End Stage Renal DiseaseVirtual WardNCT01912001
Virtual Ward for Home Dialysis
A study testing Telephone follow-up and Sympton Assessment in people with End Stage Renal Disease and Kidney Failure, run by Christopher Chan at 7 sites in Canada.
Trial summary
Home based renal replacement therapy (RRT), including peritoneal dialysis (PD) and home hemodialysis(HHD), offers enhanced quality of life and clinical advantages compared to conventional in-center hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Kidney Failure, Home Dialysis
- What is being tested?
- Telephone follow-up and Sympton Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 7 sitesCanada
- Study dates
- Sep 2013to Mar 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
- Patient in the home dialysis program (PD and HHD)and on of the following:
- Discharge from hospital following an inpatient admissions
- Medical procedure (e.g. vascular access procedure).
- Treatment with antibiotics.
- Completion of home dialysis training program.
Who cannot join
- Decline consent.
- Unable to participate - (e.g. no phone at home, language barrier)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
University of Alberta
Edmonton, Alberta, T6G 2V2
Capital District Health Authority
Halifax, Nova Scotia, B3H 1V7
The Ottawa Hospital
Ottawa, Ontario, K1H 1A2
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
University Health Network
Toronto, Ontario, M5G 2C4
Vancouver General Hospital
Vancouver, British Columbia, V6H 0A5
About this study
Official title: Virtual Ward for Home Dialysis - A Novel Model to Address Transitions of Care
Home based renal replacement therapy (RRT), including peritoneal dialysis (PD) and home hemodialysis(HHD), offers enhanced quality of life and clinical advantages compared to conventional in-center hemodialysis. Patients with end stage renal disease, that is failure of the kidneys such that dialysis is required, are at high risk for adverse health events especially during a period of transition following a change in care settings. The investigators aim to implement a Home Dialysis Virtual Ward (HDVW) strategy of telephone follow-up, which is targeted to minimize gaps of care during transitions in care.
The investigators aim to have clinicians follow patients by telephone if they meet one of the following four criteria;
Read more
- Discharge from hospital.
- Having an interventional procedure.
- Prescription of an antibiotic.
- Completion of Home Dialysis training.
The major goal of this HDVW initiative is to provide appropriate and effective supports to medically complex patients in a targeted window of vulnerability.
Read the detailed description
End stage renal disease (ESRD) is kidney disease that requires dialysis or kidney transplant to replace lost kidney function. The most common renal replacement therapy in North America is conventional, in-center hemodialysis (CHD). Home dialysis - including peritoneal dialysis (PD) and home hemodialysis(HHD)offers benefits to quality of life, patient satisfaction and clinical advantages, including better survival compared to CHD. (references 1-11 in the protocol).
Patients with (ESRD) have a high burden of co-morbidity. Periods of transition of care from acute care to other settings are thought to represent times of increased vulnerability. Since patients who require home dialysis have high co-morbidity and have complex medical care issues, the investigators seek to improve transitions of care for these patients with a novel strategy of follow-up.
When patients have been hospitalized, had treatment for an infection, had a procedure, or have just transitioned to home dialysis therapy,the investigators aim to decrease gaps in care by having a clinician follow-up by telephone with these patients in a scheduled way.
During the telephone call the clinician will assess the patients care and symptoms, and make adjustments to prescriptions of medications and dialysis, or referrals to additional care as required. Evaluation of care will include:
- Indication for admission to the Virtual Ward.
- Dialysis prescription.
- Demographic and comorbidity data.
- Medication reconciliation.
- Symptom Assessment.
- Dietary review.
Symptoms will be evaluated using a standardized patient assessment tool,the Charlson Comorbidity Index and the modified Edmonton Symptom Assessment Scale.
At the end of the Virtual Ward follow-up period, patients will be asked to complete a Patient Satisfaction Questionnaire.
Data from a preliminary vanguard pilot phase of 84 assessments done in 21 patients over 2 months indicates that 170 to 200 patients recruited from eight sites during a 10 month period should be sufficient to allow analysis of the data collected.
Each of the participating Investigator's will have input into the study conduct and publication preparation.
