Racial/Ethnic Minorities on DialysisNCT03978806

Prosperando: Fostering Resilience on Dialysis

A study testing Active Comparator: peer navigator in people with Racial/Ethnic Minorities on Dialysis, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Racial/Ethnic Minorities on Dialysis
What is being tested?: Active Comparator: peer navigator
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 139 participants
Where: 1 siteUnited States
Study dates: 5 Oct 2020to 7 Jul 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Self-identify as Latino
Age between 18 and 90 years
Diagnosed with end-stage kidney disease
Received standard (thrice-weekly HD) for at least 3 months
No active substance use (e.g. heavy etoh or opiates)
Speak English or Spanish as a primary language
Participants must be able to provide informed consent

Who cannot join

Active suicidal intent
Present or past psychosis or bipolar disorder
Patient to receive kidney transplantation in the next 3 months

Trial locations and contacts

1 site in 1 country.

United States1 site

Fresenius Medical Care Rocky Mountain Dialysis
Denver, Colorado, 80220

Other trials in United States

About this study

Official title: Fostering Resilience on Dialysis: A Peer Navigator Study to Improve the Well-being of Latinos on Hemodialysis

Latinos with End-Stage Renal Disease (ESRD) represent 17% of the US adult ESRD community and suffer a disproportionate burden of social challenges that impacts their well-being. With support from the Amos award from the Robert Wood Johnson Foundation (RWJF), the investigators assessed 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 (using motivational interviewing \& patient activation). This trial will build on the Amos work as a small Randomized Controlled Trial (RCT). The overall aims of this proposal are to: 1) engage key operational and clinical stakeholders early-on to develop a Peer Navigator-intervention; 2) conduct a pilot RCT of the peer navigator intervention versus standard care to test feasibility and acceptability; and 3) assess the efficacy of the intervention on interdialytic weight gain (primary outcome) as well as health-related quality of life, patient activation, and hemodialysis adherence (secondary outcomes).

Read the detailed description

The goal of this project is to assess the feasibility and acceptability of a pilot RCT of a culturally tailored peer-navigator (PN) intervention to improve patient-centered and clinical outcomes for Latino patients with end-stage kidney disease (ESKD). We will compare a culturally tailored intervention that includes a PN to control (standard care). In the culturally tailored intervention, the bilingual PN will provide support with social challenges during 5 visits. We will assess the feasibility of (1) referral, (2) recruitment, (3) retention, (4) intervention implementation, and (5) data collection. We will also assess various outcomes including inter-dialytic weight gain and other adherence and patient-centered outcomes.

Specific Aim 1: Conduct a pilot RCT of the peer navigator intervention to assess feasibility, acceptability, as well as outcomes of the proposed peer navigator intervention.

Hypothesis 1: A culturally tailored intervention that consists of a bilingual/culture-concordant peer navigator that provides support with social challenges and support with adherence using motivational interviewing for Latino end-stage kidney disease (ESKD) patients, is feasible and acceptable.

Conditions: Racial/Ethnic Minorities on Dialysis
Being tested: Active Comparator: peer navigator, Placebo Comparator: Control Arm (standard of care)
Keywords: Latino, Hispanic, Dialysis, Navigator, Community health worker

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Active Comparator: peer navigatorBehavioural
The intervention is aimed to provide support with social challenges and adherence. The peer navigator will meet with patients to provide support with social challenges and use motivational interviewing to provide support with adherence.
Placebo Comparator: Control Arm (standard of care)Other
Control patients will have met the same inclusion and exclusion criteria as intervention patients.

Study groups in NCT03978806
Study group	Role	What they receive
peer navigator	Active comparator	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. Receives: Behavioral: Active Comparator: peer navigator
Control Arm (standard of care)	Placebo comparator	Standard of care Receives: Other: Placebo Comparator: Control Arm (standard of care)

What is being measured

The primary outcome is the main question the study is designed to answer.

