Medication AdherenceNCT03892317
Improving Adherence in Nonadherent Kidney Transplant Patients
A study testing Pharmacist led medication adherence interventions in people with Medication Adherence and Kidney Transplantation, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Organs for transplantation remain a scarce and precious resource with over 5000 patients currently on the kidney transplant waiting list. A kidney transplant costs approximately £17,000 in the first year and £5,000 per subsequent year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Kidney Transplantation
- What is being tested?
- Pharmacist led medication adherence interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 May 2018to 27 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult kidney transplant patients (18 years of age and above)
- Kidney transplant patients with an IPV of tacrolimus levels of greater than 18.15% in the previous 12 months
Who cannot join
- Antibody incompatible transplants including patients with preformed HLA and blood group incompatible
- Previous rejection
- Donor specific antibody positive
- HIV positive patients
- Simultaneous pancreas and kidney patients
- Paediatric patients (less than 18 years of age)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Renal and Transplant Centre
London, W12 0HS
About this study
Official title: A Pharmacist Led, Patient Tailored Intervention to Improve Immunosuppressant Medication Adherence in Nonadherent Kidney Transplant Patients
Organs for transplantation remain a scarce and precious resource with over 5000 patients currently on the kidney transplant waiting list. A kidney transplant costs approximately £17,000 in the first year and £5,000 per subsequent year. If the transplant fails, the patient must return to dialysis at an estimated cost of £30,800 per year or be retransplanted. While short term outcomes have improved steadily over the last 15-20 years, longer term outcomes haven't and after 10 years approximately 30% of kidney transplants have failed. Nonadherence to immunosuppressive medication is increasingly being associated with these poor long term outcomes and studies have estimated that 30- 50% of transplant patients are nonadherent to their immunosuppressive medication. The investigators want to determine whether immunosuppression medication adherence can be improved in a group of patients receiving tailored medication adherence support form a pharmacist. Adherence support will be provided for one year and will be individualised to each patient in the intervention group after identifying both their practical and perceptual barriers to adherence. The adherence interventions offered may include additional education and medication counselling, setting alarms, provision of a medication list, the use of a medications adherence app on a smart phone, reducing the number and frequency of tablets a patient takes or referral on to another health professional such as a social worker or psychologist for additional support. A range of clinical outcomes will be assessed for all patients on a regular basis in order to determine whether the provision of effective medication adherence support for the kidney transplant patients may help to optimise the long-term outcomes of these transplants
Read the detailed description
This study will be undertaken using a prospective, multidimensional design. 42 nonadherent kidney transplant patients will be included in the intervention group. The nonadherent patients will be identified through Imperial College Renal and Transplant Centre (ICRTC) Outpatient Clinic based at Hammersmith Hospital. Standard and transplant specific demographics will be collected for all patients. All kidney transplant patients have their tacrolimus levels measured at each clinic visit. The variability of these levels can be used as a marker of their adherence. Patients with a high intrapatient variability (IPV) of their levels are said to be nonadherent. The Chief Investigator or another member of the research team will approach individual patients directly in the transplant out-patient clinic where they are members of the multidisciplinary clinical care team. The Chief Investigator or another member of the research team may also telephone patients to invite them to clinic to discuss participation in the trial. The Chief Investigator or another member of the research team will describe the study to the patient, answer any questions they have and provide them with a participant information sheet (PIS). Patients will be given the opportunity to take the PIS away and think about whether they would like to participate. A follow up discussion either in clinic or on the phone will be arranged with the patient to answer any queries they have within two weeks of providing them with the PIS; during that discussion, the Chief Investigator or other member of the research team will arrange an appointment in the transplant clinic with the patient to sign the consent form if they do decide to participate. Patients recruited into the study will receive pharmacist led, patient tailored interventions to improve immunosuppressant medication adherence. Patients will be included in the study for one year from recruitment.
