- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03977051
Exploring Immunosuppressant Medication Adherence in Kidney Transplant Patients
October 25, 2023 updated by: Imperial College London
To describe the beliefs, understanding and experience of immunosuppressant medication adherence in our current transplant patient population through a series of patient focus groups
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators want to understand more about why some of our kidney transplant patients find it difficult to take their anti-rejection medicines as intended.
It is hoped that if the investigators can improve their understanding of why some patients struggle with their anti-rejection medicines, the investigators will be able to find better ways to help our transplant patients and so fewer patients may develop problems with their transplant.
This study will collect qualitative data from a series of focus groups with kidney transplant recipients to explore their beliefs, understanding and experience of anti-rejection medication adherence.
The focus groups will also explore the support that participants have received to help them with their medication adherence and what support they feel should be available to them and to others in the future to optimise anti-rejection medication adherence in transplant patients.
Five focus groups will be undertaken.
Each focus group will include six patients and will last for approximately 1.5 hours.
All participants will be kidney transplant recipients transplanted and followed up at Imperial College Renal and Transplant Centre.
Study Type
Observational
Enrollment (Actual)
26
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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London, United Kingdom, W12 0HS
- Imperial College Renal and Transplant Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Kidney transplant patients
Description
Inclusion Criteria:
- Kidney transplant recipients transplanted and under the active follow up of ICRTC.
- Speak and understand English
- 18 years and above
Exclusion Criteria:
- Unable to speak and understand English
- Below 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Focus group
Focus group to explore immunosuppressant medication adherence in kidney transplant patients
|
Kidneys transplant patients will discuss their attitudes and beliefs towards immunosuppressant medication adherence
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Kidney Transplant Patients Who Expressed an Understanding of the Term Immunosuppression Medication Adherence and the Importance Immunosuppression Medication Adherence Post Transplant
Time Frame: 4 months
|
Through a series of focus groups, the investigators will qualitatively explore kidney transplant patients' understanding of the terms immunosuppressant medication adherence and nonadherence.
What importance do patients attach to adherence.
Do patients understand that nonadherence may effect the outcome of the transplant.
The focus groups will identify the common practical and perceptual barriers to adherence identified by transplant patients and the interventions kidney transplant patients have used to try and improve their adherence.
The focus groups will identify which interventions patients have found effective and which interventions patients have not found to be effective to improve their adherence.
They will also identify support patients have had with adherence since their transplant, the support patients feel could have helped them to better adhere to their medicines up to now and the support our patients feel would help them to adhere better to their medicines in the future
|
4 months
|
Number of Kidney Transplant Patients Who Identified Interventions to Support Immunosuppressant Medication Adherence
Time Frame: 4 months
|
Through a series of focus groups, the investigators will qualitatively explore kidney transplant patients' understanding of the terms immunosuppressant medication adherence and nonadherence.
What importance do patients attach to adherence.
Do patients understand that nonadherence may effect the outcome of the transplant.
The focus groups will identify the common practical and perceptual barriers to adherence identified by transplant patients and the interventions kidney transplant patients have used to try and improve their adherence.
The focus groups will identify which interventions patients have found effective and which interventions patients have not found to be effective to improve their adherence.
They will also identify support patients have had with adherence since their transplant, the support patients feel could have helped them to better adhere to their medicines up to now and the support our patients feel would help them to adhere better to their medicines in the future
|
4 months
|
Number of Patients Who Identify Barriers to Immunosuppression Medication Adherence
Time Frame: 4 months
|
Through a series of focus groups, the investigators will qualitatively explore kidney transplant patients' understanding of the terms immunosuppressant medication adherence and nonadherence.
What importance do patients attach to adherence.
Do patients understand that nonadherence may effect the outcome of the transplant.
The focus groups will identify the common practical and perceptual barriers to adherence identified by transplant patients and the interventions kidney transplant patients have used to try and improve their adherence.
The focus groups will identify which interventions patients have found effective and which interventions patients have not found to be effective to improve their adherence.
They will also identify support patients have had with adherence since their transplant, the support patients feel could have helped them to better adhere to their medicines up to now and the support our patients feel would help them to adhere better to their medicines in the future
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dawn Goodall, MSC, BSc, Imperial College Healthcare NHS Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 8, 2017
Primary Completion (Actual)
June 20, 2017
Study Completion (Actual)
June 20, 2017
Study Registration Dates
First Submitted
April 25, 2017
First Submitted That Met QC Criteria
June 4, 2019
First Posted (Actual)
June 6, 2019
Study Record Updates
Last Update Posted (Actual)
April 12, 2024
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 16HH3697
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD will not be shared
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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