Chronic Kidney DiseaseNCT01517841
Barriers to Peritoneal Dialysis Selection
An observational study of Chronic Kidney Disease, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to understand what prevents chronic kidney disease patients from making a timely decision about dialysis modality options. This understanding will allow us to develop and implement interventions to assist patients in this turning point so that they can make the right decision for them in a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2013
- Phase
- Observational
- 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
Study population: The study population will consist of patients with late stage CKD and ESRD patients who are cared for by nephrologists at MetroHealth Medical Center.
Who may be able to join
- All patients of age greater than or equal to 18 years at MHMC who are late stage CKD
Who cannot join
- Patients who have acute renal failure and then recover renal function to levels of eGFR (estimated glomerular filtration rate) 20 mL/min/1.73m2 and in whom the nephrologist feels will not progress to ESRD in 2 years
- Patients who are not candidates for peritoneal dialysis
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
MetroHealth Medical Center- Center for Reducing Health Disparities
Cleveland, Ohio, 44109
About this study
Official title: Barriers to Selection and Initiation of Peritoneal Dialysis in the United States
The purpose of this study is to understand what prevents chronic kidney disease patients from making a timely decision about dialysis modality options. This understanding will allow us to develop and implement interventions to assist patients in this turning point so that they can make the right decision for them in a timely enough manner so that each patient can start dialysis in the safest and best way for them. 200 later stage chronic kidney disease patients (20% or less of kidney function remaining) will be asked to participate in the study with the goal of having 150 patients participate in the study.
Hypotheses:
- 50 % of patients will have made a modality decision when interviewed and patients in the action stage of behavior will be more likely to make a modality selection than patients in earlier stages of behavior change. Barriers to modality selection will act at several levels including patient, provider and health system level and will vary by behavioral stage of change
- 10-15% of patients might choose home dialysis. Knowledge, self efficacy in terms of CKD, education, and income will likely be barriers to home dialysis choice.
- Conditions
- Chronic Kidney Disease
- Keywords
- peritoneal dialysis, modality choice, kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic kidney disease | Patients with chronic kidney disease (20% or less kidney function remaining. Patients with end stage renal disease who are currently receiving dialysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barriers to making a dialysis modality decision
Determine the proportion of patients that made a dialysis modality decision and determine the barriers to being able to make a decision. Determine the proportion of patients choosing home dialysis and barriers associated with choice of home dialysis therapy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ash Sehgal, MetroHealth Medical Center
- Investigators
- Suma Prakash, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517841
- Sponsor's protocol ID
- IRB11-00542
- Status last verified
- Jun 2018
- First submitted
- 20 Jan 2012
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers to Selection and Initiation of Peritoneal Dialysis in the United States
- ClinicalTrials.gov ID
- NCT01517841
- Acronym / sponsor ID
- IRB11-00542
- Conditions
- Chronic Kidney Disease
- Keywords
- peritoneal dialysis, modality choice, kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Jan 2012 (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.
The purpose of this study is to understand what prevents chronic kidney disease patients from making a timely decision about dialysis modality options. This understanding will allow us to develop and implement interventions to assist patients in this turning point so that they can make the right decision for them in a timely enough manner so that each patient can start dialysis in the safest and best way for them. 200 later stage chronic kidney disease patients (20% or less of kidney function remaining) will be asked to participate in the study with the goal of having 150 patients participate in the study.
Hypotheses:
- 50 % of patients will have made a modality decision when interviewed and patients in the action stage of behavior will be more likely to make a modality selection than patients in earlier stages of behavior change. Barriers to modality selection will act at several levels including patient, provider and health system level and will vary by behavioral stage of change
- 10-15% of patients might choose home dialysis. Knowledge, self efficacy in terms of CKD, education, and income will likely be barriers to home dialysis choice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease | – | –Patients with chronic kidney disease (20% or less kidney function remaining. Patients with end stage renal disease who are currently receiving dialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients with late stage CKD and ESRD patients who are cared for by nephrologists at MetroHealth Medical Center.
Key inclusion criteria (1 listed)
- All patients of age greater than or equal to 18 years at MHMC who are late stage CKD
Key exclusion criteria (3 listed)
- Patients who have acute renal failure and then recover renal function to levels of eGFR (estimated glomerular filtration rate) 20 mL/min/1.73m2 and in whom the nephrologist feels will not progress to ESRD in 2 years
- Patients who are not candidates for peritoneal dialysis
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Barriers to making a dialysis modality decision
Time frame: 1 year
Determine the proportion of patients that made a dialysis modality decision and determine the barriers to being able to make a decision. Determine the proportion of patients choosing home dialysis and barriers associated with choice of home dialysis therapy.
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 14 Jun 2018.
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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.
Suma Prakash, MD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by MetroHealth Medical Center 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 1 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 14 Jun 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?
Barriers to making a dialysis modality decision (time frame: 1 year). 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 14 Jun 2018.