Transplant;Failure,KidneyNCT04715412
Clinical Pharmacy Guided Patient Counselling and Adherence Support on Renal Transplant Recipients
A study testing patient counseling and adherence support in people with Transplant;Failure,Kidney, run by Future University in Egypt at 1 site in Egypt.
Trial summary
As a result of the shortage of donor organs and the close relationship between allograft or even life loss and non-adherence after kidney transplantation, improvement of patient adherence appears essential. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transplant;Failure,Kidney
- What is being tested?
- patient counseling and adherence support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years at least 1 year post-transplant to allow for stabilization of the prescribed immunosuppressant therapy (IST) regimen Independent of others for medication management and willing as well as able to repetitively visit the outpatient clinic for educational training \& data collection.
Who cannot join
- Pediatric Older than 65 years. Multi-organ transplant. Pregnant or lactating. Cancer patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Clinical Pharmacy Guided Patient Counseling and Adherence Support on Renal Transplant Recipients' Adherence and Health Outcomes
As a result of the shortage of donor organs and the close relationship between allograft or even life loss and non-adherence after kidney transplantation, improvement of patient adherence appears essential. So the current study aimed to monitor adherence barriers of renal transplant recipients and evaluate possible consequences of nonadherence on recipients' clinical outcomes as well as to implement a structured adherence management program consisting of intensified patient counselling and adherence support by a dedicated clinical pharmacist as an adjunct to standard post-transplant patient education carried out by transplant physicians to investigate the efficacy of the implemented program on patients adherence and health outcomes as compared to standard physician patient care. The study is a prospective self-controlled interventional study that recruited 69 living donors-renal transplant Patients attending the transplant clinic of Nasser institute and satisfying the inclusion criteria. On enrolment, patient-related baseline data that could determine and affect patients' adherence as well as patients' clinical outcomes were recorded. After all patients received the adjuvant adherence management program by the clinical pharmacist for 6 month, patients' health outcomes were re-evaluated to compare them to baseline data
- Conditions
- Transplant;Failure,Kidney
- Being tested
- patient counseling and adherence support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient counseling and adherence supportOther
Technical interventions include; identification of possible reasons for non-adherence, adherence support by developing simplified schedules for taking medications that were customized to individualized patient's lifestyle. Reminders for dose as well as tools/strategies the RTR may use to follow the dosing schedules if needed as pillbox were provided as needed
Clinical pharmacists' guided patient training was individualized, repetitive, covered 6 months, and included more aspects and provided practical hints and strategies for medication management.
Initial clinical pharmacist face-to-face session will be up to 60-minute then 30-minute follow-up sessions will be conducted monthly for 6 months during the scheduled post-transplant clinic visits as coordinated with the transplant physician to allow for single office visits for transplant related issues and comorbidities.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Other | The standard training sessions were conducted for individual patient by the transplant physician to explain rejections, infections and tumor risks, post-transplant medication. After discharge, all patients had scheduled follow-up visits at the outpatient clinic of the transplant center, where immune suppressant blood levels were measured and their dosing adjusted accordingly. Patients also had the opportunity to discuss any concern of their condition or drug therapy with the transplant physician in charge.
