Compliance, PatientNCT04157764
Improve Compliance in Automated Peritoneal Dialysis Machine With SHARESOURCE
A study testing HomeChoice Claria APD machine with SHARESOURCE in people with Compliance, Patient, run by E-DA Hospital.
Trial summary
This study is to investigate the non-compliance rate of patients undergoing automated peritoneal dialysis by using automated peritoneal dialysis with SHARESOURCE software, and to evaluate if telemonitoring can improve peritoneal dialysis compliance and outcomes in the observation period. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Compliance, Patient
- What is being tested?
- HomeChoice Claria APD machine with SHARESOURCE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 31 Jan 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- stable received peritoneal dialysis for over 1 year. Use automated peritoneal dialysis machine regularly by him/herself.
Who cannot join
- Acute hospitalization events due to acute coronary syndrome, stroke, heart failure, liver cirrhosis, systemic infection in 1 month.
- Life expectancy <1 year
- Peritoneal dialysis prescriptions will be scheduled or expected to change in 3 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact of Telemonitoring on Compliance and Outcomes of Patients Undergoing Automated Peritoneal Dialysis With SHARESOURCE
This study is to investigate the non-compliance rate of patients undergoing automated peritoneal dialysis by using automated peritoneal dialysis with SHARESOURCE software, and to evaluate if telemonitoring can improve peritoneal dialysis compliance and outcomes in the observation period.
Read the detailed description
The non-compliance of patients receiving automated peritoneal dialysis (APD) is around 10-20%, and was believed to be under-estimated. Recently, a two-way telehealth system, SHARESOURCE software, provide practitioners real-time monitoring and recording of the therapy of APD.
By using this APD with SHARESOURCE software, we want to investigate the non-compliance rate of patients undergoing automated peritoneal dialysis, want to see if it can improve peritoneal dialysis compliance and outcomes in the observation period.
- Conditions
- Compliance, Patient
- Being tested
- HomeChoice Claria APD machine with SHARESOURCE
- Keywords
- Telehealth, automated peritoneal dialysis
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HomeChoice Claria APD machine with SHARESOURCEDevice
HomeChoice Claria APD machine with SHARESOURCE software. SHARESOURCE is a software can telemonitor patients' compliance
| Study group | Role | What they receive |
|---|---|---|
| APD | Experimental | Not described Receives: Device: HomeChoice Claria APD machine with SHARESOURCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of baseline patients' non-compliance rate at 3 months
Non compliance rate was calculated by the days of non-compliance divided by days of APD therapy
Measured: baseline(between week 0 and 12) and 3 months(week 12 and week 24)
Secondary outcomes (6)
Change of baseline peritoneal dialysis adequacy at 3 and 6 months
Dialysis adequacy is to see if dialysis is enough
Measured: baseline, week 12 and week 24
Change of baseline uremic toxin level at 3 and 6 months
concentration of uremic toxins(ex: indoxyl sulfate, and p-cresyl sulfate)
Measured: baseline, week 12 and week 24
change of body composition analysis
body composition exam (Body Composition Monitor, Fresenius Medical Care, Bad Homburg, Germany) will be done
Measured: baseline, week 12 and week 24
peritonitis rate (patient-month)
calculate the number of peritonitis rate
Measured: follow up to week 60
Hospitalization rate
calculate the number of hospitalization rate
Measured: follow up to week 60
Change of telephone contact frequency
the telephone contact frequency (from patient to nurse) for peritoneal dialysis-related problems will be collected
Measured: baseline(between week 0 and 12) and 3 months(week 12 and week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start1 Feb 2020 (estimated)
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Compliance, PatientStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- use automated peritoneal dialysis machine without SHARESOURCE for 12 weeks, then use automated peritoneal dialysis machine with SHARESOURCE for 12 weeks
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04157764
- Sponsor's protocol ID
- EMRP108057
- Status last verified
- Nov 2019
- First submitted
- 14 Oct 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saran R, Robinson B, Abbott KC, Agodoa LYC, Bragg-Gresham J, Balkrishnan R, Bhave N, Dietrich X, Ding Z, Eggers PW, Gaipov A, Gillen D, Gipson D, Gu H, Guro P, Haggerty D, Han Y, He K, Herman W, Heung M, Hirth RA, Hsiung JT, Hutton D, Inoue A, Jacobsen SJ, Jin Y, Kalantar-Zadeh K, Kapke A, Kleine CE, Kovesdy CP, Krueter W, Kurtz V, Li Y, Liu S, Marroquin MV, McCullough K, Molnar MZ, Modi Z, Montez-Rath M, Moradi H, Morgenstern H, Mukhopadhyay P, Nallamothu B, Nguyen DV, Norris KC, O'Hare AM, Obi Y, Park C, Pearson J, Pisoni R, Potukuchi PK, Repeck K, Rhee CM, Schaubel DE, Schrager J, Selewski DT, Shamraj R, Shaw SF, Shi JM, Shieu M, Sim JJ, Soohoo M, Steffick D, Streja E, Sumida K, Kurella Tamura M, Tilea A, Turf M, Wang D, Weng W, Woodside KJ, Wyncott A, Xiang J, Xin X, Yin M, You AS, Zhang X, Zhou H, Shahinian V. US Renal Data System 2018 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2019 Mar;73(3 Suppl 1):A7-A8. doi: 10.1053/j.ajkd.2019.01.001. Epub 2019 Feb 21. No abstract available.
