EfficacyDREAM-APDNCT04002440
Directed Use of REmote Patient Management System AMia to Achieve Prescribed Dry Weight
A study testing AMIA with SHARESOURCE Connectivity Platform and HomeChoice PRO in people with Efficacy and Safety Issues, run by University of California, San Diego at 2 sites in United States.
Trial summary
Among ambulatory peritoneal dialysis patients, does use of the Baxter AMIA peritoneal dialysis cycler with SHARESOURCE connectivity platform achieve dry weight targets better than use of the Baxter Home Choice Pro cycler. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Efficacy, Safety Issues
- What is being tested?
- AMIA with SHARESOURCE Connectivity Platform and HomeChoice PRO
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2018to Apr 2022
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged > 21 years with ESRD on peritoneal dialysis
Who cannot join
- Unable to commit to 12 months of monitoring.
- Unable to stand safely on scale for weight
- Hospitalization for heart failure, volume overload, or cardiovascular disease within the last 3 months.
- Peritonitis within the past 3 months.
- Not responsible for self-care of peritoneal dialysis (proxy care will be excluded).
- Patients residing in a nursing home or other institutionalized individuals.
- Inability or unwillingness to provide informed consent (lacks decision making capacity)
- Alcohol, substance use, or other social conditions which preclude close follow-up and reliable participation, in the opinion of the primary nephrology physician or study investigator.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Home Dialysis Therapies of San Diego
Chula Vista, California, 91915
Home Dialysis Therapies of San Diego
San Diego, California, 92131
About this study
Among ambulatory peritoneal dialysis patients, does use of the Baxter AMIA peritoneal dialysis cycler with SHARESOURCE connectivity platform achieve dry weight targets better than use of the Baxter Home Choice Pro cycler.
Read the detailed description
The remote patient management system Baxter AMIA automated peritoneal dialysis system with SHARESOURCE connectivity platform incorporates innovative technology (two-way remote connectivity, touch screen controls, voice guidance) to record patient treatments which are then able to be transmitted to their dialysis clinic for review and monitoring in near real-time. This has tremendous potential clinical utility given the struggles to achieve dry weights for most peritoneal dialysis patients using other systems, where typically, management regarding fluid balance is reviewed and revised only monthly. The new technology is the only device cleared in the US with patient-centric features. Abstracts available have demonstrated that AMIA can improve efficiency of patient training and focus PD nursing time towards proactive tasks to help patients. There has also been insight into how remote patient management systems like AMIA can be used to objectively monitor patient compliance or catheter function above and beyond subjective endorsement from patients. However, with new technology comes new training for patient and staff (nurses, physicians) without understanding if interfacing with this new patient-centric featured technology improves patient-centric clinical outcomes. The new AMIA and SHARESOURCE programs may also require additional nurse and physician provider time to monitor data in real-time and to react to these data, which may incur additional expense to medical practices. Thus, it is imperative to demonstrate the utility of the AMIA and SHARESOURCE programs for important improvement in patient management, which may ultimately translate into improved clinical outcomes (e.g. fewer hospital admissions, less heart failure, improved quality, and length of life).
- Conditions
- Efficacy, Safety Issues
- Being tested
- AMIA with SHARESOURCE Connectivity Platform, HomeChoice PRO
- Keywords
- Estimated Dry Weight, Peritoneal Dialysis, AMIA, Sharesource, CCPD, Peritoneal Dialysis Cycler, HomeChoice PRO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMIA with SHARESOURCE Connectivity PlatformCombination product
Also called Baxter AMIA, SHARESOURCE
The investigators will conduct a randomized, cross-over study in peritoneal dialysis patients in which patients are randomized to either Home Choice Pro (which remains the most widely used Baxter cycler) versus treatment with the Baxter AMIA automated peritoneal dialysis system with SHARESOURCE connectivity.
