Chronic Kidney DiseaseTEACH-VETNCT04064086
Trial to Evaluate and Assess the Effect of Comprehensive Pre-ESKD Education on Home Dialysis Use in Veterans
A study testing Comprehensive Pre-ESRD Patient Education (CPE) and Provision of the freely available resources for Kidney Disease Education in people with Chronic Kidney Disease and End Stage Renal Disease, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study is intended to correct an important systemic deficit in the care of chronic kidney disease (CKD), VHA's fourth most common healthcare condition with high mortality and healthcare burden. Currently, many Veterans with CKD have poor awareness of their condition. This leads to suboptimal care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, End Stage Renal Disease, Hemodialysis
- What is being tested?
- Comprehensive Pre-ESRD Patient Education (CPE) and Provision of the freely available resources for Kidney Disease Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 656 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2020to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans registered to receive healthcare from the NF/SG VHS
- 18 years or older
- Advanced CKD (stage 4 or 5) and not on dialysis
Who cannot join
- Non-English speakers
- Veterans who are homeless or living in assisted living facilities or nursing homes
- Veterans with diagnosed dementia
- Veterans with the life-expectancy less than 6 months
- Any additional special concerns of a Veteran's provider
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608-1135
About this study
Official title: A Patient-centered, System-based Approach to Improve Informed Dialysis Choice and Outcomes in Veterans With CKD
This study is intended to correct an important systemic deficit in the care of chronic kidney disease (CKD), VHA's fourth most common healthcare condition with high mortality and healthcare burden. Currently, many Veterans with CKD have poor awareness of their condition. This leads to suboptimal care. The investigators anticipate that the proposed comprehensive pre-end stage renal disease (ESRD) education (CPE) will enhance Veterans' CKD knowledge and their confidence in making an informed selection of an appropriate dialysis modality, and lead to an increase in the use of home dialysis (HoD) - an evidence-based, yet underutilized dialysis modality. Further, this study will allow us to examine whether such Veteran-informed dialysis choice can improve Veteran and health services outcomes. If successful, this study may deliver a ready to roll-out strategy to meet the CKD care needs of the Veterans and reduce VHA healthcare costs.
Read the detailed description
Chronic kidney disease (CKD) is the 4th most common diagnosis among Veterans. Each year, over 13,000 Veterans transition from CKD to end stage renal disease (ESRD), a disease with high mortality and poor health related quality of life (HRQoL). Over 52,000 Veterans with ESRD are currently on dialysis and CKD/ESRD care costs VA over $18 billion per year. The majority of Veterans progressing from CKD to ESRD have limited to no awareness of CKD and its treatment options. This hinders Veterans' informed dialysis selection resulting in a gross underuse (7%) of home dialysis (HoD). As there are no significant differences in mortality among different dialysis modalities, VHA National Kidney Program and professional renal societies advocate informed dialysis selection and greater use of HoD to facilitate improvements in Veterans' post-ESRD clinical and health services utilization outcomes.
Reports from Europe and Canada show that providing comprehensive pre-ESRD patient education (CPE) improves the quality of CKD care and empowers patients to make informed dialysis modality selection. Data further show that informed modality selection substantially corrects the underuse of HoD as desired by the healthcare systems, including VHA.
However, across VHA, many Veterans with CKD are identified too late to benefit from CPE; and even for those identified and under renal care, the availability of CPE is limited. This results in suboptimal pre-ESRD care and preparation, and continued low HoD utilization. Thus, there is an urgent systemic need to provide CPE to all pre-ESRD (stage 4 and 5 CKD) Veterans and study its effectiveness prospectively within the VHA.
This study aims to evaluate the impact of the comprehensive pre-ESRD patient education on high-impact outcomes for Veterans and health services, across a local Veterans Healthcare System (VHS). The investigators will compare the impact of CPE (intervention), delivered either in-person or through telemedicine, with the usual care (control) enhanced by the provision of the self-learning CKD information among Veterans with advanced CKD across the North Florida/South Georgia VHS.
The investigators' study has four aims, consisting of one primary outcome (HoD use) and multiple secondary outcomes, to help us understand the impact of CPE on patients' informed decision making and on important post-ESRD clinical, patient-reported, and health services outcomes.