PubMed 30798791Bernardini J, Piraino B. Compliance in CAPD and CCPD patients as measured by supply inventories during home visits. Am J Kidney Dis. 1998 Jan;31(1):101-7. doi: 10.1053/ajkd.1998.v31.pm9428459.
PubMed 9428459The USRDS Dialysis Morbidity and Mortality Study: Wave 2. United States Renal Data System. Am J Kidney Dis. 1997 Aug;30(2 Suppl 1):S67-85. No abstract available.
PubMed 9259694Milan Manani S, Crepaldi C, Giuliani A, Virzi GM, Garzotto F, Riello C, de Cal M, Rosner MH, Ronco C. Remote Monitoring of Automated Peritoneal Dialysis Improves Personalization of Dialytic Prescription and Patient's Independence. Blood Purif. 2018;46(2):111-117. doi: 10.1159/000487703. Epub 2018 Apr 25.
PubMed 29694954Uchiyama K, Washida N, Yube N, Kasai T, Shinozuka K, Morimoto K, Hishikawa A, Inoue H, Urai H, Hagiwara A, Fujii K, Wakino S, Deenitchina S, Itoh H. The impact of a remote monitoring system of healthcare resource consumption in patients on automated peritoneal dialysis (APD): A simulation study . Clin Nephrol. 2018 Nov;90(5):334-340. doi: 10.5414/CN109471.
PubMed 30106369
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Telemonitoring on Compliance and Outcomes of Patients Undergoing Automated Peritoneal Dialysis With SHARESOURCE
- ClinicalTrials.gov ID
- NCT04157764
- Acronym / sponsor ID
- EMRP108057
- Conditions
- Compliance, Patient
- Keywords
- Telehealth, automated peritoneal dialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 8 Nov 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.
This study is to investigate the non-compliance rate of patients undergoing automated peritoneal dialysis by using automated peritoneal dialysis with SHARESOURCE software, and to evaluate if telemonitoring can improve peritoneal dialysis compliance and outcomes in the observation period.
Detailed description
The non-compliance of patients receiving automated peritoneal dialysis (APD) is around 10-20%, and was believed to be under-estimated. Recently, a two-way telehealth system, SHARESOURCE software, provide practitioners real-time monitoring and recording of the therapy of APD.
By using this APD with SHARESOURCE software, we want to investigate the non-compliance rate of patients undergoing automated peritoneal dialysis, want to see if it can improve peritoneal dialysis compliance and outcomes in the observation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- use automated peritoneal dialysis machine without SHARESOURCE for 12 weeks, then use automated peritoneal dialysis machine with SHARESOURCE for 12 weeks
| Arm | Type | Receives |
|---|---|---|
| APD | Experimental | Device: HomeChoice Claria APD machine with SHARESOURCE |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- stable received peritoneal dialysis for over 1 year. Use automated peritoneal dialysis machine regularly by him/herself.
Key exclusion criteria (3 listed)
- Acute hospitalization events due to acute coronary syndrome, stroke, heart failure, liver cirrhosis, systemic infection in 1 month.