in addition to this standard transplant training, patients received intensified care by a dedicated clinical pharmacist combining educational and technical interventions aiming at achieving and maintaining adherence to his/her prescribed medication and improving health outcomes. Receives: Other: patient counseling and adherence support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specified clinical and educational outcome
Self-reported taking adherence [TA, percentage of doses taken in comparison to the total number of doses prescribed]. Patients will be classified as being adherent for those with TA ≥80 or non-adherent for those with TA <80
Measured: 6 months
Secondary outcomes (5)
Renal function
Serum creatinine mg/dL
Measured: 6 months
Renal function
BUN (blood urea nitrogen) mg/dL
Measured: 6 months
Renal function
Serum uric acid mg/dL Serum uric acid
Measured: 6 months
Serum trough Immunosuppressant level (C0)
Serum level of immunosuppressant
Measured: 6 months
CBC
blood sample to asses (RBCs, WBCs and platelets)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start10 Mar 2020
- Primary completion11 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant;Failure,KidneyStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Doaa Mohamed Salah ElDin Diab ELBohy, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715412
- Sponsor's protocol ID
- REC-ASU No 10
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Clinical Pharmacy Guided Patient Counseling and Adherence Support on Renal Transplant Recipients' Adherence and Health Outcomes
- ClinicalTrials.gov ID
- NCT04715412
- Acronym / sponsor ID
- REC-ASU No 10
- Conditions
- Transplant;Failure,Kidney
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As a result of the shortage of donor organs and the close relationship between allograft or even life loss and non-adherence after kidney transplantation, improvement of patient adherence appears essential. So the current study aimed to monitor adherence barriers of renal transplant recipients and evaluate possible consequences of nonadherence on recipients' clinical outcomes as well as to implement a structured adherence management program consisting of intensified patient counselling and adherence support by a dedicated clinical pharmacist as an adjunct to standard post-transplant patient education carried out by transplant physicians to investigate the efficacy of the implemented program on patients adherence and health outcomes as compared to standard physician patient care. The study is a prospective self-controlled interventional study that recruited 69 living donors-renal transplant Patients attending the transplant clinic of Nasser institute and satisfying the inclusion criteria. On enrolment, patient-related baseline data that could determine and affect patients' adherence as well as patients' clinical outcomes were recorded. After all patients received the adjuvant adherence management program by the clinical pharmacist for 6 month, patients' health outcomes were re-evaluated to compare them to baseline data
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Other | Other: patient counseling and adherence supportThe standard training sessions were conducted for individual patient by the transplant physician to explain rejections, infections and tumor risks, post-transplant medication. After discharge, all patients had scheduled follow-up visits at the outpatient clinic of the transplant center, where immune suppressant blood levels were measured and their dosing adjusted accordingly. Patients also had the opportunity to discuss any concern of their condition or drug therapy with the transplant physician in charge. in addition to this standard transplant training, patients received intensified care by a dedicated clinical pharmacist combining educational and technical interventions aiming at achieving and maintaining adherence to his/her prescribed medication and improving health outcomes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- >18 years at least 1 year post-transplant to allow for stabilization of the prescribed immunosuppressant therapy (IST) regimen Independent of others for medication management and willing as well as able to repetitively visit the outpatient clinic for educational training \& data collection.
Key exclusion criteria (1 listed)
- Pediatric Older than 65 years. Multi-organ transplant. Pregnant or lactating. Cancer 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 |
|---|---|---|
| patient counseling and adherence supportTechnical interventions include; identification of possible reasons for non-adherence, adherence support by developing simplified schedules for taking medications that were customized to individualized patient's lifestyle. Reminders for dose as well as tools/strategies the RTR may use to follow the dosing schedules if needed as pillbox were provided as needed Clinical pharmacists' guided patient training was individualized, repetitive, covered 6 months, and included more aspects and provided practical hints and strategies for medication management. Initial clinical pharmacist face-to-face session will be up to 60-minute then 30-minute follow-up sessions will be conducted monthly for 6 months during the scheduled post-transplant clinic visits as coordinated with the transplant physician to allow for single office visits for transplant related issues and comorbidities. | Other | Study group |
Primary outcome
Specified clinical and educational outcome
Time frame: 6 months
Self-reported taking adherence [TA, percentage of doses taken in comparison to the total number of doses prescribed]. Patients will be classified as being adherent for those with TA ≥80 or non-adherent for those with TA <80
5 secondary outcomes
Renal function
Time frame: 6 months
Renal function
Time frame: 6 months
Renal function
Time frame: 6 months
Serum trough Immunosuppressant level (C0)
Time frame: 6 months
CBC
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient counseling and adherence support in people with Transplant;Failure,Kidney, run by Future University in Egypt at 1 site in Egypt.
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 1 inclusion and 1 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 20 Jan 2021. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Specified clinical and educational outcome (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2021.