Aim 1: Compare the impact of CPE on Veterans' knowledge of CKD, their confidence in dialysis decision making, and their selection of dialysis modality, between the CPE and usual care groups.
H1.1: CPE will improve Veterans' knowledge of CKD and its management. H1.2: CPE will improve Veterans' confidence in making an informed selection of a dialysis modality.
H1.3: CPE will increase Veterans' selection of HoD. Aim 2: Compare Veterans' actual use of HoD (Primary Outcome) between the CPE and usual care groups.
H2.1: Veterans in the CPE group will show increased HoD use. Aim 3: Examine Veterans' perceived satisfaction with CPE, explore their preferences for F2F- or Tele-CPE, and investigate barriers and facilitators in the selection and use of their preferred dialysis modality. (Qualitative) Aim 4: Compare the following post-ESRD secondary outcomes between the CPE and usual care groups.
Patient reported outcomes: 1) health-related quality of life and 2) satisfaction with dialysis; clinical outcomes: 3) time to ESRD, 4) estimated glomerular filtration rate at ESRD, 5) need for inpatient initiation of dialysis, and 6) vascular access status at ESRD; and health services utilization outcomes: 7) number of inpatient stays, and 8) number of outpatient visits, from enrollment to 90-day post ESRD period.
H4: Veterans in the CPE group will show improvement in these secondary outcomes.
Findings from this study will help to achieve the long-term goal of better meeting the needs of Veterans with advanced CKD by improving Veterans' knowledge of CKD and its management, and promoting evidence-based Veteran-centered ESRD care.
- Being tested
- Comprehensive Pre-ESRD Patient Education (CPE), Provision of the freely available resources for Kidney Disease Education
- Keywords
- Chronic kidney disease, Pre-dialysis education, Kidney Disease Education, Patient Education, Decision Making
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Pre-ESRD Patient Education (CPE)Other
Also called Kidney Disease Education, CKD education, dialysis education
Structured education session/s
Provision of the freely available resources for Kidney Disease EducationOther
Also called information brochure
freely available resources
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Pre-ESRD Patient Education (CPE) | Active comparator | These patients will receive CPE for a total of up to 3 session in an intent-to-teach format, either via Face-to-face or telemedicine delivery. Receives: Other: Comprehensive Pre-ESRD Patient Education (CPE) |
| Enhanced Usual Care | Active comparator | This group will receive usual care. This care will be enhanced by providing them with the freely available education material for the Kidney Disease Education Receives: Other: Provision of the freely available resources for Kidney Disease Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Home Dialysis Use
Patient receiving either CPE or Enhanced usual care (EUC) will be followed for the diagnosis of ESRD and initiation of dialysis. The investigators will follow the use of peritoneal dialysis or home hemodialysis at day 90 into the dialysis as the home dialysis (HoD) use primary outcome.
Measured: 0-48 months
Secondary outcomes (5)
Home Dialysis selection
post-CPE/EUC dialysis modality selection and examining the rates of home dialysis selection. post-CPE assessments will be made when subject is deemed confident in dialysis selection (see selection outcome). Post-EUC assessments will be made 10 days after the provision of the education material.
Measured: 0-4 weeks
Kidney Disease Knowledge
pre- and post- kidney disease knowledge assessments after CPE/EUC. post-CPE assessments will be made when subject is deemed confident in dialysis selection (see selection outcome). Post-EUC assessments will be made 10 days after the provision of the education material.
Measured: 0-4 weeks
confidence in dialysis decision making
post-CPE/EUC confidence in dialysis decision making. ). Intent-to-Teach will be assessed by confidence for dialysis decision making (defined by confidence rating of "quite confident" or "very confident"); those with suboptimal scores ("not at all confident" or "a little confident") or "uncertain of the dialysis modality choice," will undergo repeat CPE sessions weekly for up to 3 sessions. Based on our pilot studies showing the need for about 1.7 CPE session, the investigators expect that patients enrolled in CPE group will do post-CPE Aim 1 data collection (secondary outcome) at an average of 10 days
Measured: 0-4 weeks
post-ESRD Kidney Disease Quality of life-36
post CPE/EUC. This will only be measured in subjects that start dialysis therapy, 90 days post initiation of dialysis.