The pharmacist led, patient tailored intervention will involve regular, intensive, personalised support from a pharmacist to improve adherence to immunosuppressive medications. The pharmacist will meet with the patient on a regular basis in the transplant clinic to identify their perceptual and practical barriers to adherence and agree a support plan that is tailored to them.
Within the first two weeks of recruitment, the study pharmacist will meet with the patient in transplant clinic to:
- Undertake a full medication history
- Discuss self-reported medication nonadherence
- Undertake the BAASIS questionnaire
- Ask the patient to complete a Beliefs about Medicines Questionnaire (BMQ)
- Undertake a socioeconomic and educational assessment
- Undertake to gain collateral reporting of nonadherence by clinicians, relatives, friends or carers
- Perform a tacrolimus pill count
- Check in-house dispensing records of tacrolimus
- Identify barriers to adherence
- Tailor interventions and support to the needs of the patient
- Complete a motivational interview
- Agree to meet again during an outpatient clinic visit within an agreed time which is appropriate for the patient needs and within 3 months.
This first visit will provide a baseline assessment of the patient's medication adherence.
Tailored support may include:
- Setting alarms
- Medication diary card or calendar
- Medication compliance aid filled by the patient, family/carers or by a pharmacy professional
- Adherence app
- Reducing the complexity of the medication regime
- Positioning medication within their daily routine eg. by toothbrush
- Changing formulations
- Additional education regarding need for medication / timing of doses
- Referral to a social worker to assist with affordability of medicines
- Referral to a psychologist to explore deeper psychological issues regarding medicines taking
The structure of each follow up adherence review will be the same as the first formal adherence review with the exception that the BMQ will only be repeated at the end of the one year follow-up and the socioeconomic and educational assessment will only be undertaken at the first assessment review. Every patient will have a formal adherence assessment at recruitment and then at 3, 6, 9 and 12 months. At the end of one year of follow-up, the specific benefits perceived by the patient of intensive adherence support from a pharmacist will be determined through a questionnaire.
Baseline nonadherence will be measured at the first visit with the study pharmacist within two weeks of recruitment and then at 3, 6, 9 and 12 months. The IPV of their tacrolimus levels and their outpatient clinic nonattendance rate will be measured retrospectively in the 12 months prior to recruitment to the study and then prospectively at the end of the intervention year. The IPV is calculated from the tacrolimus levels measured for an individual patient using the coefficient of variance mathematical formula - Coefficient of variance (COV) defined as: SD x 100 / Mean. The outpatient clinic nonattendance for each participant will be taken from the hospital integrated computer system.
- Conditions
- Medication Adherence, Kidney Transplantation
- Being tested
- Pharmacist led medication adherence interventions
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist led medication adherence interventionsBehavioural
Medication adherence interventions which will be tailored to individual patient need
| Study group | Role | What they receive |
|---|---|---|
| Medication adherence interventions | Other | Pharmacist led medication adherence interventions which will be tailored to individual patient need Receives: Behavioral: Pharmacist led medication adherence interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Patients Being Adherent/Non-aherent After the Intervention
Immunosuppression Medication adherence will be assessed and compared using the BAASIS questionnaire at recruitment and at the end of the study. The BAASIS questionnaire is a closed question questionnaire (either adherent or non-adherent); it is validated for assessing immunosuppression nonadherence in transplant patients. Any patient answering yes to any of the questions is assessed to be nonadherent
Measured: One year
Change in the Median IPV Before and After the Intervention
Intrapatient variability of tacrolimus levels will be measured and compared and reported as percentage difference
Measured: One year
Change in Outpatient Clinic Nonattendance Rate Before and After the Intervention
Data for this outcome measure has not been analysed: originally the outpatient clinic nonattendance rate was to be assessed and compared during the 12 months prior to recruitment to the study and during the study
Measured: One year
Secondary outcomes (12)
Biopsy Proven ACR / AMR
Number of patients who develop biopsy proven ACR/AMR
Measured: One year
The Number of Readmissions
The number of readmissions and their reasons why during the study will be recorded
Measured: One year
Donor Specific Antibody (DSA) or Transplant Glomerulopathy
For secondary outcome measures 6\&7 - no one developed a Donor Specific Antibody (DSA) or Transplant Glomerulopathy, Fibrosis, Hyalinosis, Calcineurin Inhibitor (CNI) Toxicity or Diabetic Change.