Interdialytic weight gain
Inter-dialytic weight gain will be calculated as the monthly average of the difference between the pre-dialysis weight and the weight at the end of the previous dialysis session, divided by determined dry weight, expressed as a percentage of change in weight per day (%Δkg per day).
Measured: Data collection 3 months prior to consent (collected retrospectively) and 6 months following study completion

Secondary outcomes (13)

Kidney Dialysis Quality of Life Short Form - 36 questions
KDQOL(Kidney Disease Quality Of Life) - Short Form 36 (SF-36). The KDQOL Short Form-36 (KDQOL-SF-36), a 36 item survey with five subscales (Physical Component Summary, Mental Component Summary, Burden of Kidney Disease subscale, Symptoms and Problems subscale, and Effects of Kidney Disease on Daily Life). The KDQOL-SF-36 are scored linearly (with higher score indicating better quality of life) on a range of 0-100 using the developer-recommended scoring (available at https://www.rand.org/health-care/surveys_tools/kdqol.html).
Measured: Change from baseline health-related quality of life up to 24 months
Hemodialysis shortening
Hemodialysis shortening: Defined as shortening the hemodialysis session by greater than or equal to 10 minutes.
Measured: This will be monitored beginning 3 months prior to enrollment and then 3 months following study completion up to 24 months. Detailed: Monthly for 3 months prior to enrollment, monthly during study and then monthly for 3 months after study completion.
Hemodialysis adherence
Hemodialysis adherence defined defined as the proportion of monthly scheduled sessions missed (other than for vacation or hospitalization)
Measured: This will be monitored beginning 3 months prior to enrollment and then 3 months following study completion up to 24 months. Detailed: Monthly for 3 months prior to enrollment, monthly during study and then monthly for 3 months after study completion.
Albumin
Albumin
Measured: This will be monitored beginning 3 months prior to enrollment and then 3 months following study completion up to 24 months. Detailed: Monthly for 3 months prior to enrollment, monthly during study and then monthly for 3 months after study completion.
Potassium
Potassium
Measured: This will be monitored beginning 3 months prior to enrollment and then 3 months following study completion up to 24 months. Detailed: Monthly for 3 months prior to enrollment, monthly during study and then monthly for 3 months after study completion.
Phosphorus
Phosphorus
Measured: Assessed 3 months prior to enrollment, monitored monthly during intervention, and followed for 3 months after intervention
Social determinants of health composite survey
Several questions from various previously validated surveys that assess social determinants of health.
Measured: Assessed at twice: At time of enrollment and at time of study completion (up to 1 year)
Self-Efficacy
Patient-Reported Outcomes Measurement Information System (PROMIS) measure to assess self-efficacy
Measured: Assessed at twice: At time of enrollment and at time of study completion (up to 1 year)
Patient Activation Measure
Patient Activation Measure has 13 questions, each item is rated on a four-point scale (1 strong disagree to 4 strong agree, with additional 'non-applicable.' Level 1 (less than 47) indicates 'not believing activation is important.' Level 2 (47 to 55.1) indicates 'a lack of knowledge and confidence to take action.' Level 3 (55.2 to 67) indicates 'beginning to take action.' Level 4 (greater than 67) indicates 'taking action.'
Measured: Assessed at twice: At time of enrollment and at time of study completion (up to 1 year)
Emergency Department visits and hospitalizations
Number of Emergency Department (ED) visits and hospitalizations, length of stay
Measured: Assessed at twice: At time of enrollment and at time of study completion (up to 1 year)
Social Isolation
PROMIS measure
Measured: Assessed twice: At time of enrollment and at time of study completion (up to 1 year)
Qualitative interviews to assess acceptability
10 participants will be interviewed using semi-structured approach. The results will be a thematic analysis (that ties in the themes and subthemes with illustrative quotes).
Measured: Assessed twice: At time of enrollment and at time of study completion (up to 1 year)
Kidney transplantation Questions derived/tailored from two previously published questionnaires.
Kidney transplantation interest in pursuing, placement on list, receipt of transplantation. Questions were derived and tailored from two studies: Ayanian NEJM 1999;341:1661-9 \& Bouleware American J of Transplantation 2005;5:1503-1512. Some are yes/no questions and others are on a Likert Scale.
Measured: Assessed twice: At time of enrollment and at time of study completion (up to 1 year)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 20207 Jul 2024

First posted7 Jun 2019
Study start5 Oct 2020
Primary completion7 Jul 2024
Study completion7 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Racial/Ethnic Minorities on DialysisStudies of the same condition, open and under way.
More trials run by University of Colorado, DenverThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: This will be a pilot RCT (randomized controlled trial) of a 3 month intervention of Latino ESRD patients that will be randomized to one of two arms: 1) PN Arm, in which a bilingual PN provides support with social factors and support with adherence using motivational interviewing during 5 visits or 2) Control (standard care) Arm.
Masking: Single blind
Who is masked: Investigator
Enrolment: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03978806
Sponsor's protocol ID: 20-0419
Status last verified: Oct 2024
First submitted: 30 May 2019
Last updated: 21 Oct 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: There is no plan to share individual participant data at this time. If this changes, this section will be modified.

