search
Back to results

Improving Adherence in Renal Dialysis Patients Through Electronic Interventions

Primary Purpose

Endstage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EpxDialysis
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endstage Renal Disease focused on measuring eHealth, mHealth, Hemodialysis, Adherence, Electronic intervention, ESRD, Nephrology

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All potential subjects are between 18 and 75 years of age, and have been receiving hemodialysis treatments, scheduled for 3 sessions/week, for at least 8 weeks at the Chromalloy American Kidney Center or Washington University Dialysis Center.
  • The individuals will be prospectively identified as whether they have a history of occasional non-attendance to dialysis treatments, defined as 2-3 missed appointments in the preceding 8 week period or 24 scheduled sessions. These subjects will be enrolled as part of one cohort. Individuals who have frequent non-attendance, defined as 4-6 missed appointments in the preceding 8 week period or 24 scheduled sessions, will be enrolled as a second cohort.
  • Subjects must be able to provide a phone number at which they can either receive SMS text messages and/or phone calls. The cost of messages will be paid for by the sender. Subjects must be able and willing to provide consent and authorize access of their medical record and dialysis clinic record for study use.

Exclusion Criteria:

  • Persons not receiving ongoing hemodialysis treatments or new patients with less than 8 weeks of treatments at the dialysis center.
  • Persons not intended to receive 3 dialysis treatments/week for the next 8 weeks.
  • Pregnant individuals.
  • Persons unable to be contacted by phone call or SMS text message, or unwilling to provide their contact number.
  • Persons unwilling to consent and follow the assigned regimen and complete the required follow up.
  • Persons with severe neurological or cognitive disorders, limiting their ability to provide consent.

Sites / Locations

  • Washington University School of Medicine - Barnes Jewish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Period I EpxDialysis (SMS Messaging)

Period II EpxDialysis (Control)

Arm Description

SMS Messaging arm receives the intervention (EpxDialysis) first, then resumes standard of care at crossover (8 weeks).

Control arm receives standard of care first, then receives the intervention (EpxDialysis) at crossover.

Outcomes

Primary Outcome Measures

Dialysis appointment attendance
The primary objective of this prospective randomized control study is to assess the effects of an electronic intervention, which sends automated SMS text messages or pre-recorded phone messages, on attendance rate to dialysis sessions among non-adherent dialysis patients.

Secondary Outcome Measures

Hospitalization
Compare the number of emergency department visits and hospitalizations between groups during intervention and control phases