Number of patients who develop a DSA or transplant glomerulopathy (CNI) toxicity or diabetic change on biopsy
Measured: One year
Fibrosis, Hyalinosis, Calcineurin Inhibitor (CNI) Toxicity or Diabetic Change on Toxicity
For secondary outcome measures 6\&7 - No biopsies were indicated throughout the study therefore no one developed Fibrosis, Hyalinosis, Calcineurin Inhibitor (CNI) Toxicity or Diabetic Change
Number of patients who develop fibrosis, hyalinosis, calcineurin inhibitor
Measured: One year
Graft Loss
Number of patients who lose their graft
Measured: One year
Death
Number of patients who die
Measured: One year
Serum Creatinine
Change in serum creatinine at the end of the study Data for this outcome measure has not been analysed
Measured: One year
eGFR
Change in eGFR at the end of the study. Data for this outcome measure has not been analysed
Measured: One year
Proteinuria
Change in proteinuria at the end of the study. Data for this outcome measure has not been analysed
Measured: One year
Haematocrit
Change in haematocrit at the end of the study. Data for this outcome measure has not been analysed
Measured: One year
Haemoglobin
Change in haemoglobin at the end of the study. Data for this outcome measure has not been analysed
Measured: One year
Albumin
Change in albumin at the end of the study. Data for this outcome measure has not been analysed
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start14 May 2018
- Primary completion27 Jul 2020
- Study completion27 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dawn Goodall, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892317
- Sponsor's protocol ID
- 17HH4287
- Status last verified
- Oct 2024
- First submitted
- 5 Oct 2018
- Last updated
- 5 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Bleser L, Matteson M, Dobbels F, Russell C, De Geest S. Interventions to improve medication-adherence after transplantation: a systematic review. Transpl Int. 2009 Aug;22(8):780-97. doi: 10.1111/j.1432-2277.2009.00881.x. Epub 2009 Apr 6.
PubMed 19386076Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009 Nov;9 Suppl 3:S1-155. doi: 10.1111/j.1600-6143.2009.02834.x.
PubMed 19845597Denhaerynck K, Steiger J, Bock A, Schafer-Keller P, Kofer S, Thannberger N, De Geest S. Prevalence and risk factors of non-adherence with immunosuppressive medication in kidney transplant patients. Am J Transplant. 2007 Jan;7(1):108-16. doi: 10.1111/j.1600-6143.2006.01611.x. Epub 2006 Nov 15.
PubMed 17109727Fine RN, Becker Y, De Geest S, Eisen H, Ettenger R, Evans R, Rudow DL, McKay D, Neu A, Nevins T, Reyes J, Wray J, Dobbels F. Nonadherence consensus conference summary report. Am J Transplant. 2009 Jan;9(1):35-41. doi: 10.1111/j.1600-6143.2008.02495.x.
PubMed 19133930Gaston RS, Hudson SL, Ward M, Jones P, Macon R. Late renal allograft loss: noncompliance masquerading as chronic rejection. Transplant Proc. 1999 Jun;31(4A):21S-23S. doi: 10.1016/s0041-1345(99)00118-9. No abstract available.
PubMed 10372038Morrissey PE, Flynn ML, Lin S. Medication noncompliance and its implications in transplant recipients. Drugs. 2007;67(10):1463-81. doi: 10.2165/00003495-200767100-00007.