HomeChoice PRODevice
Also called Baxter HomeChoice PRO
Usual care
| Study group | Role | What they receive |
|---|---|---|
| AMIA with SHARESOURCE | Active comparator | For this arm, dialysis nurses will review those patients using the AMIA with SHARESOURCE connectivity platform twice a week and will contact patients who meet certain triggers. They will then offer patients interventions, ie. a change in the preset AMIA ultrafiltration program, in order to achieve prescribed dry weight. Receives: Combination Product: AMIA with SHARESOURCE Connectivity Platform |
| HomeChoice PRO | Placebo comparator | For this arm, routine standard of care for peritoneal dialysis patients will continue using the HomeChoice PRO device. Data regarding treatments will be captured on a chip to be analyzed at the end of 6 months to evaluate compliance with treatments. Receives: Device: HomeChoice PRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 month average of difference between the actual vs. prescribed dry weight
The investigators will evaluate the average difference between the actual dry weight vs. prescribed dry weight achieved through use of Baxter AMIA automated peritoneal dialysis system with SHARESOURCE connectivity compared to use of HomeChoicePRO.
Measured: 3 months
Secondary outcomes (2)
Nursing burden related to use of AMIA with SHARESOURCE
The investigators will observe the number of nursing time hours per month dedicated to patient care for patients using AMIA with SHARESOURCE compared to patients using HomeChoicePRO.
Measured: 12 months
Patient Quality of Life while using AMIA with SHARESOURCE: Kidney Disease and Quality of Life -36 questionaire
The investigators will assess quality of life scores using the Kidney Disease and Quality of Life -36 questionaire survey of patients using AMIA with SHARESOURCE compared to patients using HomeChoicePRO. The survey assesses 5 areas pertaining to quality of life on dialysis which include 1) physical component score 2) mental component score 3) burden 4) symptoms 5) effects. Patient answers are compared to their national demographic and reported on a scale of 0-100. The higher the score the better. The scores for each component will be reported and tracked separately.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start8 Nov 2018
- Primary completion30 Nov 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EfficacyStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be consented and then randomized to one of 2 modality groups; AMIA or HomeChoice PRO. Participants will receive PD care with randomized modality for 6 months, then cross-over to other modality for next 6 months. Nephrologists will see patients once a month. Each visit, the nephrologist will define the patient's desired dry weight (DW) at the subsequent visit. The primary end-point will be the average difference between actual DW vs. prescribed DW. The investigators envision a learning curve with each cycler change, and therefore have set the primary endpoint to average the final 3 visits, rather than using all 6 visits. All solutions and supplies will be from Baxter. Labs will be obtained monthly and quarterly per routine. Dialysis RN will review patients on AMIA twice a week and contact those off target DW and offer interventions to achieve prescribed DW. HomeChoice PRO will record data on a chip analyzed at the end of 6 months to evaluate compliance.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Scripps Health, Home Dialysis Therapies of San Diego
- Responsible party
- Principal investigator, Joachim H. Ix, University of California, San Diego
- Investigators
- Joachim H Ix, MD, MAS, Principal investigator, University of California, San DiegoBethany E Karl, DO, Study director, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002440
- Sponsor's protocol ID
- 180492
- Acronym
- DREAM-APD
- Status last verified
- Aug 2021
- First submitted
- 11 Oct 2018
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Directed Use of REmote Patient Management System AMia to Achieve Prescribed Dry Weight
- ClinicalTrials.gov ID
- NCT04002440
- Acronym / sponsor ID
- DREAM-APD / 180492
- Conditions
- Efficacy, Safety Issues
- Keywords
- Estimated Dry Weight, Peritoneal Dialysis, AMIA, Sharesource, CCPD, Peritoneal Dialysis Cycler, HomeChoice PRO
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Scripps Health, Home Dialysis Therapies of San Diego
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 28 Jun 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.
Among ambulatory peritoneal dialysis patients, does use of the Baxter AMIA peritoneal dialysis cycler with SHARESOURCE connectivity platform achieve dry weight targets better than use of the Baxter Home Choice Pro cycler.
