Hemodialysis, HomeNCT02128347
Effectiveness of an Online Portal for Delivery of Care to Home Dialysis Patients
A study testing Electronic Patient Portal in people with Hemodialysis, Home and Peritoneal Dialysis, run by Karthik Tennankore at 1 site in Canada.
Trial summary
Home dialysis has many potential benefits compared to in-center hemodialysis including improved quality of life, reduced hospital admission and reduced cost. However, some patients perceive that home modalities are associated with increased isolation from the healthcare system, substandard care or higher risk of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Home, Peritoneal Dialysis
- What is being tested?
- Electronic Patient Portal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Feb 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
- Prevalent (>=3 months) home dialysis patients (peritoneal dialysis or home hemodialysis)
Who cannot join
- Does not provide consent
- On home dialysis for less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Home dialysis has many potential benefits compared to in-center hemodialysis including improved quality of life, reduced hospital admission and reduced cost. However, some patients perceive that home modalities are associated with increased isolation from the healthcare system, substandard care or higher risk of catastrophic events. Providing better support for home dialysis patients may enhance their ability to maintain at home, improve their health outcomes, increase quality of life and improve satisfaction with care. In other chronic disease populations a secure, online communication portal between physicians and patients has proven useful in enhancing care for patients. Thus far, the utility of an online portal communication system has not been tested in a cohort of home dialysis patients. The investigators hypothesize that this novel form of communication will improve care and outcomes for home dialysis patients. Therefore, in a cohort of home dialysis patients, the purposes of this study are as follows: 1) Does an online patient-portal improve patient satisfaction with home dialysis care? 2) Does an online patient-portal improve quality of life? 3) Does an online patient-portal reduce hospitalization and health service utilization?
Read the detailed description
Home dialysis (including peritoneal dialysis and home hemodialysis) has a number of potential benefits over in-center hemodialysis (including lower healthcare costs and improved quality of life for patients). However, overall quality of life remains low compared to the general population. Furthermore, home dialysis patients (primarily those on peritoneal dialysis) continue to experience a high rate of hospitalization. Finally, there can be improvement in patient satisfaction with home dialysis, particularly in the areas of shared decision making and handling of patient requests.
Regarding satisfaction with care, peritoneal dialysis patients have identified that "attentiveness to concerns", and clarity of recommendations is important. Improved satisfaction in turn, may be associated with improvements in quality of life. Therefore, identifying novel communication systems for home dialysis patients is crucial. The use of eHealth online portals that support online communication between patients and healthcare workers is increasing. An interface that allows patients to discuss treatment plans and address clinical problems while obviating the need for telephone communication has been shown to be beneficial in some studies. Such a system may improve patient satisfaction, reduce health service utilization, and potentially improve health outcomes.
Thus far, the feasibility and potential benefit of an eHealth online portal to facilitate communication has not been evaluated in home dialysis. Therefore, in a cohort of home dialysis patients, the purpose of this study is to identify the following: 1) Does an online portal improve patient satisfaction with home dialysis care? 2) Does an online portal improve quality of life? 3) Does an online portal reduce hospitalization and health service utilization? Overall, we hope that this study will inform the need to pursue a larger, multicenter trial to more rigorously evaluate the utility of this novel form of communication for home dialysis patients.
We will conduct a prospective pilot study of prevalent (receiving home dialysis for at least three months) home dialysis patients (including both peritoneal dialysis and home hemodialysis) at Capital Health. Consecutive patients that are evaluated in the home dialysis clinic over a 4-month period will be enrolled in the study if they provide consent.
- Conditions
- Hemodialysis, Home, Peritoneal Dialysis
- Being tested
- Electronic Patient Portal
- Keywords
- Hemodialysis, Home, Peritoneal Dialysis, Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Patient PortalOther
RelayHealth is a web-based application that allows patients and clinicians to communicate through a secure, password protected online electronic portal with data transfer capabilities. The system allows physicians and nurses to view patient questions, patient data and transmit messages to patients in response to questions or after clinic visits in an electronic message. In addition, patients can be made aware of upcoming investigations or clinic visits. Patients can also use the interface to identify any proposed changes (which would minimize recall mistakes after clinic visits) and submit queries pertaining to dialysis. Both patients and clinicians are made aware of new messages through email prompt, which moderates the asynchronous nature of electronic communication. Telephone communication can be maintained, but reserved for more urgent issues that require immediate assistance.
