Chronic Kidney DiseaseNCT02085837
Healthy Transitions in Late Stage Kidney Disease
A study testing Education, Daily weight measurement and monitoring and Universal Dietary education in people with Chronic Kidney Disease, run by Northwell Health at 1 site in United States.
Trial summary
Improve health and outcome for people with late stage chronic kidney disease by providing patient centered nursing services in addition to a Nephrologist's routine patient care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Education, Daily weight measurement and monitoring and Universal Dietary education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2016
- 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
- Stage 4-5 Chronic Kidney Disease (CKD), defined as estimated glomerular filtration rate (eGFR) between 0-30 ml/minute
- 18 years of age or older
Who cannot join
- Cognitive impairment that is clinically apparent
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Kidney diseases and Hypertension
Great Neck, New York, 11021
About this study
Official title: An Open Label Randomized Controlled Study to Compare the Impact of Patient Centered Nursing Services in Addition to a Nephrologist's Usual Patient Care With Usual Nephrologist's Care in Late Stage Chronic Kidney Disease Patients.
Improve health and outcome for people with late stage chronic kidney disease by providing patient centered nursing services in addition to a Nephrologist's routine patient care.
- Conditions
- Chronic Kidney Disease
- Being tested
- Education, Daily weight measurement and monitoring, Universal Dietary education, Medication review, Focused advanced directive program
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Additional education will be provided by nurses to improve communication and reduce fragmentation of care.
Daily weight measurement and monitoringOther
Monitor weight to avoid problems related to hypervolemia.
Universal Dietary educationOther
To improve diet and health
Medication reviewOther
Medication will be reviewed by nurses to detect any discrepancies to reduce medication error.
Focused advanced directive programOther
Education will be provided to increase awareness and encourage patients to have advanced directive.
Countdown to fistula programOther
To reduce the number of patients starting dialysis with catheter in place, comprehensive stepwise intervention will be provided by nurses to ensure arterio-venous (AV) fistula placement in all appropriate patients, with coordinated follow up and failure recovery processes.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Transitions Group | Experimental | * Additional nursing services will be provided to this group in addition to a usual care by Nephrologist.
* Daily weight measurement and monitoring
* Medication review
* Universal dietary education
* Focused advanced directive program
* Countdown to fistula program Receives: Other: Education; Other: Daily weight measurement and monitoring; Other: Universal Dietary education; Other: Medication review; Other: Focused advanced directive program; Other: Countdown to fistula program |
| Usual Care Group | No intervention | Usual care by nephrologist. No additional nursing support services will be provide to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization rate
Reduction in hospitalization rate in intervention group as compare to control group.
Measured: 18 months
Secondary outcomes (2)
Improve hemodialysis access rates
Percentage of patients with AVF, AVG or catheters
Measured: 18 months
Home dialysis
Increase choice of home dialysis as modality of treatment
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionJul 2014
- Study completionJan 2016
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.
- More trials run by Northwell HealthThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Fishbane, Northwell Health
- Investigators
- Steven Fishbane, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085837
- Sponsor's protocol ID
- 13-033
- Status last verified
- Jan 2017
- First submitted
- 7 Mar 2014
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Randomized Controlled Study to Compare the Impact of Patient Centered Nursing Services in Addition to a Nephrologist's Usual Patient Care With Usual Nephrologist's Care in Late Stage Chronic Kidney Disease Patients.
- ClinicalTrials.gov ID
- NCT02085837
- Acronym / sponsor ID
- 13-033
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 13 Mar 2014 (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.
Improve health and outcome for people with late stage chronic kidney disease by providing patient centered nursing services in addition to a Nephrologist's routine patient care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Transitions Group | Experimental | Other: Education, Other: Daily weight measurement and monitoring, Other: Universal Dietary education, Other: Medication review, Other: Focused advanced directive program, Other: Countdown to fistula program* Additional nursing services will be provided to this group in addition to a usual care by Nephrologist. * Daily weight measurement and monitoring * Medication review * Universal dietary education * Focused advanced directive program * Countdown to fistula program |
| Usual Care Group | No intervention | –Usual care by nephrologist. No additional nursing support services will be provide to this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stage 4-5 Chronic Kidney Disease (CKD), defined as estimated glomerular filtration rate (eGFR) between 0-30 ml/minute
- 18 years of age or older
Key exclusion criteria (1 listed)
- Cognitive impairment that is clinically apparent
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 |
|---|---|---|
| EducationAdditional education will be provided by nurses to improve communication and reduce fragmentation of care. | Other | Healthy Transitions Group |
| Daily weight measurement and monitoringMonitor weight to avoid problems related to hypervolemia. | Other | Healthy Transitions Group |
| Universal Dietary educationTo improve diet and health | Other | Healthy Transitions Group |
| Medication reviewMedication will be reviewed by nurses to detect any discrepancies to reduce medication error. | Other | Healthy Transitions Group |
| Focused advanced directive programEducation will be provided to increase awareness and encourage patients to have advanced directive. | Other | Healthy Transitions Group |
| Countdown to fistula programTo reduce the number of patients starting dialysis with catheter in place, comprehensive stepwise intervention will be provided by nurses to ensure arterio-venous (AV) fistula placement in all appropriate patients, with coordinated follow up and failure recovery processes. | Other | Healthy Transitions Group |
Primary outcome
Hospitalization rate
Time frame: 18 months
Reduction in hospitalization rate in intervention group as compare to control group.
2 secondary outcomes
Improve hemodialysis access rates
Time frame: 18 months
Home dialysis
Time frame: 18 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 5 Jan 2017.
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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.
Steven Fishbane, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education, Daily weight measurement and monitoring and Universal Dietary education in people with Chronic Kidney Disease, run by Northwell Health 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 2 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 5 Jan 2017. 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?
Hospitalization rate (time frame: 18 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 5 Jan 2017.