- Conditions
- End Stage Renal Disease, Kidney Failure, Home Dialysis
- Being tested
- Telephone follow-up, Sympton Assessment
- Keywords
- end stage renal disease, kidney failure, home dialysis, hemodialysis, peritoneal dialysis, gaps in care, co-morbidity, transitions of care settings
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone follow-upOther
Sympton AssessmentOther
| Study group | Role | What they receive |
|---|---|---|
| Telephone follow-up. | Other | A member of the Home Dialysis team will telephone patients to follow-up on their symptoms, dialysis and care. Receives: Other: Telephone follow-up; Other: Sympton Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of care gaps identified.
Measured: Up to 24 weeks post discharge from the virtual ward.
Secondary outcomes (8)
Dialysis prescription and adherence.
Orders for dialysis treatment and amount of dialysis performed will be recorded.
Measured: Up to 24 weeks.
Morbidity associated with dialysis therapy.
All deaths will be recorded.
Measured: Up to 24 weeks post discharge from the virtual ward.
Burden associated with travel time for patients.
Travel time for health related visits will be recorded.
Measured: Up to 24 weeks post discharge from the virtual ward.
Medication reconciliation.
Best possible medication history will be recorded at each interaction.
Measured: Up to 24 weeks post discharge from the virtual ward.
Symptom management.
Symptom assessment will be done at each interaction.
Measured: Up to 24 weeks post discharge from the virtual ward.
Adherence with dietary recommendations.
Diet review will be performed at each visit.
Measured: Up to 24 weeks post discharge from the virtual ward.
Coordination of care among participating providers.
Referrals and consultations will be tracked.
Measured: During virtual ward follow-up.
Patient satisfaction.
A satisfaction questionnaire will be mailed to participants at the end of participation.
Measured: 24 weeks post discharge from the virtual ward.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Chan
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Vancouver General Hospital, Sunnybrook Health Sciences Centre, St. Paul's Hospital, Canada, University of Alberta, Unity Health Toronto, The Ottawa Hospital, Capital Health Nova Scotia
- Responsible party
- Sponsor-investigator, Christopher Chan, University Health Network, Toronto
- Investigators
- Christopher T Chan, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912001
- Sponsor's protocol ID
- 12-5397-AE
- Acronym
- Virtual Ward
- Status last verified
- May 2016
- First submitted
- 22 Jul 2013
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Schachter ME, Bargman JM, Copland M, Hladunewich M, Tennankore KK, Levin A, Oliver M, Pauly RP, Perl J, Zimmerman D, Chan CT. Rationale for a home dialysis virtual ward: design and implementation. BMC Nephrol. 2014 Feb 14;15:33. doi: 10.1186/1471-2369-15-33.
PubMed 24528505
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Ward for Home Dialysis - A Novel Model to Address Transitions of Care
- ClinicalTrials.gov ID
- NCT01912001
- Acronym / sponsor ID
- Virtual Ward / 12-5397-AE
- Conditions
- End Stage Renal Disease, Kidney Failure, Home Dialysis
- Keywords
- end stage renal disease, kidney failure, home dialysis, hemodialysis, peritoneal dialysis, gaps in care, co-morbidity, transitions of care settings
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Christopher ChanUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation, Vancouver General Hospital, Sunnybrook Health Sciences Centre, St. Paul's Hospital, Canada, University of Alberta, Unity Health Toronto, The Ottawa Hospital, Capital Health Nova Scotia
- Study start
- Sep 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Jul 2013 (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.
Home based renal replacement therapy (RRT), including peritoneal dialysis (PD) and home hemodialysis(HHD), offers enhanced quality of life and clinical advantages compared to conventional in-center hemodialysis. Patients with end stage renal disease, that is failure of the kidneys such that dialysis is required, are at high risk for adverse health events especially during a period of transition following a change in care settings. The investigators aim to implement a Home Dialysis Virtual Ward (HDVW) strategy of telephone follow-up, which is targeted to minimize gaps of care during transitions in care.
The investigators aim to have clinicians follow patients by telephone if they meet one of the following four criteria;
- Discharge from hospital.
- Having an interventional procedure.
- Prescription of an antibiotic.
- Completion of Home Dialysis training.
The major goal of this HDVW initiative is to provide appropriate and effective supports to medically complex patients in a targeted window of vulnerability.