- Life expectancy <1 year
- Peritoneal dialysis prescriptions will be scheduled or expected to change in 3 months
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 |
|---|---|---|
| HomeChoice Claria APD machine with SHARESOURCEHomeChoice Claria APD machine with SHARESOURCE software. SHARESOURCE is a software can telemonitor patients' compliance | Device | APD |
Primary outcome
Change of baseline patients' non-compliance rate at 3 months
Time frame: baseline(between week 0 and 12) and 3 months(week 12 and week 24)
Non compliance rate was calculated by the days of non-compliance divided by days of APD therapy
6 secondary outcomes
Change of baseline peritoneal dialysis adequacy at 3 and 6 months
Time frame: baseline, week 12 and week 24
Change of baseline uremic toxin level at 3 and 6 months
Time frame: baseline, week 12 and week 24
change of body composition analysis
Time frame: baseline, week 12 and week 24
peritonitis rate (patient-month)
Time frame: follow up to week 60
Hospitalization rate
Time frame: follow up to week 60
Change of telephone contact frequency
Time frame: baseline(between week 0 and 12) and 3 months(week 12 and week 24)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Background: PubMed 30798791Saran R, Robinson B, Abbott KC, Agodoa LYC, Bragg-Gresham J, Balkrishnan R, Bhave N, Dietrich X, Ding Z, Eggers PW, Gaipov A, Gillen D, Gipson D, Gu H, Guro P, Haggerty D, Han Y, He K, Herman W, Heung M, Hirth RA, Hsiung JT, Hutton D, Inoue A, Jacobsen SJ, Jin Y, Kalantar-Zadeh K, Kapke A, Kleine CE, Kovesdy CP, Krueter W, Kurtz V, Li Y, Liu S, Marroquin MV, McCullough K, Molnar MZ, Modi Z, Montez-Rath M, Moradi H, Morgenstern H, Mukhopadhyay P, Nallamothu B, Nguyen DV, Norris KC, O'Hare AM, Obi Y, Park C, Pearson J, Pisoni R, Potukuchi PK, Repeck K, Rhee CM, Schaubel DE, Schrager J, Selewski DT, Shamraj R, Shaw SF, Shi JM, Shieu M, Sim JJ, Soohoo M, Steffick D, Streja E, Sumida K, Kurella Tamura M, Tilea A, Turf M, Wang D, Weng W, Woodside KJ, Wyncott A, Xiang J, Xin X, Yin M, You AS, Zhang X, Zhou H, Shahinian V. US Renal Data System 2018 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2019 Mar;73(3 Suppl 1):A7-A8. doi: 10.1053/j.ajkd.2019.01.001. Epub 2019 Feb 21. No abstract available.
- Background: PubMed 9428459Bernardini J, Piraino B. Compliance in CAPD and CCPD patients as measured by supply inventories during home visits. Am J Kidney Dis. 1998 Jan;31(1):101-7. doi: 10.1053/ajkd.1998.v31.pm9428459.
- Background: PubMed 9259694The USRDS Dialysis Morbidity and Mortality Study: Wave 2. United States Renal Data System. Am J Kidney Dis. 1997 Aug;30(2 Suppl 1):S67-85. No abstract available.
- Background: PubMed 29694954Milan Manani S, Crepaldi C, Giuliani A, Virzi GM, Garzotto F, Riello C, de Cal M, Rosner MH, Ronco C. Remote Monitoring of Automated Peritoneal Dialysis Improves Personalization of Dialytic Prescription and Patient's Independence. Blood Purif. 2018;46(2):111-117. doi: 10.1159/000487703. Epub 2018 Apr 25.
- Background: PubMed 30106369Uchiyama K, Washida N, Yube N, Kasai T, Shinozuka K, Morimoto K, Hishikawa A, Inoue H, Urai H, Hagiwara A, Fujii K, Wakino S, Deenitchina S, Itoh H. The impact of a remote monitoring system of healthcare resource consumption in patients on automated peritoneal dialysis (APD): A simulation study . Clin Nephrol. 2018 Nov;90(5):334-340. doi: 10.5414/CN109471.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing HomeChoice Claria APD machine with SHARESOURCE in people with Compliance, Patient, run by E-DA Hospital.
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: status not confirmed, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shih-Yuan Hung (+8867-615-0011 ext. 2980, ed100367@edah.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of baseline patients' non-compliance rate at 3 months (time frame: baseline(between week 0 and 12) and 3 months(week 12 and week 24)). 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 NCT04157764, which also lists 5 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 19 Nov 2019.