Cardiovascular DiseasesNCT02763943
Improving Medication Safety and CVD Risk Factor Control in Kidney Transplant Recipients
A study testing Pharmacist-led, technology enabled education intervention in people with Cardiovascular Diseases and Diabetes Mellitus, run by Medical University of South Carolina at 1 site in United States.
Trial summary
There is a lack of data analyzing the influence of Cardio-vascular Diseases (CVD) risk factor control on graft survival disparities in Black transplant recipients. Studies in the general population indicate that CVD risk factor control is poor in Black patients, leading to higher rates of renal failure and CV events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Mellitus, Medication Adherence
- What is being tested?
- Pharmacist-led, technology enabled education intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2016to 22 Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age and able to give informed consent.
- Received a first or repeat cadaveric or living donor renal transplant.
- Patient has adequate graft function, defined as an estimated glomerular filtration rate (GFR) of at least 20 mL/min, using the 4-variable Modification of Diet in Renal Disease (MDRD) equation.
- Patient is at least one year post transplant.
- Patient has documented hypertension, defined as a sitting blood pressure of at least 140/90 mmHg or receiving any anti-hypertensive therapy.
- Patient has documented diabetes mellitus, defined as a hemoglobin A1c of at least 6.5% or receiving any anti-glycemic medications.
- Willing to comply with all study visits.
Who cannot join
- Biopsy proven acute rejection episode that occurred within the past month.
- Patients who have received an organ transplant other than a kidney.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Improving Medication Safety and Cardiovascular Risk Factor Control in Kidney Transplant Recipients
There is a lack of data analyzing the influence of Cardio-vascular Diseases (CVD) risk factor control on graft survival disparities in Black transplant recipients. Studies in the general population indicate that CVD risk factor control is poor in Black patients, leading to higher rates of renal failure and CV events. However, with the exception of hypertension, there is paucity in data demonstrating similar results within transplant recipients. Recent analyses conducted within our transplant program, indicate that CVD risk factors, especially diabetes, are poorly controlled in Black recipients, which likely impacts graft loss. Since these data were collected in a retrospective manner, larger analyses are needed to validate these exploratory findings.
This pilot study is to:
- Determine if the study is feasible, as measured by the proportions of enrolled to approached and completed to enrolled.
- Measure and compare, at baseline versus the end of the intervention, the medication safety events, including the number of medication errors, medication non-adherence and medication side effects, in patients enrolled in the study
- Measure and compare, at baseline versus the end of the intervention, CVD risk factor control, including hypertension, diabetes and dyslipidemia, in patients enrolled in the study
- Measure and compare, at baseline versus the end of the intervention, patient reported survey results, in patients enrolled in the study
- Determine if the impact of the intervention is more pronounced in Black recipients, as compared to non-Black recipients
- Being tested
- Pharmacist-led, technology enabled education intervention
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led, technology enabled education interventionBehavioural
Prospective, non-randomized, pilot study assessing the feasibility and potential efficacy of a 6-month, pharmacist-led, technology enabled education intervention on improving medication safety and cardiovascular risk factor control in adult solitary kidney transplant recipients with a secondary aim of assessing if the impact of the intervention varies by race.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure values from baseline to end of study
Blood pressure will be assessed using clinic measurements, taken three times, five minutes apart in the same arm and averaged.
Measured: 6 months
Change in HBA1C values from baseline to end of study
Measured: 6 months
Change in lipid values from baseline to end of study
Measured: 6 months
Medication adherence by comparing medication possession ratios (MPR) for the six months prior to enrollment compared to six months during the intervention
Measured: 1 year
Patient self-reported medication adherence at baseline compared to end of study.
The Morisky 8-item adherence score will be compared from baseline to end of study.
Measured: 6 months
Number of medication errors assessed at baseline and compared to errors at 6 months
Measured: 6 months
Medication side effects at baseline compared to end of study.
The Memphis side effect scale will be used to compare side effects from baseline to end of study.
Measured: 6 months
Patient reported survey results regarding self-care and health knowledge from baseline to end of study
Measured: 6 months
Patient reported survey results regarding psychosocial status from baseline to end of study
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 posted5 May 2016 (estimated)
- Study start1 Apr 2016
- Primary completion22 Jan 2018
- Study completion22 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763943
- Sponsor's protocol ID
- Pro00051804
- Status last verified
- Apr 2016
- First submitted
- 14 Mar 2016
- Last updated
- 12 Feb 2018
- Results posted
- No
Publications
Taber DJ, Gebregziabher M, Posadas A, Schaffner C, Egede LE, Baliga PK. Pharmacist-Led, Technology-Assisted Study to Improve Medication Safety, Cardiovascular Risk Factor Control, and Racial Disparities in Kidney Transplant Recipients. J Am Coll Clin Pharm. 2018 Dec;1(2):81-88. doi: 10.1002/jac5.1024. Epub 2018 Jun 21.
