CKDNCT04119570
CKD Report Card Pilot Trial
A study testing CKD Report Card in people with CKD, run by University of Chicago at 1 site in United States.
Trial summary
The investigators will study physician-patient communication at the UCMC nephrology fellow clinic and to test an intervention, the CKD Report Card, to improve that communication and patient knowledge of CKD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- CKD
- What is being tested?
- CKD Report Card
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2018to 15 Sep 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking adult patients (age 18 or older)
- Identified in the medical record as non-Hispanic Black or non- Hispanic White
- seen in University of Chicago nephrology clinic with a participating nephrologist
Who cannot join
- not able to communicate in English
- lacking ability to consent to study
- does not identify as non-Hispanic Black or non-Hispanic
- without chronic kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: Pilot and Trial of the Chronic Kidney Disease Report Card
The investigators will study physician-patient communication at the UCMC nephrology fellow clinic and to test an intervention, the CKD Report Card, to improve that communication and patient knowledge of CKD.
Read the detailed description
The goals of the study are to 1) characterize the effectiveness and patient-centeredness of patient-physician interaction during a nephrology clinic visit both with and without use of the CKD Report Card, and 2) to determine which physician and patient characteristics are associated with effective and patient centered communication. There will be block enrollment. For Nephrology physicians who agreed to participate will complete a baseline questionnaire. Research assistants will approach patients of participating providers in clinic waiting rooms, with the goal of enrolling patients for each provider For half of the study, investigators will enroll patients in the study and observe patient-physician communication and use a survey measure CKD knowledge pre-visit and post-visit. For the second half of the study, investigators will give participants the CKD Report Card, an investigator-developed handout, to use during the clinic visit. Investigators will observe patient-physician communication and use a survey to measure CKD knowledge pre-visit and post-visit. For both groups, eligible participants will give informed consent and will complete a baseline questionnaire; research assistants will place a digital audio-recording device in the examination room to record the patient-provider encounter. Following the medical encounter, research assistants will administered an interview with patients, assessing demographic, social, and behavioral characteristics, as well as their experience of care and ratings of provider communication.
- Conditions
- CKD
- Being tested
- CKD Report Card
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD Report CardBehavioural
The CKD Report Card is a handout based on a NKDEP Educational Sheet that includes basic information about kidney disease and spaces where patient can record information about their own kidney disease
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Participants will have their clinic visit as per usual care. |
| CKD Report Card | Active comparator | Participants will receive the CKD Report Card prior to the clinic visit. Receives: Behavioral: CKD Report Card |
What is being measured
The primary outcome is the main question the study is designed to answer.
CKD Knowledge
Kidney Disease Knowledge Survey (KiKs)
Measured: Change in CKD Knowledge from Baseline (pre-visit) to CKD Knowledge immediately post clinic visit (within 15-100 minutes post-clinic visit)
Secondary outcomes (2)
patient-physician interaction
Perceived efficacy in patient-physician interactions (PEPPI)
Measured: immediately post-nephrology clinic visit (on day of enrollment, within 15-100 minutes post-clinic visit)
communication assessment
communication assessment tool (CAT)
Measured: immediately post-nephrology clinic visit (on day of enrollment, within 15-100 minutes post-clinic visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start15 May 2018
- Primary completion15 Sep 2018
- Study completion15 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- During the first half of the study, participants will be surveyed and observed without the intervention. During the second half, participants will be surveyed and observed with the intervention (CKD Report Card)
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milda R. Saunders, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119570
- Sponsor's protocol ID
- 18-0283
- Status last verified
- May 2023
- First submitted
- 17 Sep 2019
- Last updated
- 6 May 2023
- 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot and Trial of the Chronic Kidney Disease Report Card
- ClinicalTrials.gov ID
- NCT04119570
- Acronym / sponsor ID
- 18-0283
- Conditions
- CKD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 15 Sep 2018 (actual)
- First posted
- 8 Oct 2019 (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.
The investigators will study physician-patient communication at the UCMC nephrology fellow clinic and to test an intervention, the CKD Report Card, to improve that communication and patient knowledge of CKD.
Detailed description
The goals of the study are to 1) characterize the effectiveness and patient-centeredness of patient-physician interaction during a nephrology clinic visit both with and without use of the CKD Report Card, and 2) to determine which physician and patient characteristics are associated with effective and patient centered communication. There will be block enrollment. For Nephrology physicians who agreed to participate will complete a baseline questionnaire. Research assistants will approach patients of participating providers in clinic waiting rooms, with the goal of enrolling patients for each provider For half of the study, investigators will enroll patients in the study and observe patient-physician communication and use a survey measure CKD knowledge pre-visit and post-visit. For the second half of the study, investigators will give participants the CKD Report Card, an investigator-developed handout, to use during the clinic visit. Investigators will observe patient-physician communication and use a survey to measure CKD knowledge pre-visit and post-visit. For both groups, eligible participants will give informed consent and will complete a baseline questionnaire; research assistants will place a digital audio-recording device in the examination room to record the patient-provider encounter. Following the medical encounter, research assistants will administered an interview with patients, assessing demographic, social, and behavioral characteristics, as well as their experience of care and ratings of provider communication.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- During the first half of the study, participants will be surveyed and observed without the intervention. During the second half, participants will be surveyed and observed with the intervention (CKD Report Card)
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –Participants will have their clinic visit as per usual care. |
| CKD Report Card | Active comparator | Behavioral: CKD Report CardParticipants will receive the CKD Report Card prior to the clinic visit. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English-speaking adult patients (age 18 or older)
- Identified in the medical record as non-Hispanic Black or non- Hispanic White
- seen in University of Chicago nephrology clinic with a participating nephrologist
Key exclusion criteria (4 listed)
- not able to communicate in English
- lacking ability to consent to study
- does not identify as non-Hispanic Black or non-Hispanic
- without chronic kidney disease
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 |
|---|---|---|
| CKD Report CardThe CKD Report Card is a handout based on a NKDEP Educational Sheet that includes basic information about kidney disease and spaces where patient can record information about their own kidney disease | Behavioural | CKD Report Card |
Primary outcome
CKD Knowledge
Time frame: Change in CKD Knowledge from Baseline (pre-visit) to CKD Knowledge immediately post clinic visit (within 15-100 minutes post-clinic visit)
Kidney Disease Knowledge Survey (KiKs)
2 secondary outcomes
patient-physician interaction
Time frame: immediately post-nephrology clinic visit (on day of enrollment, within 15-100 minutes post-clinic visit)
communication assessment
Time frame: immediately post-nephrology clinic visit (on day of enrollment, within 15-100 minutes post-clinic visit)
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 6 May 2023.
- Individual participant dataSharing planned: No
Related trials for CKD
RecruitingObservational study
Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors
Chronic Kidney Disease
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Chronic Kidney Disease
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.
Milda R. Saunders, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CKD Report Card in people with CKD, run by University of Chicago 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 3 inclusion and 4 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 6 May 2023. 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?
CKD Knowledge (time frame: Change in CKD Knowledge from Baseline (pre-visit) to CKD Knowledge immediately post clinic visit (within 15-100 minutes post-clinic visit)). 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 6 May 2023.