Trial Outcomes & Findings for Exploring Immunosuppressant Medication Adherence in Kidney Transplant Patients (NCT NCT03977051)

NCT ID: NCT03977051

Last Updated: 2024-04-12

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 26 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2024-04-12

Participant Flow

Participant milestones

Measure	Focus Group Focus group to explore immunosuppressant medication adherence in kidney transplant patients Focus group: Kidneys transplant patients will discuss their attitudes and beliefs towards immunosuppressant medication adherence
Overall Study STARTED	26
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exploring Immunosuppressant Medication Adherence in Kidney Transplant Patients

Baseline characteristics by cohort

Measure	Focus Group n=26 Participants Focus group to explore immunosuppressant medication adherence in kidney transplant patients Focus group: Kidneys transplant patients will discuss their attitudes and beliefs towards immunosuppressant medication adherence
Age, Continuous	56.19 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United Kingdom	26 participants n=5 Participants
Years since transplant	4.35 years n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Focus Group n=26 Participants Focus group to explore immunosuppressant medication adherence in kidney transplant patients Focus group: Kidneys transplant patients will discuss their attitudes and beliefs towards immunosuppressant medication adherence
Number of Kidney Transplant Patients Who Expressed an Understanding of the Term Immunosuppression Medication Adherence and the Importance Immunosuppression Medication Adherence Post Transplant Good understaning of the term	19 Participants
Number of Kidney Transplant Patients Who Expressed an Understanding of the Term Immunosuppression Medication Adherence and the Importance Immunosuppression Medication Adherence Post Transplant Good understanding risk of rejection / graft loss	19 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Focus Group n=26 Participants Focus group to explore immunosuppressant medication adherence in kidney transplant patients Focus group: Kidneys transplant patients will discuss their attitudes and beliefs towards immunosuppressant medication adherence
Number of Kidney Transplant Patients Who Identified Interventions to Support Immunosuppressant Medication Adherence Medicines compliance aids, smart-phone apps	14 Participants
Number of Kidney Transplant Patients Who Identified Interventions to Support Immunosuppressant Medication Adherence Support provided to them by the MDT	26 Participants
Number of Kidney Transplant Patients Who Identified Interventions to Support Immunosuppressant Medication Adherence Use of alarms and apps	15 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Focus Group n=26 Participants Focus group to explore immunosuppressant medication adherence in kidney transplant patients Focus group: Kidneys transplant patients will discuss their attitudes and beliefs towards immunosuppressant medication adherence
Number of Patients Who Identify Barriers to Immunosuppression Medication Adherence Forgetfulness / recall	6 Participants
Number of Patients Who Identify Barriers to Immunosuppression Medication Adherence Ability to take at regular time / on emtpy stomach	6 Participants
Number of Patients Who Identify Barriers to Immunosuppression Medication Adherence Adverse effects	1 Participants

Adverse Events

Focus Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dawn Goodall

Imperial College London

Phone: +44 (0) 203 313 4268

Email: dawn.goodall1@nhs.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place