Measured: 3-48 months
Satisfaction on Dialysis
post CPE/EUC. This will only be measured in subjects that start dialysis therapy, 90 days post initiation of dialysis.
Measured: 3-48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start25 Mar 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 656 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ashutosh M. Shukla, MD MBBS, Principal investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064086
- Sponsor's protocol ID
- IIR 19-202
- Other IDs
- I01HX002639
- Acronym
- TEACH-VET
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2019
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shukla AM, Cavanaugh KL, Jia H, Hale-Gallardo J, Wadhwa A, Fischer MJ, Reule S, Palevsky PM, Fried LF, Crowley ST. Needs and Considerations for Standardization of Kidney Disease Education in Patients with Advanced CKD. Clin J Am Soc Nephrol. 2023 Sep 1;18(9):1234-1243. doi: 10.2215/CJN.0000000000000170. Epub 2023 May 8.
PubMed 37150877Campbell-Montalvo R, Ftouni D, Shell P, Subhash S, Pearce K, Shukla AM. Understanding how patient education affects the process of treatment decision-making: Cultural model change in kidney disease therapy. Patient Educ Couns. 2025 Oct;139:109254. doi: 10.1016/j.pec.2025.109254. Epub 2025 Jul 5.
PubMed 40663840Pearce KE, Guo Y, Subhash S, Ftouni D, Visconti B, Wadhwa A, Agarwal A, Jia H, Shukla AM. Decision Readiness and Determinants of KRT among Veterans with Advanced CKD. Clin J Am Soc Nephrol. 2025 Apr 11;20(7):931-939. doi: 10.2215/CJN.0000000713.
PubMed 40215111Shukla AM, Visconti B, Pearce K, Orozco T, Hale-Gallardo J, Subhash S, Freytes IM, Jia H, Romero S, Guo Y. Development and Validation of KRT Knowledge Instrument. Clin J Am Soc Nephrol. 2024 Jul 1;19(7):877-886. doi: 10.2215/CJN.0000000000000472. Epub 2024 May 15.
PubMed 38748976Chamarthi G, Orozco T, Hale-Gallardo J, Subhash S, Shell P, Pearce K, Jia H, Shukla AM. Informed Dialysis Modality Selection Among Veterans With Advanced CKD: A Community-Level Needs Assessment. Kidney Med. 2024 Apr 26;6(6):100832. doi: 10.1016/j.xkme.2024.100832. eCollection 2024 Jun.
PubMed 38873241Chamarthi G, Orozco T, Shell P, Fu D, Hale-Gallardo J, Jia H, Shukla AM. Electronic Phenotype for Advanced Chronic Kidney Disease in a Veteran Health Care System Clinical Database: Systems-Based Strategy for Model Development and Evaluation. Interact J Med Res. 2023 Jul 24;12:e43384. doi: 10.2196/43384.
PubMed 37486757Campbell-Montalvo R, Jia H, Shukla AM. Supporting Shared Decision-Making and Home Dialysis in End-Stage Kidney Disease. Int J Nephrol Renovasc Dis. 2022 Sep 8;15:229-237. doi: 10.2147/IJNRD.S375347. eCollection 2022.
PubMed 36105650Orozco T, Segal E, Hinkamp C, Olaoye O, Shell P, Shukla AM. Development and validation of an end stage kidney disease awareness survey: Item difficulty and discrimination indices. PLoS One. 2022 Sep 9;17(9):e0269488. doi: 10.1371/journal.pone.0269488. eCollection 2022.
PubMed 36083893Shukla AM, Hale-Gallardo J, Orozco T, Freytes I, Purvis Z, Romero S, Jia H. A randomized controlled trial to evaluate and assess the effect of comprehensive pre-end stage kidney disease education on home dialysis use in veterans, rationale and design. BMC Nephrol. 2022 Mar 30;23(1):121. doi: 10.1186/s12882-022-02740-8.