Full Information

First Posted
November 17, 2016
Last Updated
May 9, 2018
Sponsor
Washington University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT02970201
Brief Title
Improving Adherence in Renal Dialysis Patients Through Electronic Interventions
Official Title
Improving Adherence in Renal Dialysis Patients; a Randomized Crossover Trial for an Electronic Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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 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 SMS text messaging to phone call recordings to notify patients prior to each of their upcoming appointment times, with the option of also alerting 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. This intervention may potentially improve patient adherence with scheduled sessions, increase patient satisfaction with their treatment and prevent medical complications associated with missing dialysis. 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 session attendance among patients with a history of poor attendance. Our secondary aim is to identify factors that may be barriers to dialysis appointment attendance and are associated with emergency department (ED) or hospital utilization. Procedures: Dialysis patients of the Chromalloy American Kidney Center (CAKC) at Barnes Jewish Hospital (BJH) and the Washington University Dialysis Center (WUDC) will be included in this study. Two cohorts will be prospectively identified, one group consisting of individuals with a history of occasional non-attendance to treatment sessions, defined as 2-3 missed sessions out of 24 consecutive sessions in the past 8 weeks; the other group consisting of individuals who are frequently non-adherent (4-6 missed sessions in the past 24 consecutive sessions). Patients from each cohort will be recruited and then randomized to either the experimental or the control group. Group A will receive the electronic intervention featuring automated SMS text message and/or phone call 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. At time of enrollment, all subjects will be asked to complete a questionnaire to determine the demographic characteristics of the study population of interest and identify possible socio-economic factors contributing to non-adherence to the prescribed 3 times weekly dialysis schedule. The 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 through BJH. Subjects will be asked to complete a post-questionnaire to rate their satisfaction with their current schedule of dialysis and their satisfaction with the electronic intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endstage Renal Disease
Keywords
eHealth, mHealth, Hemodialysis, Adherence, Electronic intervention, ESRD, Nephrology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Period I EpxDialysis (SMS Messaging)
Arm Type
Other
Arm Description
SMS Messaging arm receives the intervention (EpxDialysis) first, then resumes standard of care at crossover (8 weeks).
Arm Title
Period II EpxDialysis (Control)
Arm Type
Other
Arm Description
Control arm receives standard of care first, then receives the intervention (EpxDialysis) at crossover.
Intervention Type
Other
Intervention Name(s)
EpxDialysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dialysis appointment attendance
Description
The primary objective of this prospective randomized control study is to assess the effects of an electronic intervention, which sends automated SMS text messages or pre-recorded phone messages, on attendance rate to dialysis sessions among non-adherent dialysis patients.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Hospitalization
Description
Compare the number of emergency department visits and hospitalizations between groups during intervention and control phases
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All potential subjects are between 18 and 75 years of age, and have been receiving hemodialysis treatments, scheduled for 3 sessions/week, for at least 8 weeks at the Chromalloy American Kidney Center or Washington University Dialysis Center. The individuals will be prospectively identified as whether they have a history of occasional non-attendance to dialysis treatments, defined as 2-3 missed appointments in the preceding 8 week period or 24 scheduled sessions. These subjects will be enrolled as part of one cohort. Individuals who have frequent non-attendance, defined as 4-6 missed appointments in the preceding 8 week period or 24 scheduled sessions, will be enrolled as a second cohort. Subjects must be able to provide a phone number at which they can either receive SMS text messages and/or phone calls. The cost of messages will be paid for by the sender. Subjects must be able and willing to provide consent and authorize access of their medical record and dialysis clinic record for study use. Exclusion Criteria: Persons not receiving ongoing hemodialysis treatments or new patients with less than 8 weeks of treatments at the dialysis center. Persons not intended to receive 3 dialysis treatments/week for the next 8 weeks. Pregnant individuals. Persons unable to be contacted by phone call or SMS text message, or unwilling to provide their contact number. Persons unwilling to consent and follow the assigned regimen and complete the required follow up. Persons with severe neurological or cognitive disorders, limiting their ability to provide consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Will R Ross, MD, MPH
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine - Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
U.S. Renal Data System Annual Data Report. Chapter 1: Incidence, prevalence, patient characteristics and modality. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD https://www.usrds.org/2015/view/v2_01.aspx (2015)
Results Reference
background
Citation
Lamping, D. L. & Campbell, K. A. Hemodialysis Compliance: Assessment, Prediction, and Intervention: Part I. Seminars in dialysis 3, 52-56 (1990).
Results Reference
background
PubMed Identifier
7985669
Citation
Sherman RA, Cody RP, Matera JJ, Rogers ME, Solanchick JC. Deficiencies in delivered hemodialysis therapy due to missed and shortened treatments. Am J Kidney Dis. 1994 Dec;24(6):921-3. doi: 10.1016/s0272-6386(12)81061-4.
Results Reference
background
Citation
Lamping, D. L. & Campbell, K. A. Hemodialysis Compliance: Assessment, Prediction, and Intervention: Part II. Seminars in dialysis 3, (1990).
Results Reference
background
PubMed Identifier
7288877
Citation
Cummings KM, Becker MH, Kirscht JP, Levin NW. Intervention strategies to improve compliance with medical regimens by ambulatory hemodialysis patients. J Behav Med. 1981 Mar;4(1):111-27. doi: 10.1007/BF00844851.
Results Reference
background
PubMed Identifier
20569761
Citation
Parikh A, Gupta K, Wilson AC, Fields K, Cosgrove NM, Kostis JB. The effectiveness of outpatient appointment reminder systems in reducing no-show rates. Am J Med. 2010 Jun;123(6):542-8. doi: 10.1016/j.amjmed.2009.11.022.
Results Reference
background
PubMed Identifier
23557331
Citation
Junod Perron N, Dao MD, Righini NC, Humair JP, Broers B, Narring F, Haller DM, Gaspoz JM. Text-messaging versus telephone reminders to reduce missed appointments in an academic primary care clinic: a randomized controlled trial. BMC Health Serv Res. 2013 Apr 4;13:125. doi: 10.1186/1472-6963-13-125.
Results Reference
background
PubMed Identifier
8235736
Citation
Bame SI, Petersen N, Wray NP. Variation in hemodialysis patient compliance according to demographic characteristics. Soc Sci Med. 1993 Oct;37(8):1035-43. doi: 10.1016/0277-9536(93)90438-a.
Results Reference
background
Links:
URL
https://www.usrds.org/2015/view/v2_01.aspx
Description
U.S. Renal Data System Annual Data Report. Chapter 1: Incidence, prevalence, patient characteristics and modality. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD

Learn more about this trial

Improving Adherence in Renal Dialysis Patients Through Electronic Interventions

We'll reach out to this number within 24 hrs