NCT02128347

Brief 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 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

1.3 years

First QC Date

April 29, 2014

Last Update Submit

July 25, 2016

Conditions

Keywords

Hemodialysis, HomePeritoneal DialysisTelemedicine

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (2)

  • Change in Quality of Life

    12 Months

  • Hospitalization and Health-Care Utilization Rates

    12 Months

Other Outcomes (2)

  • Acceptability of Portal

    12 months

  • Patient Satisfaction with the Portal

    12 months

Study Arms (1)

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.

Other: Electronic Patient Portal

Interventions

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.

Electronic Patient Portal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prevalent (\>=3 months) home dialysis patients (peritoneal dialysis or home hemodialysis)

You may not qualify if:

  • Does not provide consent
  • On home dialysis for less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Health

Halifax, Nova Scotia, B3H 1V8, Canada

Location

Related Publications (1)

  • 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.

Study Officials

  • Karthik K Tennankore, MD

    Capital District Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, Division of Nephrology, Department of Medicine

Study Record Dates

First Submitted

April 29, 2014

First Posted

May 1, 2014

Study Start

October 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations