Chronic Kidney DiseasePhase 3NCT01446029
Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease (CKD)
A Phase 3 study testing Video Telemonitoring Device with Clinical Care Modules in people with Chronic Kidney Disease, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if the adoption of a chronic care model in conjunction with tele monitoring and case management can reduce the risk of death, hospitalization, emergency room visits, or admission to a skilled nursing facility in patients with chronic kidney disease compared to usual care. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Video Telemonitoring Device with Clinical Care Modules
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 601 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Oct 2013
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Enrolled at Minneapolis or St. Cloud Veterans Affairs Health Care System (VAHCS) or affiliated Community Based Outcomes Clinic(CBOC); Late eGFR within the VA system <60 ml/min/1.73m2 -
Exclusion Criteria: Primary care provider unwilling to have participant included in study; unable to give consent; severe mental health condition; living in a nursing home
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease
The purpose of this study is to determine if the adoption of a chronic care model in conjunction with tele monitoring and case management can reduce the risk of death, hospitalization, emergency room visits, or admission to a skilled nursing facility in patients with chronic kidney disease compared to usual care.
Read the detailed description
Chronic kidney disease (CKD) is a major public health issue. Approximately, 11% of the US population has CKD with an increased prevalence among individuals great than 65years. Many individuals with CKD go unrecognized because they are typically asymptomatic. Individuals with CKD have been demonstrated to have a greater risk for mortality, hospitalization and development of end stage kidney disease. Also, individuals with CKD consume a significantly greater proportion of health care expenditures compared to other patients. This study aims to determine if the adoption of a chronic care model in conjunction with telemonitoring and case management can reduce risk of death, hospitalization, ER visits or admission to a skilled nursing facility in patients with CKD compared to usual care. This study will use a randomized controlled trial. Few interventions have been demonstrated to improve clinical outcomes in patients with CKD. If successful, this study will enable the VA to provide high quality care to patients with CKD while potentially reducing the cost of providing care.
- Conditions
- Chronic Kidney Disease
- Being tested
- Video Telemonitoring Device with Clinical Care Modules
- Keywords
- Telemonitoring, Chronic Kidney Disease
- 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.
Video Telemonitoring Device with Clinical Care ModulesDevice
Also called Telehealth, Telemonitoring, Chronic Disease Management
Telemonitoring of vital signs; videoconferencing, remote titration of diabetes, blood pressure, and lipid medications using evidence based treatment algorithm, and cooperative goal setting using education modules to enhance lifestyle changes
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Not described |
| Intervention Device | Active comparator | Not described Receives: Device: Video Telemonitoring Device with Clinical Care Modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility)
Measured: one year
Secondary outcomes (4)
reduction of cost
Measured: one year
incidence of end stage kidney disease
Measured: one year
hospital re-admission
Measured: one year
Intervention group achieving National Kidney guideline values for blood pressure, glycemia, lipids, and hemoglobin
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2011 (estimated)
- Study startMar 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Areef Ishani, Minneapolis Veterans Affairs Medical Center
- Investigators
- Areef Ishani, MD, Principal investigator, US Department of Veterans Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446029
- Sponsor's protocol ID
- Minn-VAMC-4292-A
- Status last verified
- Aug 2014
- First submitted
- 28 Sep 2011
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barrett BJ, Garg AX, Goeree R, Levin A, Molzahn A, Rigatto C, Singer J, Soltys G, Soroka S, Ayers D, Parfrey PS. A nurse-coordinated model of care versus usual care for stage 3/4 chronic kidney disease in the community: a randomized controlled trial. Clin J Am Soc Nephrol. 2011 Jun;6(6):1241-7. doi: 10.2215/CJN.07160810. Epub 2011 May 26.
PubMed 21617090Ishani A, Greer N, Taylor BC, Kubes L, Cole P, Atwood M, Clothier B, Ercan-Fang N. Effect of nurse case management compared with usual care on controlling cardiovascular risk factors in patients with diabetes: a randomized controlled trial. Diabetes Care. 2011 Aug;34(8):1689-94. doi: 10.2337/dc10-2121. Epub 2011 Jun 2.