Detailed description
The remote patient management system Baxter AMIA automated peritoneal dialysis system with SHARESOURCE connectivity platform incorporates innovative technology (two-way remote connectivity, touch screen controls, voice guidance) to record patient treatments which are then able to be transmitted to their dialysis clinic for review and monitoring in near real-time. This has tremendous potential clinical utility given the struggles to achieve dry weights for most peritoneal dialysis patients using other systems, where typically, management regarding fluid balance is reviewed and revised only monthly. The new technology is the only device cleared in the US with patient-centric features. Abstracts available have demonstrated that AMIA can improve efficiency of patient training and focus PD nursing time towards proactive tasks to help patients. There has also been insight into how remote patient management systems like AMIA can be used to objectively monitor patient compliance or catheter function above and beyond subjective endorsement from patients. However, with new technology comes new training for patient and staff (nurses, physicians) without understanding if interfacing with this new patient-centric featured technology improves patient-centric clinical outcomes. The new AMIA and SHARESOURCE programs may also require additional nurse and physician provider time to monitor data in real-time and to react to these data, which may incur additional expense to medical practices. Thus, it is imperative to demonstrate the utility of the AMIA and SHARESOURCE programs for important improvement in patient management, which may ultimately translate into improved clinical outcomes (e.g. fewer hospital admissions, less heart failure, improved quality, and length of life).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be consented and then randomized to one of 2 modality groups; AMIA or HomeChoice PRO. Participants will receive PD care with randomized modality for 6 months, then cross-over to other modality for next 6 months. Nephrologists will see patients once a month. Each visit, the nephrologist will define the patient's desired dry weight (DW) at the subsequent visit. The primary end-point will be the average difference between actual DW vs. prescribed DW. The investigators envision a learning curve with each cycler change, and therefore have set the primary endpoint to average the final 3 visits, rather than using all 6 visits. All solutions and supplies will be from Baxter. Labs will be obtained monthly and quarterly per routine. Dialysis RN will review patients on AMIA twice a week and contact those off target DW and offer interventions to achieve prescribed DW. HomeChoice PRO will record data on a chip analyzed at the end of 6 months to evaluate compliance.
| Arm | Type | Receives |
|---|---|---|
| AMIA with SHARESOURCE | Active comparator | Combination Product: AMIA with SHARESOURCE Connectivity PlatformFor this arm, dialysis nurses will review those patients using the AMIA with SHARESOURCE connectivity platform twice a week and will contact patients who meet certain triggers. They will then offer patients interventions, ie. a change in the preset AMIA ultrafiltration program, in order to achieve prescribed dry weight. |
| HomeChoice PRO | Placebo comparator | Device: HomeChoice PROFor this arm, routine standard of care for peritoneal dialysis patients will continue using the HomeChoice PRO device. Data regarding treatments will be captured on a chip to be analyzed at the end of 6 months to evaluate compliance with treatments. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged > 21 years with ESRD on peritoneal dialysis
Key exclusion criteria (8 listed)
- Unable to commit to 12 months of monitoring.
- Unable to stand safely on scale for weight
- Hospitalization for heart failure, volume overload, or cardiovascular disease within the last 3 months.
- Peritonitis within the past 3 months.
- Not responsible for self-care of peritoneal dialysis (proxy care will be excluded).
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 |
|---|---|---|
| AMIA with SHARESOURCE Connectivity PlatformAlso: Baxter AMIA, SHARESOURCEThe investigators will conduct a randomized, cross-over study in peritoneal dialysis patients in which patients are randomized to either Home Choice Pro (which remains the most widely used Baxter cycler) versus treatment with the Baxter AMIA automated peritoneal dialysis system with SHARESOURCE connectivity. | Combination product | AMIA with SHARESOURCE |
| HomeChoice PROAlso: Baxter HomeChoice PROUsual care | Device | HomeChoice PRO |
Primary outcome
3 month average of difference between the actual vs. prescribed dry weight
Time frame: 3 months
The investigators will evaluate the average difference between the actual dry weight vs. prescribed dry weight achieved through use of Baxter AMIA automated peritoneal dialysis system with SHARESOURCE connectivity compared to use of HomeChoicePRO.
2 secondary outcomes
Nursing burden related to use of AMIA with SHARESOURCE
Time frame: 12 months
Patient Quality of Life while using AMIA with SHARESOURCE: Kidney Disease and Quality of Life -36 questionaire
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Joachim H Ix, MD, MAS principal investigator
University of California, San Diego
Bethany E Karl, DO study director
University of California, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMIA with SHARESOURCE Connectivity Platform and HomeChoice PRO in people with Efficacy and Safety Issues, run by University of California, San Diego at 2 sites 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 8 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: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
3 month average of difference between the actual vs. prescribed dry weight (time frame: 3 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 25 Aug 2021.