| Study group | Role | What they receive |
|---|---|---|
| Electronic Patient Portal | Other | RelayHealth is a web-based application that allows patients and healthcare workers to communicate through a secure, password protected online portal with data transfer capabilities. Effectiveness of the portal in improving several health outcomes from baseline-12 months will be assessed in this study. Receives: Other: Electronic Patient Portal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Satisfaction
Patient satisfaction will be examined in all patients at 0, 6 and 12 months using the Consumer Quality index (CQI) instrument (van der Veer SN, Jager KJ, Visserman E, Beekman RJ, Boeschoten EW, de Keizer NF, Heuveling L, Stronks K, Arah OA. Development and validation of the Consumer Quality index instrument to measure the experience and priority of chronic dialysis patients. Nephrol Dial Transplant. 2012 Aug;27(8):3284-91. This Dutch-language tool will be translated to English using a validated translation procedure.
Measured: 12 months
Secondary outcomes (2)
Change in Quality of Life
Patient quality of life will be measured in all patients at 0, 6 and 12 months after initiating the study. Specifically, change from baseline in the EuroQol-5D will be evaluated at 6 and 12 months after initiation of the patient portal.
Measured: 12 Months
Hospitalization and Health-Care Utilization Rates
Healthcare service utilization will consist of number and duration of hospitalizations, number of emergency room visits (for both dialysis and non-dialysis related complaints), number of non-advised drop-in visits to the home dialysis unit and number/duration and type of telephone contacts with the home dialysis unit. All utilization measures will be retrospectively assessed over the preceding three to twelve months (depending on available data) to get a baseline rate.
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 posted1 May 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2016
- Study completionFeb 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 Hemodialysis, HomeStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karthik Tennankore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karthik Tennankore, Nova Scotia Health Authority
- Investigators
- Karthik K Tennankore, MD, Principal investigator, Capital District Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02128347
- Sponsor's protocol ID
- eportal 2014-316
- Status last verified
- Jul 2016
- First submitted
- 29 Apr 2014
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kiberd J, Khan U, Stockman C, Radhakrishnan A, Phillips M, Kiberd BA, West KA, Soroka S, Chan C, Tennankore KK. Effectiveness of a Web-Based eHealth Portal for Delivery of Care to Home Dialysis Patients: A Single-Arm Pilot Study. Can J Kidney Health Dis. 2018 Sep 7;5:2054358118794415. doi: 10.1177/2054358118794415. eCollection 2018.
PubMed 30210802
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Online Portal for Delivery of Care to Home Dialysis Patients
- ClinicalTrials.gov ID
- NCT02128347
- Acronym / sponsor ID
- eportal 2014-316
- Conditions
- Hemodialysis, Home, Peritoneal Dialysis
- Keywords
- Hemodialysis, Home, Peritoneal Dialysis, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Karthik TennankoreUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 1 May 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.
Home dialysis has many potential benefits compared to in-center hemodialysis including improved quality of life, reduced hospital admission and reduced cost. However, some patients perceive that home modalities are associated with increased isolation from the healthcare system, substandard care or higher risk of catastrophic events. Providing better support for home dialysis patients may enhance their ability to maintain at home, improve their health outcomes, increase quality of life and improve satisfaction with care. In other chronic disease populations a secure, online communication portal between physicians and patients has proven useful in enhancing care for patients. Thus far, the utility of an online portal communication system has not been tested in a cohort of home dialysis patients. The investigators hypothesize that this novel form of communication will improve care and outcomes for home dialysis patients. Therefore, in a cohort of home dialysis patients, the purposes of this study are as follows: 1) Does an online patient-portal improve patient satisfaction with home dialysis care? 2) Does an online patient-portal improve quality of life? 3) Does an online patient-portal reduce hospitalization and health service utilization?
Detailed description
Home dialysis (including peritoneal dialysis and home hemodialysis) has a number of potential benefits over in-center hemodialysis (including lower healthcare costs and improved quality of life for patients). However, overall quality of life remains low compared to the general population. Furthermore, home dialysis patients (primarily those on peritoneal dialysis) continue to experience a high rate of hospitalization. Finally, there can be improvement in patient satisfaction with home dialysis, particularly in the areas of shared decision making and handling of patient requests.