Detailed description
End stage renal disease (ESRD) is kidney disease that requires dialysis or kidney transplant to replace lost kidney function. The most common renal replacement therapy in North America is conventional, in-center hemodialysis (CHD). Home dialysis - including peritoneal dialysis (PD) and home hemodialysis(HHD)offers benefits to quality of life, patient satisfaction and clinical advantages, including better survival compared to CHD. (references 1-11 in the protocol).
Patients with (ESRD) have a high burden of co-morbidity. Periods of transition of care from acute care to other settings are thought to represent times of increased vulnerability. Since patients who require home dialysis have high co-morbidity and have complex medical care issues, the investigators seek to improve transitions of care for these patients with a novel strategy of follow-up.
When patients have been hospitalized, had treatment for an infection, had a procedure, or have just transitioned to home dialysis therapy,the investigators aim to decrease gaps in care by having a clinician follow-up by telephone with these patients in a scheduled way.
During the telephone call the clinician will assess the patients care and symptoms, and make adjustments to prescriptions of medications and dialysis, or referrals to additional care as required. Evaluation of care will include:
- Indication for admission to the Virtual Ward.
- Dialysis prescription.
- Demographic and comorbidity data.
- Medication reconciliation.
- Symptom Assessment.
- Dietary review.
Symptoms will be evaluated using a standardized patient assessment tool,the Charlson Comorbidity Index and the modified Edmonton Symptom Assessment Scale.
At the end of the Virtual Ward follow-up period, patients will be asked to complete a Patient Satisfaction Questionnaire.
Data from a preliminary vanguard pilot phase of 84 assessments done in 21 patients over 2 months indicates that 170 to 200 patients recruited from eight sites during a 10 month period should be sufficient to allow analysis of the data collected.
Each of the participating Investigator's will have input into the study conduct and publication preparation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telephone follow-up. | Other | Other: Telephone follow-up, Other: Sympton AssessmentA member of the Home Dialysis team will telephone patients to follow-up on their symptoms, dialysis and care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient in the home dialysis program (PD and HHD)and on of the following:
- Discharge from hospital following an inpatient admissions
- Medical procedure (e.g. vascular access procedure).
- Treatment with antibiotics.
- Completion of home dialysis training program.
Key exclusion criteria (2 listed)
- Decline consent.
- Unable to participate - (e.g. no phone at home, language barrier)
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 |
|---|---|---|
| Telephone follow-up | Other | Telephone follow-up. |
| Sympton Assessment | Other | Telephone follow-up. |
Primary outcome
The number of care gaps identified.
Time frame: Up to 24 weeks post discharge from the virtual ward.
8 secondary outcomes
Dialysis prescription and adherence.
Time frame: Up to 24 weeks.
Morbidity associated with dialysis therapy.
Time frame: Up to 24 weeks post discharge from the virtual ward.
Burden associated with travel time for patients.
Time frame: Up to 24 weeks post discharge from the virtual ward.
Medication reconciliation.
Time frame: Up to 24 weeks post discharge from the virtual ward.
Symptom management.
Time frame: Up to 24 weeks post discharge from the virtual ward.
Adherence with dietary recommendations.
Time frame: Up to 24 weeks post discharge from the virtual ward.
Coordination of care among participating providers.
Time frame: During virtual ward follow-up.
Patient satisfaction.
Time frame: 24 weeks post discharge from the virtual ward.
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 12 May 2016.
- Derived from this study: PubMed 24528505Schachter ME, Bargman JM, Copland M, Hladunewich M, Tennankore KK, Levin A, Oliver M, Pauly RP, Perl J, Zimmerman D, Chan CT. Rationale for a home dialysis virtual ward: design and implementation. BMC Nephrol. 2014 Feb 14;15:33. doi: 10.1186/1471-2369-15-33.
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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.
Christopher T Chan, MD principal investigator
University Health Network, Toronto
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone follow-up and Sympton Assessment in people with End Stage Renal Disease and Kidney Failure, run by Christopher Chan at 7 sites in Canada.
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 5 inclusion and 2 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. 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?
The number of care gaps identified. (time frame: Up to 24 weeks post discharge from the virtual ward.). 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 NCT01912001, which also lists 1 linked publication.
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 12 May 2016.