Publications

Cukor D, Ver Halen N, Asher DR, Coplan JD, Weedon J, Wyka KE, Saggi SJ, Kimmel PL. Psychosocial intervention improves depression, quality of life, and fluid adherence in hemodialysis. J Am Soc Nephrol. 2014 Jan;25(1):196-206. doi: 10.1681/ASN.2012111134. Epub 2013 Oct 10.
PubMed 24115478
Lora CM, Ricardo AC, Brecklin CS, Fischer MJ, Rosman RT, Carmona E, Lopez A, Balaram M, Nessel L, Tao KK, Xie D, Kusek JW, Go AS, Lash JP. Recruitment of Hispanics into an observational study of chronic kidney disease: the Hispanic Chronic Renal Insufficiency Cohort Study experience. Contemp Clin Trials. 2012 Nov;33(6):1238-44. doi: 10.1016/j.cct.2012.07.012. Epub 2012 Jul 27.
PubMed 22841929
Cervantes L, Jones J, Linas S, Fischer S. Qualitative Interviews Exploring Palliative Care Perspectives of Latinos on Dialysis. Clin J Am Soc Nephrol. 2017 May 8;12(5):788-798. doi: 10.2215/CJN.10260916. Epub 2017 Apr 12.
PubMed 28404600
Cervantes L, Linas S, Keniston A, Fischer S. Latinos With Chronic Kidney Failure Treated by Dialysis: Understanding Their Palliative Care Perspectives. Am J Kidney Dis. 2016 Feb;67(2):344-7. doi: 10.1053/j.ajkd.2015.09.026. Epub 2015 Nov 20. No abstract available.
PubMed 26612276
Cervantes L, Chonchol M, Hasnain-Wynia R, Steiner JF, Havranek E, Hull M, Rice J, Kendrick J, Alamillo X, Camacho C, Fischer S. Peer Navigator Intervention for Latinos on Hemodialysis: A Single-Arm Clinical Trial. J Palliat Med. 2019 Jul;22(7):838-843. doi: 10.1089/jpm.2018.0439. Epub 2019 Jan 31.
PubMed 30702365
Cervantes L, Hull M, Keniston A, Chonchol M, Hasnain-Wynia R, Fischer S. Symptom Burden among Latino Patients with End-Stage Renal Disease and Access to Standard or Emergency-Only Hemodialysis. J Palliat Med. 2018 Sep;21(9):1329-1333. doi: 10.1089/jpm.2017.0663. Epub 2018 May 30.
PubMed 29847204
Cervantes L, Zoucha J, Jones J, Fischer S. Experiences and Values of Latinos with End Stage Renal Disease: A Systematic Review of Qualitative Studies. Nephrol Nurs J. 2016 Nov-Dec;43(6):479-493.
PubMed 30550077
Fischer SM, Cervantes L, Fink RM, Kutner JS. Apoyo con Carino: a pilot randomized controlled trial of a patient navigator intervention to improve palliative care outcomes for Latinos with serious illness. J Pain Symptom Manage. 2015 Apr;49(4):657-65. doi: 10.1016/j.jpainsymman.2014.08.011. Epub 2014 Sep 18.
PubMed 25240788
Cervantes L, Juarez-Colunga E, Powe NR, Flythe JE, Steiner JF, Cukor D, Hasnain-Wynia R, Furgeson S, Golestaneh L, Camacho C, McBeth L, Beaty BL, Shi J, Bacon E, Chonchol M. Community Health Worker Support for Hispanic and Latino Individuals Receiving Hemodialysis: The Navigate-Kidney Randomized Clinical Trial. JAMA Intern Med. 2026 Jan 1;186(1):56-66. doi: 10.1001/jamainternmed.2025.5305.
PubMed 41203234

