- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02128347
Effectiveness of an Online Portal for Delivery of Care to Home Dialysis Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 1V8
- Capital Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Prevalent (>=3 months) home dialysis patients (peritoneal dialysis or home hemodialysis)
Exclusion Criteria:
- Does not provide consent
- On home dialysis for less than 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Electronic Patient Portal
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Patient Satisfaction
Time Frame: 12 months
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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.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quality of Life
Time Frame: 12 Months
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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.
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12 Months
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Hospitalization and Health-Care Utilization Rates
Time Frame: 12 Months
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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.
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12 Months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of Portal
Time Frame: 12 months
|
A modified version of the Acceptability E scale (Tariman JD, Berry DL, Halpenny B, Wolpin S, Schepp K. Validation and testing of the Acceptability E-scale for web-based patient-reported outcomes in cancer care.
Appl Nurs Res.
2011 Feb;24(1):53-8) will be administered at 6 and 12 months in patients utilizing the portal, to assess their perception of the tool itself.
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12 months
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Patient Satisfaction with the Portal
Time Frame: 12 months
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A secondary patient satisfaction questionnaire (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) will be used to assess patient satisfaction with the portal.
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karthik K Tennankore, MD, Capital District Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- eportal 2014-316
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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