Chronic Kidney DiseaseNCT01992926
Facilitating Anemia Treatment Risk Communication for Patients With Kidney Disease: Decision Aid Trial
A study testing interactive educational intervention in people with Chronic Kidney Disease and End Stage Renal Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
Anemia is a common complication of chronic kidney disease (CKD). In anemia of chronic kidney disease, patients suffer from low hemoglobin levels, which contribute to feelings of malaise and fatigue. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease, End Stage Renal Disease
- What is being tested?
- interactive educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Aug 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has Chronic Kidney Disease or End Stage Renal Disease
- Over 18, under 80 years of age
- Currently receiving care in the Vanderbilt Nephrology or Dialysis Clinics
- Receiving ESAs for anemia
- Speaks and can read English (no previous use of interpreter services)
- No significant visual impairment documented in medical record
Who cannot join
- Diagnosed cognitive disability
- Stated inability to converse and read fluently in English, or prior use of translation services
- Poor visual acuity
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Anemia is a common complication of chronic kidney disease (CKD). In anemia of chronic kidney disease, patients suffer from low hemoglobin levels, which contribute to feelings of malaise and fatigue. The current accepted practice is often to administer erythropoietin-stimulating agents (ESAs), which act like the body's natural hormones to stimulate the production of red blood cells from bone marrow. Although ESAs are widely used in CKD, recent evidence suggests that they are not as safe as previously thought. In this study, we seek to test a decision aid to be used when a patient visits his or her nephrologist at Vanderbilt. The objective of the decision aid is to reduce patient confusion, improve their satisfaction with their care, improve their knowledge of kidney disease, and ultimately bring more clarity to patients about a controversial but ubiquitous drug.
The decision aid will be about 1 page long and will include questions and information that might help the patient be more active and informed regarding the choice of a course of ESA therapy. We will ask patients to answer questions before and after their clinic visits regarding their satisfaction and confidence in their treatment and their knowledge of kidney disease; we will ask some of the same questions 3 months after the clinic visit. We will compare patients who are counseled using the decision aid to patients who are not. We anticipate total experiment running time to be approximately 5 months to recruit and follow up on all patients.
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease
- Being tested
- interactive educational intervention
- Keywords
- health literacy, health numeracy
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interactive educational interventionBehavioural
Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.
| Study group | Role | What they receive |
|---|---|---|
| interactive educational intervention | Active comparator | Physicians will use an interactive educational worksheet during the standard-of-care clinic visit. Receives: Behavioral: interactive educational intervention |
| control group | No intervention | Physicians will conduct the standard-of-care clinic visit as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in patient understanding of anemia and treatment options
Change from baseline in the following surveys/questionaires at 3 months:
- Anemia Knowledge Survey (PAKKD)
- Perceived Kidney Self-Management Scale (PKiSMS or PDiSMS for ESRD)
- Social Support Measure (MSPSS)
- Perceived Efficacy in Patient-Physician Interactions (PEPPI)
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionAug 2014
- Study completionAug 2014
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 Chronic Kidney DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerri Cavanaugh, Vanderbilt University
- Investigators
- Kerri Cavanaugh, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992926
- Sponsor's protocol ID
- 130784
- Status last verified
- Jan 2015
- First submitted
- 14 Nov 2013
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beach LB, Wild M, Ramachandran G, Ikizler HO, Cavanaugh KL. Protocol of a randomized controlled trial of an erythropoietin stimulating agent decision aid for anemia treatment in kidney disease. BMC Nephrol. 2016 Jul 18;17(1):86. doi: 10.1186/s12882-016-0301-z.
PubMed 27430294
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Anemia Treatment Risk Communication for Patients With Kidney Disease: Decision Aid Trial
- ClinicalTrials.gov ID
- NCT01992926
- Acronym / sponsor ID
- 130784
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease
- Keywords
- health literacy, health numeracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 25 Nov 2013 (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.
Anemia is a common complication of chronic kidney disease (CKD). In anemia of chronic kidney disease, patients suffer from low hemoglobin levels, which contribute to feelings of malaise and fatigue. The current accepted practice is often to administer erythropoietin-stimulating agents (ESAs), which act like the body's natural hormones to stimulate the production of red blood cells from bone marrow. Although ESAs are widely used in CKD, recent evidence suggests that they are not as safe as previously thought. In this study, we seek to test a decision aid to be used when a patient visits his or her nephrologist at Vanderbilt. The objective of the decision aid is to reduce patient confusion, improve their satisfaction with their care, improve their knowledge of kidney disease, and ultimately bring more clarity to patients about a controversial but ubiquitous drug.
The decision aid will be about 1 page long and will include questions and information that might help the patient be more active and informed regarding the choice of a course of ESA therapy. We will ask patients to answer questions before and after their clinic visits regarding their satisfaction and confidence in their treatment and their knowledge of kidney disease; we will ask some of the same questions 3 months after the clinic visit. We will compare patients who are counseled using the decision aid to patients who are not. We anticipate total experiment running time to be approximately 5 months to recruit and follow up on all patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interactive educational intervention | Active comparator | Behavioral: interactive educational interventionPhysicians will use an interactive educational worksheet during the standard-of-care clinic visit. |
| control group | No intervention | –Physicians will conduct the standard-of-care clinic visit as usual. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has Chronic Kidney Disease or End Stage Renal Disease
- Over 18, under 80 years of age
- Currently receiving care in the Vanderbilt Nephrology or Dialysis Clinics
- Receiving ESAs for anemia
- Speaks and can read English (no previous use of interpreter services)
Key exclusion criteria (3 listed)
- Diagnosed cognitive disability
- Stated inability to converse and read fluently in English, or prior use of translation services
- Poor visual acuity
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 |
|---|---|---|
| interactive educational interventionUse of a concise, literacy-sensitive, physician-led, educational interaction with the patient. | Behavioural | interactive educational intervention |
Primary outcome
change in patient understanding of anemia and treatment options
Time frame: baseline and 3 months
Change from baseline in the following surveys/questionaires at 3 months: * Anemia Knowledge Survey (PAKKD) * Perceived Kidney Self-Management Scale (PKiSMS or PDiSMS for ESRD) * Social Support Measure (MSPSS) * Perceived Efficacy in Patient-Physician Interactions (PEPPI)
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 22 Jan 2015.
- Derived from this study: PubMed 27430294Beach LB, Wild M, Ramachandran G, Ikizler HO, Cavanaugh KL. Protocol of a randomized controlled trial of an erythropoietin stimulating agent decision aid for anemia treatment in kidney disease. BMC Nephrol. 2016 Jul 18;17(1):86. doi: 10.1186/s12882-016-0301-z.
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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.
Kerri Cavanaugh, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interactive educational intervention in people with Chronic Kidney Disease and End Stage Renal Disease, run by Vanderbilt University 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 6 inclusion and 3 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 22 Jan 2015. 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 patient understanding of anemia and treatment options (time frame: baseline and 3 months). 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 NCT01992926, 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 22 Jan 2015.