PubMed 35354430Shukla AM, Cavanaugh KL, Wadhwa A, Crowley ST, Fried L. Basic Requirements for Improving Home Dialysis Utilization: Universal Access to Specialty Nephrology Care and Comprehensive Pre-ESKD Education. J Am Soc Nephrol. 2023 Jan 1;34(1):21-25. doi: 10.1681/ASN.2022060685. Epub 2022 Oct 25. No abstract available.
PubMed 36283810Cheng XBJ, Chan CT. Systems Innovations to Increase Home Dialysis Utilization. Clin J Am Soc Nephrol. 2024 Jan 1;19(1):108-114. doi: 10.2215/CJN.0000000000000298. Epub 2023 Aug 31.
PubMed 37651291
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-centered, System-based Approach to Improve Informed Dialysis Choice and Outcomes in Veterans With CKD
- ClinicalTrials.gov ID
- NCT04064086
- Acronym / sponsor ID
- TEACH-VET / IIR 19-202
- Keywords
- Chronic kidney disease, Pre-dialysis education, Kidney Disease Education, Patient Education, Decision Making
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 656 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 21 Aug 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.
This study is intended to correct an important systemic deficit in the care of chronic kidney disease (CKD), VHA's fourth most common healthcare condition with high mortality and healthcare burden. Currently, many Veterans with CKD have poor awareness of their condition. This leads to suboptimal care. The investigators anticipate that the proposed comprehensive pre-end stage renal disease (ESRD) education (CPE) will enhance Veterans' CKD knowledge and their confidence in making an informed selection of an appropriate dialysis modality, and lead to an increase in the use of home dialysis (HoD) - an evidence-based, yet underutilized dialysis modality. Further, this study will allow us to examine whether such Veteran-informed dialysis choice can improve Veteran and health services outcomes. If successful, this study may deliver a ready to roll-out strategy to meet the CKD care needs of the Veterans and reduce VHA healthcare costs.
Detailed description
Chronic kidney disease (CKD) is the 4th most common diagnosis among Veterans. Each year, over 13,000 Veterans transition from CKD to end stage renal disease (ESRD), a disease with high mortality and poor health related quality of life (HRQoL). Over 52,000 Veterans with ESRD are currently on dialysis and CKD/ESRD care costs VA over $18 billion per year. The majority of Veterans progressing from CKD to ESRD have limited to no awareness of CKD and its treatment options. This hinders Veterans' informed dialysis selection resulting in a gross underuse (7%) of home dialysis (HoD). As there are no significant differences in mortality among different dialysis modalities, VHA National Kidney Program and professional renal societies advocate informed dialysis selection and greater use of HoD to facilitate improvements in Veterans' post-ESRD clinical and health services utilization outcomes.
Reports from Europe and Canada show that providing comprehensive pre-ESRD patient education (CPE) improves the quality of CKD care and empowers patients to make informed dialysis modality selection. Data further show that informed modality selection substantially corrects the underuse of HoD as desired by the healthcare systems, including VHA.
However, across VHA, many Veterans with CKD are identified too late to benefit from CPE; and even for those identified and under renal care, the availability of CPE is limited. This results in suboptimal pre-ESRD care and preparation, and continued low HoD utilization. Thus, there is an urgent systemic need to provide CPE to all pre-ESRD (stage 4 and 5 CKD) Veterans and study its effectiveness prospectively within the VHA.
This study aims to evaluate the impact of the comprehensive pre-ESRD patient education on high-impact outcomes for Veterans and health services, across a local Veterans Healthcare System (VHS). The investigators will compare the impact of CPE (intervention), delivered either in-person or through telemedicine, with the usual care (control) enhanced by the provision of the self-learning CKD information among Veterans with advanced CKD across the North Florida/South Georgia VHS.
The investigators' study has four aims, consisting of one primary outcome (HoD use) and multiple secondary outcomes, to help us understand the impact of CPE on patients' informed decision making and on important post-ESRD clinical, patient-reported, and health services outcomes.
Aim 1: Compare the impact of CPE on Veterans' knowledge of CKD, their confidence in dialysis decision making, and their selection of dialysis modality, between the CPE and usual care groups.