PubMed 17600393Morrissey PE, Reinert S, Yango A, Gautam A, Monaco A, Gohh R. Factors contributing to acute rejection in renal transplantation: the role of noncompliance. Transplant Proc. 2005 Jun;37(5):2044-7. doi: 10.1016/j.transproceed.2005.03.017.
PubMed 15964334Prendergast MB, Gaston RS. Optimizing medication adherence: an ongoing opportunity to improve outcomes after kidney transplantation. Clin J Am Soc Nephrol. 2010 Jul;5(7):1305-11. doi: 10.2215/CJN.07241009. Epub 2010 May 6.
PubMed 20448067Schafer-Keller P, Steiger J, Bock A, Denhaerynck K, De Geest S. Diagnostic accuracy of measurement methods to assess non-adherence to immunosuppressive drugs in kidney transplant recipients. Am J Transplant. 2008 Mar;8(3):616-26. doi: 10.1111/j.1600-6143.2007.02127.x.
PubMed 18294158Wiebe C, Nevins TE, Robiner WN, Thomas W, Matas AJ, Nickerson PW. The Synergistic Effect of Class II HLA Epitope-Mismatch and Nonadherence on Acute Rejection and Graft Survival. Am J Transplant. 2015 Aug;15(8):2197-202. doi: 10.1111/ajt.13341. Epub 2015 Jun 11.
PubMed 26095765Sellares J, de Freitas DG, Mengel M, Reeve J, Einecke G, Sis B, Hidalgo LG, Famulski K, Matas A, Halloran PF. Understanding the causes of kidney transplant failure: the dominant role of antibody-mediated rejection and nonadherence. Am J Transplant. 2012 Feb;12(2):388-99. doi: 10.1111/j.1600-6143.2011.03840.x. Epub 2011 Nov 14.
PubMed 22081892Roberts DM, Jiang SH, Chadban SJ. The treatment of acute antibody-mediated rejection in kidney transplant recipients-a systematic review. Transplantation. 2012 Oct 27;94(8):775-83. doi: 10.1097/TP.0b013e31825d1587.
PubMed 23032865Wiebe C, Gibson IW, Blydt-Hansen TD, Karpinski M, Ho J, Storsley LJ, Goldberg A, Birk PE, Rush DN, Nickerson PW. Evolution and clinical pathologic correlations of de novo donor-specific HLA antibody post kidney transplant. Am J Transplant. 2012 May;12(5):1157-67. doi: 10.1111/j.1600-6143.2012.04013.x. Epub 2012 Mar 19.
PubMed 22429309Pinsky BW, Takemoto SK, Lentine KL, Burroughs TE, Schnitzler MA, Salvalaggio PR. Transplant outcomes and economic costs associated with patient noncompliance to immunosuppression. Am J Transplant. 2009 Nov;9(11):2597-606. doi: 10.1111/j.1600-6143.2009.02798.x.
PubMed 19843035Butler JA, Roderick P, Mullee M, Mason JC, Peveler RC. Frequency and impact of nonadherence to immunosuppressants after renal transplantation: a systematic review. Transplantation. 2004 Mar 15;77(5):769-76. doi: 10.1097/01.tp.0000110408.83054.88.