Regarding satisfaction with care, peritoneal dialysis patients have identified that "attentiveness to concerns", and clarity of recommendations is important. Improved satisfaction in turn, may be associated with improvements in quality of life. Therefore, identifying novel communication systems for home dialysis patients is crucial. The use of eHealth online portals that support online communication between patients and healthcare workers is increasing. An interface that allows patients to discuss treatment plans and address clinical problems while obviating the need for telephone communication has been shown to be beneficial in some studies. Such a system may improve patient satisfaction, reduce health service utilization, and potentially improve health outcomes.
Thus far, the feasibility and potential benefit of an eHealth online portal to facilitate communication has not been evaluated in home dialysis. Therefore, in a cohort of home dialysis patients, the purpose of this study is to identify the following: 1) Does an online portal improve patient satisfaction with home dialysis care? 2) Does an online portal improve quality of life? 3) Does an online portal reduce hospitalization and health service utilization? Overall, we hope that this study will inform the need to pursue a larger, multicenter trial to more rigorously evaluate the utility of this novel form of communication for home dialysis patients.
We will conduct a prospective pilot study of prevalent (receiving home dialysis for at least three months) home dialysis patients (including both peritoneal dialysis and home hemodialysis) at Capital Health. Consecutive patients that are evaluated in the home dialysis clinic over a 4-month period will be enrolled in the study if they provide consent.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electronic Patient Portal | Other | Other: Electronic Patient PortalRelayHealth is a web-based application that allows patients and healthcare workers to communicate through a secure, password protected online portal with data transfer capabilities. Effectiveness of the portal in improving several health outcomes from baseline-12 months will be assessed in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prevalent (>=3 months) home dialysis patients (peritoneal dialysis or home hemodialysis)
Key exclusion criteria (2 listed)
- Does not provide consent
- On home dialysis for less than 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 |
|---|---|---|
| Electronic Patient PortalRelayHealth is a web-based application that allows patients and clinicians to communicate through a secure, password protected online electronic portal with data transfer capabilities. The system allows physicians and nurses to view patient questions, patient data and transmit messages to patients in response to questions or after clinic visits in an electronic message. In addition, patients can be made aware of upcoming investigations or clinic visits. Patients can also use the interface to identify any proposed changes (which would minimize recall mistakes after clinic visits) and submit queries pertaining to dialysis. Both patients and clinicians are made aware of new messages through email prompt, which moderates the asynchronous nature of electronic communication. Telephone communication can be maintained, but reserved for more urgent issues that require immediate assistance. | Other | Electronic Patient Portal |
Primary outcome
Change in Patient Satisfaction
Time frame: 12 months
Patient satisfaction will be examined in all patients at 0, 6 and 12 months using the Consumer Quality index (CQI) instrument (van der Veer SN, Jager KJ, Visserman E, Beekman RJ, Boeschoten EW, de Keizer NF, Heuveling L, Stronks K, Arah OA. Development and validation of the Consumer Quality index instrument to measure the experience and priority of chronic dialysis patients. Nephrol Dial Transplant. 2012 Aug;27(8):3284-91. This Dutch-language tool will be translated to English using a validated translation procedure.
2 secondary outcomes
Change in Quality of Life
Time frame: 12 Months
Hospitalization and Health-Care Utilization Rates
Time frame: 12 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 26 Jul 2016.
- Derived from this study: PubMed 30210802Kiberd J, Khan U, Stockman C, Radhakrishnan A, Phillips M, Kiberd BA, West KA, Soroka S, Chan C, Tennankore KK. Effectiveness of a Web-Based eHealth Portal for Delivery of Care to Home Dialysis Patients: A Single-Arm Pilot Study. Can J Kidney Health Dis. 2018 Sep 7;5:2054358118794415. doi: 10.1177/2054358118794415. eCollection 2018.
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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.
Karthik K Tennankore, MD principal investigator
Capital District 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 Electronic Patient Portal in people with Hemodialysis, Home and Peritoneal Dialysis, run by Karthik Tennankore at 1 site 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 1 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 26 Jul 2016. 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 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?
Change in Patient Satisfaction (time frame: 12 months). 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 NCT02128347, 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 26 Jul 2016.