H1.1: CPE will improve Veterans' knowledge of CKD and its management. H1.2: CPE will improve Veterans' confidence in making an informed selection of a dialysis modality.
H1.3: CPE will increase Veterans' selection of HoD. Aim 2: Compare Veterans' actual use of HoD (Primary Outcome) between the CPE and usual care groups.
H2.1: Veterans in the CPE group will show increased HoD use. Aim 3: Examine Veterans' perceived satisfaction with CPE, explore their preferences for F2F- or Tele-CPE, and investigate barriers and facilitators in the selection and use of their preferred dialysis modality. (Qualitative) Aim 4: Compare the following post-ESRD secondary outcomes between the CPE and usual care groups.
Patient reported outcomes: 1) health-related quality of life and 2) satisfaction with dialysis; clinical outcomes: 3) time to ESRD, 4) estimated glomerular filtration rate at ESRD, 5) need for inpatient initiation of dialysis, and 6) vascular access status at ESRD; and health services utilization outcomes: 7) number of inpatient stays, and 8) number of outpatient visits, from enrollment to 90-day post ESRD period.
H4: Veterans in the CPE group will show improvement in these secondary outcomes.
Findings from this study will help to achieve the long-term goal of better meeting the needs of Veterans with advanced CKD by improving Veterans' knowledge of CKD and its management, and promoting evidence-based Veteran-centered ESRD care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Pre-ESRD Patient Education (CPE) | Active comparator | Other: Comprehensive Pre-ESRD Patient Education (CPE)These patients will receive CPE for a total of up to 3 session in an intent-to-teach format, either via Face-to-face or telemedicine delivery. |
| Enhanced Usual Care | Active comparator | Other: Provision of the freely available resources for Kidney Disease EducationThis group will receive usual care. This care will be enhanced by providing them with the freely available education material for the Kidney Disease Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veterans registered to receive healthcare from the NF/SG VHS
- 18 years or older
- Advanced CKD (stage 4 or 5) and not on dialysis
Key exclusion criteria (5 listed)
- Non-English speakers
- Veterans who are homeless or living in assisted living facilities or nursing homes
- Veterans with diagnosed dementia
- Veterans with the life-expectancy less than 6 months
- Any additional special concerns of a Veteran's provider
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 |
|---|---|---|
| Comprehensive Pre-ESRD Patient Education (CPE)Also: Kidney Disease Education, CKD education, dialysis educationStructured education session/s | Other | Comprehensive Pre-ESRD Patient Education (CPE) |
| Provision of the freely available resources for Kidney Disease EducationAlso: information brochurefreely available resources | Other | Enhanced Usual Care |
Primary outcome
Home Dialysis Use
Time frame: 0-48 months
Patient receiving either CPE or Enhanced usual care (EUC) will be followed for the diagnosis of ESRD and initiation of dialysis. The investigators will follow the use of peritoneal dialysis or home hemodialysis at day 90 into the dialysis as the home dialysis (HoD) use primary outcome.
5 secondary outcomes
Home Dialysis selection
Time frame: 0-4 weeks
Kidney Disease Knowledge
Time frame: 0-4 weeks
confidence in dialysis decision making
Time frame: 0-4 weeks
post-ESRD Kidney Disease Quality of life-36
Time frame: 3-48 months
Satisfaction on Dialysis
Time frame: 3-48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Results publication: PubMed 37150877Shukla AM, Cavanaugh KL, Jia H, Hale-Gallardo J, Wadhwa A, Fischer MJ, Reule S, Palevsky PM, Fried LF, Crowley ST. Needs and Considerations for Standardization of Kidney Disease Education in Patients with Advanced CKD. Clin J Am Soc Nephrol. 2023 Sep 1;18(9):1234-1243. doi: 10.2215/CJN.0000000000000170. Epub 2023 May 8.
- Results publication: PubMed 40663840Campbell-Montalvo R, Ftouni D, Shell P, Subhash S, Pearce K, Shukla AM. Understanding how patient education affects the process of treatment decision-making: Cultural model change in kidney disease therapy. Patient Educ Couns. 2025 Oct;139:109254. doi: 10.1016/j.pec.2025.109254. Epub 2025 Jul 5.
