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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Imperial College Renal and Transplant Centre

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Focus group
Focus group to explore immunosuppressant medication adherence in kidney transplant patients
Behavioral: Focus group
Kidneys transplant patients will discuss their attitudes and beliefs towards immunosuppressant medication adherence

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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