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CompletedNCT03977051Updated Apr 12, 2024Results posted

Exploring Immunosuppressant Medication Adherence in Kidney Transplant Patients

An observational study in Adherence, Medication and Transplantation, Kidney, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by Imperial College London · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
26
Ages
18 Years to 80 Years
Sex
All
01

Study summary

To describe the beliefs, understanding and experience of immunosuppressant medication adherence in our current transplant patient population through a series of patient focus groups

Read the 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.

02

Conditions studied

  • Adherence, Medication
  • Transplantation, Kidney

Keywords

  • Kidney transplantation
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In context

Lead sponsor

Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Kidney transplant patients

Inclusion criteria

  • Kidney transplant recipients transplanted and under the active follow up of ICRTC.
  • Speak and understand English
  • 18 years and above

Exclusion criteria

Exclusion Criteria:

  • Unable to speak and understand English
  • Below 18 years
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
26 participants (actual)
Patient registry
No

Groups and cohorts

  • Focus group

    Focus group to explore immunosuppressant medication adherence in kidney transplant patients

    Behavioral: Focus group

Interventions

  • BehavioralFocus group

    Kidneys transplant patients will discuss their attitudes and beliefs towards immunosuppressant medication adherence

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What researchers measure

Primary outcomes

  1. Number of Kidney Transplant Patients Who Expressed an Understanding of the Term Immunosuppression Medication Adherence and the Importance Immunosuppression Medication Adherence Post Transplant

    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

    Time frame: 4 months

  2. Number of Kidney Transplant Patients Who Identified Interventions to Support Immunosuppressant Medication Adherence

    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

    Time frame: 4 months

  3. Number of Patients Who Identify Barriers to Immunosuppression Medication Adherence

    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

    Time frame: 4 months

07

Results

Posted Apr 12, 2024

Participant flow

Participant flow — Overall Study
MilestoneFocus Group
Started26
Completed26
Not completed0

Outcome measures

PrimaryNumber of Kidney Transplant Patients Who Expressed an Understanding of the Term Immunosuppression Medication Adherence and the Importance Immunosuppression Medication Adherence Post Transplant

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

Time frame:
4 months
Reported as:
Count of participants · Participants
Number of Kidney Transplant Patients Who Expressed an Understanding of the Term Immunosuppression Medication Adherence and the Importance Immunosuppression Medication Adherence Post Transplant
ParticipantsFocus Group
Good understaning of the term19
Good understanding risk of rejection / graft loss19
PrimaryNumber of Kidney Transplant Patients Who Identified Interventions to Support Immunosuppressant Medication Adherence

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

Time frame:
4 months
Reported as:
Count of participants · Participants
Number of Kidney Transplant Patients Who Identified Interventions to Support Immunosuppressant Medication Adherence
ParticipantsFocus Group
Medicines compliance aids, smart-phone apps14
Support provided to them by the MDT26
Use of alarms and apps15
PrimaryNumber of Patients Who Identify Barriers to Immunosuppression Medication Adherence

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

Time frame:
4 months
Reported as:
Count of participants · Participants
Number of Patients Who Identify Barriers to Immunosuppression Medication Adherence
ParticipantsFocus Group
Forgetfulness / recall6
Ability to take at regular time / on emtpy stomach6
Adverse effects1

Adverse events

Collected over 4 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Focus Group0/26 (0%)0/26 (0%)0/26 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Focus Group
Mean56.19 (26.53 to 72.33)
Sex: Female, Male
Sex: Female, Male(Participants)Focus Group
Female15
Male11
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Focus Group
American Indian or Alaska Native0
Asian5
Native Hawaiian or Other Pacific Islander0
Black or African American0
White15
More than one race4
Unknown or Not Reported2
Region of Enrollment
Region of Enrollment(participants)Focus Group
United Kingdom26
Years since transplant
Years since transplant(years)Focus Group
Mean4.35 (0.19 to 13.99)
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Study locations

1 site
  • Imperial College Renal and Transplant Centre
    London, W12 0HS, United Kingdom
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References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 23, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — IPD will not be shared

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03977051
Lead sponsor
Imperial College London
Responsible party
Sponsor
First posted
Jun 6, 2019
Start date
Feb 8, 2017
Primary completion
Jun 20, 2017
Completion
Jun 20, 2017
Results posted
Apr 12, 2024
Last update
Apr 12, 2024

Study contacts

Dawn Goodall, MSC, BSc
principal investigator · Imperial College Healthcare NHS Trust

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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