CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
EpxDialysisother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02970201
NCT02970201N/ACompleted

Improving Adherence in Renal Dialysis Patients; a Randomized Crossover Trial for an Electronic Intervention

Washington University School of Medicine·interventional·Posted Nov 21, 2016·Updated May 11, 2018

In Brief

A clinical study evaluating EpxDialysis for Endstage Renal Disease. Completed, enrolled 26 participants across 1 site.

Detailed Summary

Dialysis treatment non-adherence is a prevalent problem among the end-stage renal population receiving chronic hemodialysis. The complications associated with missed or shortened dialysis sessions are serious and frequently require emergent medical care or hospitalization. Previous studies have shown that electronic messages have significantly improved attendance rates in a primary care setting, but these messages have not been validated in the chronic dialysis population. An electronic intervention has been developed by Epharmix, a WUSTL IDEA Labs (ideas.wustl.edu) team, which has the capacity to use automated SMS text messages and/or phone calls to notify patients prior to each upcoming appointment, as well as alert a designated patient advocate. Patients receiving the messages are provided with key contact information for a dialysis rescheduling phone line, transportation resources, social work services, etc. They may also receive instructions on what to do if they are experiencing physical symptoms and need educational facts about dialysis. In particular, the intervention is designed to demonstrate to patients that the center cares and is concerned for their health and wellbeing. This intervention may potentially improve patient adherence to their scheduled sessions, increase patient satisfaction with their treatment, and prevent medical complications associated with missed dialysis appointments. This study aims to determine whether an electronic intervention, which sends SMS text messages or phone calls of key dialysis treatment information, is able to improve dialysis treatment session attendance among dialysis patients with a history of poor attendance. We secondarily aim to identify the factors that may be barriers to dialysis treatment session attendance and the emergency department or hospital utilization associated with missed dialysis treatments. Patients will be prospectively identified, recruited, and randomized into two groups. Group A will receive the electronic intervention prior to their appointments; Group B will not receive any electronic intervention. After 8 weeks, crossover will occur for both groups and the study will continue for an additional 8 weeks. Participants' clinic records will be reviewed to determine the numbers of missed and attended appointments, as well as records of ED visits and hospital admissions. Subjects will be asked to complete a post-study satisfaction questionnaire.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 21, 2016
Enrollment StartFeb 1, 2015
Primary CompletionJun 1, 2015
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.6 years ago

Interventions

EpxDialysisother

The EpxDialysis intervention consists of automated SMS text or voice messages delivered to the patient's preferred phone number three times per week. These messages provide details about the subject's upcoming hemodialysis session, anticipatory guidance regarding clinically-concerning symptoms, as well as the option for direct call routing to the dialysis center for rescheduling sessions.