Enhancing the Cardiovascular Safety of Hemodialysis Care (Dialysafe)

NCT03171545 | Completed Results DMC

• 2 other identifiers: HUM00125305IHS-1503-27848
• Study Type: interventional
• Target: 1,431
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is reduce episodes of intradialytic hypotension, low blood pressure during a hemodialysis session, in patients with End Stage Renal Disease (ESRD). Recruitment will take place on the clinic level rather than the patient level.

Conditions

Kidney Failure; End Stage Renal Disease; Hypotension; Cardiovascular Diseases; Patient Safety

Keywords

Peer Mentoring; Team Training; Checklist

Outcome Measures

Primary Outcomes (1)

• Dialysis Session Stability

  Systolic blood pressure (SBP) falling below 100 mmHg (using lowest SBP during session) if starting SBP ≥100.

  24 weeks

Secondary Outcomes (9)

• Fluid Adherence

  24 weeks

• Dialysis Adherence - Average Weekly Minutes Missed Over Intervention Period

  24 weeks

• Dialysis Adherence - Average Weekly Sessions Missed During Intervention Period

  24 weeks

• Patient Symptoms - Post-dialysis Recovery Time

  24 weeks

• Patient Symptoms - Symptom Burden

  24 weeks

Study Arms (4)

Patient Activation

EXPERIMENTAL

This arm focuses on patients. It includes peer mentoring by trained End Stage Renal Disease (ESRD) patients. Mentors will hold 5 multimedia-aided meetings with other patients that include motivational interviewing and role modeling.

Behavioral: Patient Activation

Provider Education

EXPERIMENTAL

This arm focuses on dialysis facility care teams. It includes team training, online education, and checklists.

Behavioral: Provider Education

No Intervention

NO INTERVENTION

Patients in clinic receive usual care.

Patient and Provider

EXPERIMENTAL

This arm includes both Patient Activation and Provider Education interventions

Behavioral: Patient Activation; Behavioral: Provider Education

Interventions

Patient Activation BEHAVIORAL

Patients in clinics assigned to this group will be offered peer mentoring and digital resources.

Patient Activation; Patient and Provider

Provider Education BEHAVIORAL

Staff in clinics assigned to this group will receive team training and a checklist.

Patient and Provider; Provider Education

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• outpatient hemodialysis facilities
• at least 70 adult (\>21 years old) patients to guarantee sample size

You may not qualify if:

• facilities involved in another study
• facilities in immediate jeopardy
• facilities with 1-star quality ratings
• facilities designated as COVID-19 isolation facilities
• individual patients who are currently incarcerated
• individual patients who have poor cognition or cognitive impairment
• individual patients unable to comprehend the patient information sheet due to lack of facility in English or Spanish
• individual patients who have opted out of data collection

Sponsors & Collaborators

• University of Michigan: lead
• University of California, Irvine: collaborator
• National Kidney Foundation, United States: collaborator
• Fresenius Medical Care North America: collaborator

Study Sites (1)

Fresenius Kidney Care University Of Michigan - Ann Arbor

Ann Arbor, Michigan, 48104, United States

Location

Related Publications (6)

• Veinot TC, Gillespie B, Argentina M, Bragg-Gresham J, Chatoth D, Collins Damron K, Heung M, Krein S, Wingard R, Zheng K, Saran R. Enhancing the Cardiovascular Safety of Hemodialysis Care Using Multimodal Provider Education and Patient Activation Interventions: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2023 Apr 20;12:e46187. doi: 10.2196/46187.

  PMID: 37079365 BACKGROUND

• Veinot TC, Clarke PJ, Romero DM, Buis LR, Dillahunt TR, Vydiswaran VVG, Beals A, Brown L, Richards O, Williamson A, Antonio MG. Equitable Research PRAXIS: A Framework for Health Informatics Methods. Yearb Med Inform. 2022 Aug;31(1):307-316. doi: 10.1055/s-0042-1742542. Epub 2022 Dec 4.

  PMID: 36463889 BACKGROUND

• Willis M, Brand Hein L, Hu Z, Saran R, Argentina M, Bragg-Gresham J, Krein SL, Gillespie B, Zheng K, Veinot TC. Usability Evaluation of a Tablet-Based Intervention to Prevent Intradialytic Hypotension in Dialysis Patients During In-Clinic Dialysis: Mixed Methods Study. JMIR Hum Factors. 2021 Jun 14;8(2):e26012. doi: 10.2196/26012.

  PMID: 34121664 BACKGROUND

• Willis MA, Hein LB, Hu Z, Saran R, Argentina M, Bragg-Gresham J, Krein SL, Gillespie B, Zheng K, Veinot TC. Feeling better on hemodialysis: user-centered design requirements for promoting patient involvement in the prevention of treatment complications. J Am Med Inform Assoc. 2021 Jul 30;28(8):1612-1631. doi: 10.1093/jamia/ocab033.

  PMID: 34117493 BACKGROUND

• Kuo PY, Saran R, Argentina M, Heung M, Bragg-Gresham J, Krein S, Gillespie BW, Zheng K, Veinot TC. Cramping, crashing, cannulating, and clotting: a qualitative study of patients' definitions of a "bad run" on hemodialysis. BMC Nephrol. 2020 Feb 27;21(1):67. doi: 10.1186/s12882-020-01726-8.

  PMID: 32103726 BACKGROUND

• Kuo PY, Saran R, Argentina M, Heung M, Bragg-Gresham JL, Chatoth D, Gillespie B, Krein S, Wingard R, Zheng K, Veinot TC. Development of a checklist for the prevention of intradialytic hypotension in hemodialysis care: Design considerations based on activity theory. In: Proceedings of the 2019 CHI Conference on Human Factors in Computing Systems 2019 May 2 (pp. 1-14).

  BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic; Hypotension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Results displayed for the primary and secondary outcomes are based on data from the 24-week intervention period, with the exception of quality of life measures based on the post-intervention quality of life survey conducted annually in each clinic.

Results Point of Contact

• Title: Dr. Tiffany Veinot
• Organization: University of Michigan

tveinot@umich.edu

734-615-8281

Study Officials

• Tiffany Veinot, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Joan C. Durrance Collegiate Professor

Model Details: The study is a 2X2 factorial design, such that five facilities will get the provider education only; five will get the patient activation intervention only; five will get both interventions; and five will get no interventions.

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: May 31, 2017
• Study Start: January 11, 2023
• Primary Completion: November 17, 2024
• Study Completion: December 13, 2024
• Last Updated: January 14, 2026
• Results First Posted: January 14, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)