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fostering Resilience on Dialysis: A Peer Navigator Study to Improve the Well-being of Latinos on Hemodialysis
ClinicalTrials.gov ID: NCT03978806
Acronym / sponsor ID: 20-0419
Conditions: Racial/Ethnic Minorities on Dialysis
Keywords: Latino, Hispanic, Dialysis, Navigator, Community health worker
Study type: Interventional
Recruitment status: Completed
Enrolment: 139 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: 5 Oct 2020 (actual)
Primary completion: 7 Jul 2024 (actual)
Study completion: 7 Jul 2024 (actual)
First posted: 7 Jun 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Specific Aim 1: Conduct a pilot RCT of the peer navigator intervention to assess feasibility, acceptability, as well as outcomes of the proposed peer navigator intervention.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
Model description: This will be a pilot RCT (randomized controlled trial) of a 3 month intervention of Latino ESRD patients that will be randomized to one of two arms: 1) PN Arm, in which a bilingual PN provides support with social factors and support with adherence using motivational interviewing during 5 visits or 2) Control (standard care) Arm.

Arm	Type	Receives
peer navigator	Active comparator	Behavioral: Active Comparator: peer navigatorThe 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.
Control Arm (standard of care)	Placebo comparator	Other: Placebo Comparator: Control Arm (standard of care)Standard of care

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Self-identify as Latino
Age between 18 and 90 years
Diagnosed with end-stage kidney disease
Received standard (thrice-weekly HD) for at least 3 months
No active substance use (e.g. heavy etoh or opiates)

Key exclusion criteria (3 listed)

Active suicidal intent
Present or past psychosis or bipolar disorder
Patient to receive kidney transplantation in the next 3 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Active Comparator: peer navigatorThe intervention is aimed to provide support with social challenges and adherence. The peer navigator will meet with patients to provide support with social challenges and use motivational interviewing to provide support with adherence.	Behavioural	peer navigator
Placebo Comparator: Control Arm (standard of care)Control patients will have met the same inclusion and exclusion criteria as intervention patients.	Other	Control Arm (standard of care)

Primary outcome

Interdialytic weight gain
Time frame: Data collection 3 months prior to consent (collected retrospectively) and 6 months following study completion
Inter-dialytic weight gain will be calculated as the monthly average of the difference between the pre-dialysis weight and the weight at the end of the previous dialysis session, divided by determined dry weight, expressed as a percentage of change in weight per day (%Δkg per day).