PubMed 30714026
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Medication Safety and Cardiovascular Risk Factor Control in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT02763943
- Acronym / sponsor ID
- Pro00051804
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 22 Jan 2018 (actual)
- First posted
- 5 May 2016 (estimated)
- 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.
There is a lack of data analyzing the influence of Cardio-vascular Diseases (CVD) risk factor control on graft survival disparities in Black transplant recipients. Studies in the general population indicate that CVD risk factor control is poor in Black patients, leading to higher rates of renal failure and CV events. However, with the exception of hypertension, there is paucity in data demonstrating similar results within transplant recipients. Recent analyses conducted within our transplant program, indicate that CVD risk factors, especially diabetes, are poorly controlled in Black recipients, which likely impacts graft loss. Since these data were collected in a retrospective manner, larger analyses are needed to validate these exploratory findings.
This pilot study is to:
- Determine if the study is feasible, as measured by the proportions of enrolled to approached and completed to enrolled.
- Measure and compare, at baseline versus the end of the intervention, the medication safety events, including the number of medication errors, medication non-adherence and medication side effects, in patients enrolled in the study
- Measure and compare, at baseline versus the end of the intervention, CVD risk factor control, including hypertension, diabetes and dyslipidemia, in patients enrolled in the study
- Measure and compare, at baseline versus the end of the intervention, patient reported survey results, in patients enrolled in the study
- Determine if the impact of the intervention is more pronounced in Black recipients, as compared to non-Black recipients
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age and able to give informed consent.
- Received a first or repeat cadaveric or living donor renal transplant.
- Patient has adequate graft function, defined as an estimated glomerular filtration rate (GFR) of at least 20 mL/min, using the 4-variable Modification of Diet in Renal Disease (MDRD) equation.
- Patient is at least one year post transplant.
- Patient has documented hypertension, defined as a sitting blood pressure of at least 140/90 mmHg or receiving any anti-hypertensive therapy.
Key exclusion criteria (2 listed)
- Biopsy proven acute rejection episode that occurred within the past month.
- Patients who have received an organ transplant other than a kidney.
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, technology enabled education interventionProspective, non-randomized, pilot study assessing the feasibility and potential efficacy of a 6-month, pharmacist-led, technology enabled education intervention on improving medication safety and cardiovascular risk factor control in adult solitary kidney transplant recipients with a secondary aim of assessing if the impact of the intervention varies by race. | Behavioural | – |
Primary outcome
Change in blood pressure values from baseline to end of study
Time frame: 6 months
Blood pressure will be assessed using clinic measurements, taken three times, five minutes apart in the same arm and averaged.
Change in HBA1C values from baseline to end of study
Time frame: 6 months
Change in lipid values from baseline to end of study
Time frame: 6 months
Medication adherence by comparing medication possession ratios (MPR) for the six months prior to enrollment compared to six months during the intervention
Time frame: 1 year
Patient self-reported medication adherence at baseline compared to end of study.
Time frame: 6 months
The Morisky 8-item adherence score will be compared from baseline to end of study.
Number of medication errors assessed at baseline and compared to errors at 6 months
Time frame: 6 months
Medication side effects at baseline compared to end of study.
Time frame: 6 months
The Memphis side effect scale will be used to compare side effects from baseline to end of study.
Patient reported survey results regarding self-care and health knowledge from baseline to end of study
Time frame: 6 months
Patient reported survey results regarding psychosocial status from baseline to end of study
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 12 Feb 2018.
- Derived from this study: PubMed 30714026Taber DJ, Gebregziabher M, Posadas A, Schaffner C, Egede LE, Baliga PK. Pharmacist-Led, Technology-Assisted Study to Improve Medication Safety, Cardiovascular Risk Factor Control, and Racial Disparities in Kidney Transplant Recipients. J Am Coll Clin Pharm. 2018 Dec;1(2):81-88. doi: 10.1002/jac5.1024. Epub 2018 Jun 21.
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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 Pharmacist-led, technology enabled education intervention in people with Cardiovascular Diseases and Diabetes Mellitus, run by Medical University of South Carolina at 1 site in United States.
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 7 inclusion and 2 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 12 Feb 2018. 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 States. 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?
Change in blood pressure values from baseline to end of study (time frame: 6 months). The study lists 9 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 NCT02763943, which also lists 1 linked publication.
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 12 Feb 2018.