than 18 years of age
- Unable to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Shafi Malik
Coventry, West Midlands
Shafi Malik, 024 7696 4000, shafi.malik1@nhs.net
About this study
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)
- 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.
- Study the long term psychological impact of BAME donors following donation.
- Being tested
- Video and questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video and questionnaireBehavioural
Also called Digital intervention
Potential donors would be shown a video and asked to complete a questionnaire to capture change in attitude towards donation.
| Study group | Role | What they receive |
|---|---|---|
| Digital intervention | Other | Not described Receives: Behavioral: Video and questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start23 Sep 2019
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Live Donors, Ethnic Minorities, TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327167
- Sponsor's protocol ID
- IRAS 250798
- Acronym
- DiGiT
- Status last verified
- Mar 2020
- First submitted
- 3 Dec 2019
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brand S, Daga S, Mistry K, Morsy M, Bagul A, Hamer R, Malik S. Sikh and Muslim perspectives on kidney transplantation: phase 1 of the DiGiT project - a qualitative descriptive study. BMJ Open. 2023 Dec 1;13(12):e059668. doi: 10.1136/bmjopen-2021-059668.
PubMed 38040423
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Intervention for Ethnic Groups in Transplantation (DIGIT)
- ClinicalTrials.gov ID
- NCT04327167
- Acronym / sponsor ID
- DiGiT / IRAS 250798
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- 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.
- Study the long term psychological impact of BAME donors following donation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital intervention | Other | Behavioral: Video and questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Anyone less than 18 years of age
- Unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video and questionnaireAlso: Digital interventionPotential donors would be shown a video and asked to complete a questionnaire to capture change in attitude towards donation. | Behavioural | Digital intervention |
Primary outcome
Magnitude of the change in score assessing knowledge of LDKT by study questionnaire
Time frame: 2 years
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
1 secondary outcome
Magnitude of change in QOL score pre donation to 1 year post donation
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Derived from this study: PubMed 38040423Brand S, Daga S, Mistry K, Morsy M, Bagul A, Hamer R, Malik S. Sikh and Muslim perspectives on kidney transplantation: phase 1 of the DiGiT project - a qualitative descriptive study. BMJ Open. 2023 Dec 1;13(12):e059668. doi: 10.1136/bmjopen-2021-059668.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video and questionnaire in people with Live Donors, Ethnic Minorities, Transplantation, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of the change in score assessing knowledge of LDKT by study questionnaire (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04327167, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.