13 secondary outcomes

Kidney Dialysis Quality of Life Short Form - 36 questions
Time frame: Change from baseline health-related quality of life up to 24 months
Hemodialysis shortening
Time frame: This will be monitored beginning 3 months prior to enrollment and then 3 months following study completion up to 24 months. Detailed: Monthly for 3 months prior to enrollment, monthly during study and then monthly for 3 months after study completion.
Hemodialysis adherence
Time frame: This will be monitored beginning 3 months prior to enrollment and then 3 months following study completion up to 24 months. Detailed: Monthly for 3 months prior to enrollment, monthly during study and then monthly for 3 months after study completion.
Albumin
Time frame: This will be monitored beginning 3 months prior to enrollment and then 3 months following study completion up to 24 months. Detailed: Monthly for 3 months prior to enrollment, monthly during study and then monthly for 3 months after study completion.
Potassium
Time frame: This will be monitored beginning 3 months prior to enrollment and then 3 months following study completion up to 24 months. Detailed: Monthly for 3 months prior to enrollment, monthly during study and then monthly for 3 months after study completion.
Phosphorus
Time frame: Assessed 3 months prior to enrollment, monitored monthly during intervention, and followed for 3 months after intervention
Social determinants of health composite survey
Time frame: Assessed at twice: At time of enrollment and at time of study completion (up to 1 year)
Self-Efficacy
Time frame: Assessed at twice: At time of enrollment and at time of study completion (up to 1 year)
Patient Activation Measure
Time frame: Assessed at twice: At time of enrollment and at time of study completion (up to 1 year)
Emergency Department visits and hospitalizations
Time frame: Assessed at twice: At time of enrollment and at time of study completion (up to 1 year)
Social Isolation
Time frame: Assessed twice: At time of enrollment and at time of study completion (up to 1 year)
Qualitative interviews to assess acceptability
Time frame: Assessed twice: At time of enrollment and at time of study completion (up to 1 year)
Kidney transplantation Questions derived/tailored from two previously published questionnaires.
Time frame: Assessed twice: At time of enrollment and at time of study completion (up to 1 year)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
Background: PubMed 24115478Cukor D, Ver Halen N, Asher DR, Coplan JD, Weedon J, Wyka KE, Saggi SJ, Kimmel PL. Psychosocial intervention improves depression, quality of life, and fluid adherence in hemodialysis. J Am Soc Nephrol. 2014 Jan;25(1):196-206. doi: 10.1681/ASN.2012111134. Epub 2013 Oct 10.
Background: PubMed 22841929Lora CM, Ricardo AC, Brecklin CS, Fischer MJ, Rosman RT, Carmona E, Lopez A, Balaram M, Nessel L, Tao KK, Xie D, Kusek JW, Go AS, Lash JP. Recruitment of Hispanics into an observational study of chronic kidney disease: the Hispanic Chronic Renal Insufficiency Cohort Study experience. Contemp Clin Trials. 2012 Nov;33(6):1238-44. doi: 10.1016/j.cct.2012.07.012. Epub 2012 Jul 27.
Background: PubMed 28404600Cervantes L, Jones J, Linas S, Fischer S. Qualitative Interviews Exploring Palliative Care Perspectives of Latinos on Dialysis. Clin J Am Soc Nephrol. 2017 May 8;12(5):788-798. doi: 10.2215/CJN.10260916. Epub 2017 Apr 12.
Background: PubMed 26612276Cervantes L, Linas S, Keniston A, Fischer S. Latinos With Chronic Kidney Failure Treated by Dialysis: Understanding Their Palliative Care Perspectives. Am J Kidney Dis. 2016 Feb;67(2):344-7. doi: 10.1053/j.ajkd.2015.09.026. Epub 2015 Nov 20. No abstract available.
Background: PubMed 30702365Cervantes L, Chonchol M, Hasnain-Wynia R, Steiner JF, Havranek E, Hull M, Rice J, Kendrick J, Alamillo X, Camacho C, Fischer S. Peer Navigator Intervention for Latinos on Hemodialysis: A Single-Arm Clinical Trial. J Palliat Med. 2019 Jul;22(7):838-843. doi: 10.1089/jpm.2018.0439. Epub 2019 Jan 31.
Background: PubMed 29847204Cervantes L, Hull M, Keniston A, Chonchol M, Hasnain-Wynia R, Fischer S. Symptom Burden among Latino Patients with End-Stage Renal Disease and Access to Standard or Emergency-Only Hemodialysis. J Palliat Med. 2018 Sep;21(9):1329-1333. doi: 10.1089/jpm.2017.0663. Epub 2018 May 30.
Background: PubMed 30550077Cervantes L, Zoucha J, Jones J, Fischer S. Experiences and Values of Latinos with End Stage Renal Disease: A Systematic Review of Qualitative Studies. Nephrol Nurs J. 2016 Nov-Dec;43(6):479-493.
Background: PubMed 25240788Fischer SM, Cervantes L, Fink RM, Kutner JS. Apoyo con Carino: a pilot randomized controlled trial of a patient navigator intervention to improve palliative care outcomes for Latinos with serious illness. J Pain Symptom Manage. 2015 Apr;49(4):657-65. doi: 10.1016/j.jpainsymman.2014.08.011. Epub 2014 Sep 18.
Derived from this study: PubMed 41203234Cervantes L, Juarez-Colunga E, Powe NR, Flythe JE, Steiner JF, Cukor D, Hasnain-Wynia R, Furgeson S, Golestaneh L, Camacho C, McBeth L, Beaty BL, Shi J, Bacon E, Chonchol M. Community Health Worker Support for Hispanic and Latino Individuals Receiving Hemodialysis: The Navigate-Kidney Randomized Clinical Trial. JAMA Intern Med. 2026 Jan 1;186(1):56-66. doi: 10.1001/jamainternmed.2025.5305.
Individual participant dataSharing planned: Undecided. There is no plan to share individual participant data at this time. If this changes, this section will be modified.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active Comparator: peer navigator in people with Racial/Ethnic Minorities on Dialysis, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interdialytic weight gain (time frame: Data collection 3 months prior to consent (collected retrospectively) and 6 months following study completion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03978806, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.