PubMed 15021846
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacist Led, Patient Tailored Intervention to Improve Immunosuppressant Medication Adherence in Nonadherent Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT03892317
- Acronym / sponsor ID
- 17HH4287
- Conditions
- Medication Adherence, Kidney Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- 27 Jul 2020 (actual)
- Study completion
- 27 Jul 2020 (actual)
- First posted
- 27 Mar 2019 (actual)
- Results
- Posted 5 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Organs for transplantation remain a scarce and precious resource with over 5000 patients currently on the kidney transplant waiting list. A kidney transplant costs approximately £17,000 in the first year and £5,000 per subsequent year. If the transplant fails, the patient must return to dialysis at an estimated cost of £30,800 per year or be retransplanted. While short term outcomes have improved steadily over the last 15-20 years, longer term outcomes haven't and after 10 years approximately 30% of kidney transplants have failed. Nonadherence to immunosuppressive medication is increasingly being associated with these poor long term outcomes and studies have estimated that 30- 50% of transplant patients are nonadherent to their immunosuppressive medication. The investigators want to determine whether immunosuppression medication adherence can be improved in a group of patients receiving tailored medication adherence support form a pharmacist. Adherence support will be provided for one year and will be individualised to each patient in the intervention group after identifying both their practical and perceptual barriers to adherence. The adherence interventions offered may include additional education and medication counselling, setting alarms, provision of a medication list, the use of a medications adherence app on a smart phone, reducing the number and frequency of tablets a patient takes or referral on to another health professional such as a social worker or psychologist for additional support. A range of clinical outcomes will be assessed for all patients on a regular basis in order to determine whether the provision of effective medication adherence support for the kidney transplant patients may help to optimise the long-term outcomes of these transplants
Detailed description
This study will be undertaken using a prospective, multidimensional design. 42 nonadherent kidney transplant patients will be included in the intervention group. The nonadherent patients will be identified through Imperial College Renal and Transplant Centre (ICRTC) Outpatient Clinic based at Hammersmith Hospital. Standard and transplant specific demographics will be collected for all patients. All kidney transplant patients have their tacrolimus levels measured at each clinic visit. The variability of these levels can be used as a marker of their adherence. Patients with a high intrapatient variability (IPV) of their levels are said to be nonadherent. The Chief Investigator or another member of the research team will approach individual patients directly in the transplant out-patient clinic where they are members of the multidisciplinary clinical care team. The Chief Investigator or another member of the research team may also telephone patients to invite them to clinic to discuss participation in the trial. The Chief Investigator or another member of the research team will describe the study to the patient, answer any questions they have and provide them with a participant information sheet (PIS). Patients will be given the opportunity to take the PIS away and think about whether they would like to participate. A follow up discussion either in clinic or on the phone will be arranged with the patient to answer any queries they have within two weeks of providing them with the PIS; during that discussion, the Chief Investigator or other member of the research team will arrange an appointment in the transplant clinic with the patient to sign the consent form if they do decide to participate. Patients recruited into the study will receive pharmacist led, patient tailored interventions to improve immunosuppressant medication adherence. Patients will be included in the study for one year from recruitment.
The pharmacist led, patient tailored intervention will involve regular, intensive, personalised support from a pharmacist to improve adherence to immunosuppressive medications. The pharmacist will meet with the patient on a regular basis in the transplant clinic to identify their perceptual and practical barriers to adherence and agree a support plan that is tailored to them.
Within the first two weeks of recruitment, the study pharmacist will meet with the patient in transplant clinic to:
- Undertake a full medication history
- Discuss self-reported medication nonadherence
- Undertake the BAASIS questionnaire
- Ask the patient to complete a Beliefs about Medicines Questionnaire (BMQ)
- Undertake a socioeconomic and educational assessment
- Undertake to gain collateral reporting of nonadherence by clinicians, relatives, friends or carers
- Perform a tacrolimus pill count
- Check in-house dispensing records of tacrolimus
- Identify barriers to adherence
- Tailor interventions and support to the needs of the patient
- Complete a motivational interview
- Agree to meet again during an outpatient clinic visit within an agreed time which is appropriate for the patient needs and within 3 months.
This first visit will provide a baseline assessment of the patient's medication adherence.
