Improving Adherence in Renal Dialysis Patients Through Electronic Interventions

NCT02970201 | Completed

• 1 other identifier: 201412068
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Endstage Renal Disease

Keywords

eHealth; mHealth; Hemodialysis; Adherence; Electronic intervention; ESRD; Nephrology

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks

Secondary Outcomes (1)

• Hospitalization

  16 weeks

Study Arms (2)

Period I EpxDialysis (SMS Messaging)

OTHER

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

Other: EpxDialysis

Period II EpxDialysis (Control)

OTHER

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

Other: EpxDialysis

Interventions

EpxDialysis OTHER

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.

Period I EpxDialysis (SMS Messaging); Period II EpxDialysis (Control)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine - Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (8)

• 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)

  BACKGROUND

• Lamping, D. L. & Campbell, K. A. Hemodialysis Compliance: Assessment, Prediction, and Intervention: Part I. Seminars in dialysis 3, 52-56 (1990).

  BACKGROUND

• 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.

  PMID: 7985669 BACKGROUND

• Lamping, D. L. & Campbell, K. A. Hemodialysis Compliance: Assessment, Prediction, and Intervention: Part II. Seminars in dialysis 3, (1990).

  BACKGROUND

• 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.

  PMID: 7288877 BACKGROUND

• 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.

  PMID: 20569761 BACKGROUND

• 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.

  PMID: 23557331 BACKGROUND

• 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.

  PMID: 8235736 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Will R Ross, MD, MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 21, 2016
• Study Start: February 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2016
• Last Updated: May 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)