- Results publication: PubMed 40215111Pearce KE, Guo Y, Subhash S, Ftouni D, Visconti B, Wadhwa A, Agarwal A, Jia H, Shukla AM. Decision Readiness and Determinants of KRT among Veterans with Advanced CKD. Clin J Am Soc Nephrol. 2025 Apr 11;20(7):931-939. doi: 10.2215/CJN.0000000713.
- Results publication: PubMed 38748976Shukla AM, Visconti B, Pearce K, Orozco T, Hale-Gallardo J, Subhash S, Freytes IM, Jia H, Romero S, Guo Y. Development and Validation of KRT Knowledge Instrument. Clin J Am Soc Nephrol. 2024 Jul 1;19(7):877-886. doi: 10.2215/CJN.0000000000000472. Epub 2024 May 15.
- Results publication: PubMed 38873241Chamarthi G, Orozco T, Hale-Gallardo J, Subhash S, Shell P, Pearce K, Jia H, Shukla AM. Informed Dialysis Modality Selection Among Veterans With Advanced CKD: A Community-Level Needs Assessment. Kidney Med. 2024 Apr 26;6(6):100832. doi: 10.1016/j.xkme.2024.100832. eCollection 2024 Jun.
- Results publication: PubMed 37486757Chamarthi G, Orozco T, Shell P, Fu D, Hale-Gallardo J, Jia H, Shukla AM. Electronic Phenotype for Advanced Chronic Kidney Disease in a Veteran Health Care System Clinical Database: Systems-Based Strategy for Model Development and Evaluation. Interact J Med Res. 2023 Jul 24;12:e43384. doi: 10.2196/43384.
- Results publication: PubMed 36105650Campbell-Montalvo R, Jia H, Shukla AM. Supporting Shared Decision-Making and Home Dialysis in End-Stage Kidney Disease. Int J Nephrol Renovasc Dis. 2022 Sep 8;15:229-237. doi: 10.2147/IJNRD.S375347. eCollection 2022.
- Results publication: PubMed 36083893Orozco T, Segal E, Hinkamp C, Olaoye O, Shell P, Shukla AM. Development and validation of an end stage kidney disease awareness survey: Item difficulty and discrimination indices. PLoS One. 2022 Sep 9;17(9):e0269488. doi: 10.1371/journal.pone.0269488. eCollection 2022.
- Results publication: PubMed 35354430Shukla AM, Hale-Gallardo J, Orozco T, Freytes I, Purvis Z, Romero S, Jia H. A randomized controlled trial to evaluate and assess the effect of comprehensive pre-end stage kidney disease education on home dialysis use in veterans, rationale and design. BMC Nephrol. 2022 Mar 30;23(1):121. doi: 10.1186/s12882-022-02740-8.
- Results publication: PubMed 36283810Shukla AM, Cavanaugh KL, Wadhwa A, Crowley ST, Fried L. Basic Requirements for Improving Home Dialysis Utilization: Universal Access to Specialty Nephrology Care and Comprehensive Pre-ESKD Education. J Am Soc Nephrol. 2023 Jan 1;34(1):21-25. doi: 10.1681/ASN.2022060685. Epub 2022 Oct 25. No abstract available.
- Derived from this study: PubMed 37651291Cheng XBJ, Chan CT. Systems Innovations to Increase Home Dialysis Utilization. Clin J Am Soc Nephrol. 2024 Jan 1;19(1):108-114. doi: 10.2215/CJN.0000000000000298. Epub 2023 Aug 31.
- Individual participant dataSharing planned: No
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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.
Ashutosh M. Shukla, MD MBBS principal investigator
North Florida/South Georgia Veterans Health System, Gainesville, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Pre-ESRD Patient Education (CPE) and Provision of the freely available resources for Kidney Disease Education in people with Chronic Kidney Disease and End Stage Renal Disease, run by VA Office of Research and Development 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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Home Dialysis Use (time frame: 0-48 months). 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 NCT04064086, which also lists 11 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 15 Sep 2026.