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peer navigator for Dialysis in Racial/Ethnic Minorities

N/A
Recruiting
Research Sponsored by Denver Health and Hospital Authority
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with end-stage kidney disease
No active substance use (e.g. heavy etoh or opiates)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed twice: at time of enrollment and at time of study completion (up to 1 year)
Awards & highlights

Study Summary

This trial will assess the feasibility of a 1-arm intervention of a 5-visit lay Peer Navigator intervention to support Latino ESRD patients with social challenges and adherence.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a serious kidney disease that is in its final stage.
Select...
You are not currently using drugs or alcohol excessively.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed twice: at time of enrollment and at time of study completion (up to 1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed twice: at time of enrollment and at time of study completion (up to 1 year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Interdialytic weight gain
Secondary outcome measures
Albumin
Emergency Department visits and hospitalizations
Hemodialysis adherence
+10 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: peer navigatorActive Control1 Intervention
The first PN visit will take place within 1-2 weeks of consent. Each of the 5 subsequent PN visits will take place every 1-2 weeks. We expect patients to complete the intervention within 2-3 months of consent. The function of the initial visit is to establish trust and ensure a more personal approach with participants. The community-based PN intervention is grounded in core Latino values (e.g. trust, personalized relationships). The core elements of the PN intervention include patient motivational interviewing as well as patient activation, empowerment (e.g. help with scheduling of healthcare appointments and re-scheduling of missed HD sessions), education (e.g. education of ESKD and need for renal replacement therapy), and social challenges (e.g. access to resources for transportation, benefits, immigration issues). The duration, individuals present during the visit, and content discussed will be documented in the visit form.
Group II: Control Arm (standard of care)Placebo Group1 Intervention
Standard of care

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,338 Previous Clinical Trials
4,314,059 Total Patients Enrolled
Denver Health and Hospital AuthorityLead Sponsor
101 Previous Clinical Trials
400,275 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,726 Previous Clinical Trials
2,141,536 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially qualify for this medical study?

"This medical investigation requires the enrolment of 140 patients, belonging to a racial/ethnic minority and undergoing dialysis. The inclusion criteria necessitates that these participants be between 18 and 90 years old."

Answered by AI

What is the total enrollment of participants for this clinical research?

"Affirmative. According to the information on clinicaltrials.gov, this study is actively searching for recruits since its initial post date of October 5th 2020 and most recent update on July 24th 2022. The trial requires 140 participants from a single site."

Answered by AI

Is this research project open to applicants over the age of 20?

"According to the requirements for this study, individuals must be over 18 years of age and below 90 in order to join."

Answered by AI

Are any volunteers being recruited for this investigation?

"Clinicaltrials.gov indicates that this experiment, which was first advertised on October 5th 2020, is still searching for participants. It has been modified as recently as July 24th 2022."

Answered by AI
Recent research and studies
~32 spots leftby Mar 2025