Tailored support may include:
- Setting alarms
- Medication diary card or calendar
- Medication compliance aid filled by the patient, family/carers or by a pharmacy professional
- Adherence app
- Reducing the complexity of the medication regime
- Positioning medication within their daily routine eg. by toothbrush
- Changing formulations
- Additional education regarding need for medication / timing of doses
- Referral to a social worker to assist with affordability of medicines
- Referral to a psychologist to explore deeper psychological issues regarding medicines taking
The structure of each follow up adherence review will be the same as the first formal adherence review with the exception that the BMQ will only be repeated at the end of the one year follow-up and the socioeconomic and educational assessment will only be undertaken at the first assessment review. Every patient will have a formal adherence assessment at recruitment and then at 3, 6, 9 and 12 months. At the end of one year of follow-up, the specific benefits perceived by the patient of intensive adherence support from a pharmacist will be determined through a questionnaire.
Baseline nonadherence will be measured at the first visit with the study pharmacist within two weeks of recruitment and then at 3, 6, 9 and 12 months. The IPV of their tacrolimus levels and their outpatient clinic nonattendance rate will be measured retrospectively in the 12 months prior to recruitment to the study and then prospectively at the end of the intervention year. The IPV is calculated from the tacrolimus levels measured for an individual patient using the coefficient of variance mathematical formula - Coefficient of variance (COV) defined as: SD x 100 / Mean. The outpatient clinic nonattendance for each participant will be taken from the hospital integrated computer system.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medication adherence interventions | Other | Behavioral: Pharmacist led medication adherence interventionsPharmacist led medication adherence interventions which will be tailored to individual patient need |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult kidney transplant patients (18 years of age and above)
- Kidney transplant patients with an IPV of tacrolimus levels of greater than 18.15% in the previous 12 months
Key exclusion criteria (6 listed)
- Antibody incompatible transplants including patients with preformed HLA and blood group incompatible
- Previous rejection
- Donor specific antibody positive
- HIV positive patients
- Simultaneous pancreas and kidney patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist led medication adherence interventionsMedication adherence interventions which will be tailored to individual patient need | Behavioural | Medication adherence interventions |
Primary outcome
Change in Number of Patients Being Adherent/Non-aherent After the Intervention
Time frame: One year
Immunosuppression Medication adherence will be assessed and compared using the BAASIS questionnaire at recruitment and at the end of the study. The BAASIS questionnaire is a closed question questionnaire (either adherent or non-adherent); it is validated for assessing immunosuppression nonadherence in transplant patients. Any patient answering yes to any of the questions is assessed to be nonadherent
Change in the Median IPV Before and After the Intervention
Time frame: One year
Intrapatient variability of tacrolimus levels will be measured and compared and reported as percentage difference
Change in Outpatient Clinic Nonattendance Rate Before and After the Intervention
Time frame: One year
Data for this outcome measure has not been analysed: originally the outpatient clinic nonattendance rate was to be assessed and compared during the 12 months prior to recruitment to the study and during the study
12 secondary outcomes
Biopsy Proven ACR / AMR
Time frame: One year
The Number of Readmissions
Time frame: One year
Donor Specific Antibody (DSA) or Transplant Glomerulopathy
Time frame: One year
Fibrosis, Hyalinosis, Calcineurin Inhibitor (CNI) Toxicity or Diabetic Change on Toxicity
Time frame: One year
Graft Loss
Time frame: One year
Death
Time frame: One year
Serum Creatinine
Time frame: One year
eGFR
Time frame: One year
Proteinuria
Time frame: One year
Haematocrit
Time frame: One year
Haemoglobin
Time frame: One year
Albumin
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19386076De Bleser L, Matteson M, Dobbels F, Russell C, De Geest S. Interventions to improve medication-adherence after transplantation: a systematic review. Transpl Int. 2009 Aug;22(8):780-97. doi: 10.1111/j.1432-2277.2009.00881.x. Epub 2009 Apr 6.
- Background: PubMed 19845597Kidney Disease: Improving Global Outcomes (KDIGO) Transplant Work Group. KDIGO clinical practice guideline for the care of kidney transplant recipients. Am J Transplant. 2009 Nov;9 Suppl 3:S1-155. doi: 10.1111/j.1600-6143.2009.02834.x.