PubMed 21636796Santschi V, Chiolero A, Burnand B, Colosimo AL, Paradis G. Impact of pharmacist care in the management of cardiovascular disease risk factors: a systematic review and meta-analysis of randomized trials. Arch Intern Med. 2011 Sep 12;171(16):1441-53. doi: 10.1001/archinternmed.2011.399.
PubMed 21911628
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemonitoring to Improve Outcomes of Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01446029
- Acronym / sponsor ID
- Minn-VAMC-4292-A
- Conditions
- Chronic Kidney Disease
- Keywords
- Telemonitoring, Chronic Kidney Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Study start
- Mar 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 4 Oct 2011 (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 determine if the adoption of a chronic care model in conjunction with tele monitoring and case management can reduce the risk of death, hospitalization, emergency room visits, or admission to a skilled nursing facility in patients with chronic kidney disease compared to usual care.
Detailed description
Chronic kidney disease (CKD) is a major public health issue. Approximately, 11% of the US population has CKD with an increased prevalence among individuals great than 65years. Many individuals with CKD go unrecognized because they are typically asymptomatic. Individuals with CKD have been demonstrated to have a greater risk for mortality, hospitalization and development of end stage kidney disease. Also, individuals with CKD consume a significantly greater proportion of health care expenditures compared to other patients. This study aims to determine if the adoption of a chronic care model in conjunction with telemonitoring and case management can reduce risk of death, hospitalization, ER visits or admission to a skilled nursing facility in patients with CKD compared to usual care. This study will use a randomized controlled trial. Few interventions have been demonstrated to improve clinical outcomes in patients with CKD. If successful, this study will enable the VA to provide high quality care to patients with CKD while potentially reducing the cost of providing care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | – |
| Intervention Device | Active comparator | Device: Video Telemonitoring Device with Clinical Care Modules |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Video Telemonitoring Device with Clinical Care ModulesAlso: Telehealth, Telemonitoring, Chronic Disease ManagementTelemonitoring of vital signs; videoconferencing, remote titration of diabetes, blood pressure, and lipid medications using evidence based treatment algorithm, and cooperative goal setting using education modules to enhance lifestyle changes | Device | Intervention Device |
Primary outcome
composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility)
Time frame: one year
4 secondary outcomes
reduction of cost
Time frame: one year
incidence of end stage kidney disease
Time frame: one year
hospital re-admission
Time frame: one year
Intervention group achieving National Kidney guideline values for blood pressure, glycemia, lipids, and hemoglobin
Time frame: one year
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 4 Aug 2014.
- Background: PubMed 21617090Barrett BJ, Garg AX, Goeree R, Levin A, Molzahn A, Rigatto C, Singer J, Soltys G, Soroka S, Ayers D, Parfrey PS. A nurse-coordinated model of care versus usual care for stage 3/4 chronic kidney disease in the community: a randomized controlled trial. Clin J Am Soc Nephrol. 2011 Jun;6(6):1241-7. doi: 10.2215/CJN.07160810. Epub 2011 May 26.
- Background: PubMed 21636796Ishani A, Greer N, Taylor BC, Kubes L, Cole P, Atwood M, Clothier B, Ercan-Fang N. Effect of nurse case management compared with usual care on controlling cardiovascular risk factors in patients with diabetes: a randomized controlled trial. Diabetes Care. 2011 Aug;34(8):1689-94. doi: 10.2337/dc10-2121. Epub 2011 Jun 2.
- Background: PubMed 21911628Santschi V, Chiolero A, Burnand B, Colosimo AL, Paradis G. Impact of pharmacist care in the management of cardiovascular disease risk factors: a systematic review and meta-analysis of randomized trials. Arch Intern Med. 2011 Sep 12;171(16):1441-53. doi: 10.1001/archinternmed.2011.399.
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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.
Areef Ishani, MD principal investigator
US Department of Veterans Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Video Telemonitoring Device with Clinical Care Modules in people with Chronic Kidney Disease, run by Minneapolis Veterans Affairs 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?
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 4 Aug 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
composite clinical outcome (reduce risk of death, hospitalization, emergency room visits, admission to skilled nursing facility) (time frame: one year). 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 NCT01446029, which also lists 3 linked publications.
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 4 Aug 2014.