Intervention for medication management in kidney transplant recipients

Development and pilot feasibility testing of an intervention to support immunosuppression medication adherence in kidney transplant recipients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14528733

Enrollment

Registered

2024-05-13

Start date

2024-08-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplant recipients Urological and Genital Diseases

Interventions

All participants will be allocated to the intervention arm. They will be sent the self-directed intervention booklet to work through in their own time. The psychoeducational manual aims to support kid

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Phase 1 inclusion criteria: 1. 18 years of age or over 2. Living with kidney disease 3. Speak and understand English Phase 2 patient participant inclusion criteria: 1. 18 years of age or over 2. Living with a kidney transplant 3. Prescribed immunosuppression medication. 4. Read and speak English 5. Evidence of sub-optimal immunosuppression medication adherence,i.e. a score of =23 on the Medication Adherence Rating Scale (MARS-5) Phase 2 healthcare professional participant inclusion criteria: 1. The healthcare professional is a consultant nephrologist, specialist renal transplant nurse, renal pharmacist or renal psychologist working in Guy’s Kidney Clinic.

Exclusion criteria

Exclusion criteria: Phase 1 exclusion criteria: 1. Currently under the care of a psychiatrist for a mental health condition 2. Insufficient command of English Phase 2 patient participant exclusion criteria: 1. Currently under the care of a psychiatrist for a mental health condition 2. Evidence of optimal immunosuppression medication adherence on the Medication Adherence Rating Scale (MARS-5), i.e. a total score of 24 or 25 3. Insufficient command of English

Design outcomes

Primary

Measure	Time frame
Feasibility will be assessed by collecting descriptive data on eligibility, recruitment and retention rates. The following will be determined: 1. Eligibility rate, recorded as the percentage of patients screened who meet the inclusion criteria 2. Uptake, recorded as the percentage of eligible patients agreeing to participate in the study by the end of recruitment 3. Retention, recorded as the percentage of participants who remain until the end of the study (i.e. complete the post-intervention questionnaire)	—

Measure

Time frame

Feasibility will be assessed by collecting descriptive data on eligibility, recruitment and retention rates. The following will be determined: 1. Eligibility rate, recorded as the percentage of patients screened who meet the inclusion criteria 2. Uptake, recorded as the percentage of eligible patients agreeing to participate in the study by the end of recruitment 3. Retention, recorded as the percentage of participants who remain until the end of the study (i.e. complete the post-intervention questionnaire)

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Secondary

Measure	Time frame
Measured at baseline and 6 weeks post-intervention: 1. Medication adherence measured using the Medication Adherence Report Scale (MARS-5): overall scores as well as intentional and unintentional non-adherence sub-scale scores 2. Transplant perceptions measured using the Brief Illness Perception Questionnaire (BIPQ) 3. Medication beliefs measured using the Beliefs about Medicines Questionnaire-Specific (BMQ-Specific): necessity and concern sub-scale scores, as well as a necessity-concerns differential. 4. Psychological distress measured using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) 5. Symptom occurrence and distress measured using the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59 (MTSOSD-59) 6. Self-efficacy surrounding symptom management and medication taking measured using the Theory of Planned Behaviour 7. Satisfaction with information about treatment measured using Satisfaction with Information about Medicines Scale (SIMS) 8. Quality of life measured using EQ-5D-3L	—

Measure

Time frame

Measured at baseline and 6 weeks post-intervention: 1. Medication adherence measured using the Medication Adherence Report Scale (MARS-5): overall scores as well as intentional and unintentional non-adherence sub-scale scores 2. Transplant perceptions measured using the Brief Illness Perception Questionnaire (BIPQ) 3. Medication beliefs measured using the Beliefs about Medicines Questionnaire-Specific (BMQ-Specific): necessity and concern sub-scale scores, as well as a necessity-concerns differential. 4. Psychological distress measured using the Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) 5. Symptom occurrence and distress measured using the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59 (MTSOSD-59) 6. Self-efficacy surrounding symptom management and medication taking measured using the Theory of Planned Behaviour 7. Satisfaction with information about treatment measured using Satisfaction with Information about Medicines Scale (SIMS) 8. Quality of life measured using EQ-5D-3L

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026