- Background: PubMed 17109727Denhaerynck K, Steiger J, Bock A, Schafer-Keller P, Kofer S, Thannberger N, De Geest S. Prevalence and risk factors of non-adherence with immunosuppressive medication in kidney transplant patients. Am J Transplant. 2007 Jan;7(1):108-16. doi: 10.1111/j.1600-6143.2006.01611.x. Epub 2006 Nov 15.
- Background: PubMed 19133930Fine RN, Becker Y, De Geest S, Eisen H, Ettenger R, Evans R, Rudow DL, McKay D, Neu A, Nevins T, Reyes J, Wray J, Dobbels F. Nonadherence consensus conference summary report. Am J Transplant. 2009 Jan;9(1):35-41. doi: 10.1111/j.1600-6143.2008.02495.x.
- Background: PubMed 10372038Gaston RS, Hudson SL, Ward M, Jones P, Macon R. Late renal allograft loss: noncompliance masquerading as chronic rejection. Transplant Proc. 1999 Jun;31(4A):21S-23S. doi: 10.1016/s0041-1345(99)00118-9. No abstract available.
- Background: PubMed 17600393Morrissey PE, Flynn ML, Lin S. Medication noncompliance and its implications in transplant recipients. Drugs. 2007;67(10):1463-81. doi: 10.2165/00003495-200767100-00007.
- Background: PubMed 15964334Morrissey PE, Reinert S, Yango A, Gautam A, Monaco A, Gohh R. Factors contributing to acute rejection in renal transplantation: the role of noncompliance. Transplant Proc. 2005 Jun;37(5):2044-7. doi: 10.1016/j.transproceed.2005.03.017.
- Background: PubMed 20448067Prendergast MB, Gaston RS. Optimizing medication adherence: an ongoing opportunity to improve outcomes after kidney transplantation. Clin J Am Soc Nephrol. 2010 Jul;5(7):1305-11. doi: 10.2215/CJN.07241009. Epub 2010 May 6.
- Background: PubMed 18294158Schafer-Keller P, Steiger J, Bock A, Denhaerynck K, De Geest S. Diagnostic accuracy of measurement methods to assess non-adherence to immunosuppressive drugs in kidney transplant recipients. Am J Transplant. 2008 Mar;8(3):616-26. doi: 10.1111/j.1600-6143.2007.02127.x.
- Background: PubMed 26095765Wiebe C, Nevins TE, Robiner WN, Thomas W, Matas AJ, Nickerson PW. The Synergistic Effect of Class II HLA Epitope-Mismatch and Nonadherence on Acute Rejection and Graft Survival. Am J Transplant. 2015 Aug;15(8):2197-202. doi: 10.1111/ajt.13341. Epub 2015 Jun 11.
- Background: PubMed 22081892Sellares J, de Freitas DG, Mengel M, Reeve J, Einecke G, Sis B, Hidalgo LG, Famulski K, Matas A, Halloran PF. Understanding the causes of kidney transplant failure: the dominant role of antibody-mediated rejection and nonadherence. Am J Transplant. 2012 Feb;12(2):388-99. doi: 10.1111/j.1600-6143.2011.03840.x. Epub 2011 Nov 14.
- Background: PubMed 23032865Roberts DM, Jiang SH, Chadban SJ. The treatment of acute antibody-mediated rejection in kidney transplant recipients-a systematic review. Transplantation. 2012 Oct 27;94(8):775-83. doi: 10.1097/TP.0b013e31825d1587.
- Individual participant dataSharing planned: No
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Not yet recruiting
Assessing Psoriasis Treatment Outcomes
Psoriasis
Active, not recruiting
HERDA: Pharmacist-Led Culturally Adapted Intervention for Depression Medication Adherence
Depression
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Goodall principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist led medication adherence interventions in people with Medication Adherence and Kidney Transplantation, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Number of Patients Being Adherent/Non-aherent After the Intervention (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03892317, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.