Chronic Kidney DiseaseTHRiVENCT05997875
Transforming Hemodialysis-Related Vascular Access Education
A study testing Educational Materials, Motivational Interviewing and Patient Lists for Clinicians: System-Level Intervention in people with Chronic Kidney Disease and Hemodialysis Vascular Access, run by University of Pennsylvania at 3 sites in United States.
Trial summary
The focus of this study is on vascular access for hemodialysis. This is a randomized clinical trial testing 3 educational approaches to help patients with advanced chronic kidney disease prepare for placement of hemodialysis vascular access. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Hemodialysis Vascular Access
- What is being tested?
- Educational Materials, Motivational Interviewing and Patient Lists for Clinicians: System-Level Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Dec 2023to 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
- Age 18 years or older
- Nephrology visit for chronic kidney disease during the last 18 months
- Most recent eGFR less than or equal to 20 ml/min/1.73 m2 or 2-year Kidney Failure Risk Equation score greater than 40%
- Documentation in the medical record or confirmation from the treating nephrologist of a patient-nephrologist discussion about hemodialysis
Who cannot join
- Planning for peritoneal dialysis, preemptive transplant, or conservative management of kidney failure
- Previous placement of an AV access
- Prior appointment with surgeon for AV access evaluation or creation
- Cognitive dysfunction or severe visual impairment that prevents use of the education materials
- Does not speak either English or Spanish
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21218
Deidra Crews, MD, ScM, 410-502-0518, Dcrews1@jhmi.edu
Deidra Crews, MD, ScM
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Jennifer E. Flythe, MD, MPH
Jennifer E. Flythe, MD, MPH
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19106
Laura Dember, MD, 2155735264, ldember@pennmedicine.upenn.edu
Leah Bernardo, BA, 2157464755, lleah@pennmedicine.upenn.edu
About this study
Official title: Transforming Hemodialysis-Related Vascular Access Education (THRiVE)
The focus of this study is on vascular access for hemodialysis. This is a randomized clinical trial testing 3 educational approaches to help patients with advanced chronic kidney disease prepare for placement of hemodialysis vascular access. Study participants will each be assigned to one of the 3 approaches: 1) "Education", in which participants will be given a video and brochure that provide information about the types of vascular access and what can be expected before and after the vascular access is placed, 2) "Education-Plus", in which participants will be given the video and brochure and will also have sessions by telehealth with a motivational interviewing coach to provide additional support around vascular access placement, and 3) "Usual Care", in which participants will have the usual education provided by their kidney doctor and clinic staff just as if they were not in the study. Participants in all 3 groups will be asked to complete questionnaires by telephone and may be invited to be interviewed about their experience with the study intervention at the end of the study. Study participation will last for about 12 months, with most of the study activities taking place during the first 3 months.
- Being tested
- Educational Materials, Motivational Interviewing, Usual Care, Patient Lists for Clinicians: System-Level Intervention
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational MaterialsBehavioural
Participants are provided with the "Getting Ready: Your Vascular Access Journey" video and brochure about hemodialysis vascular access. The video is available for viewing via smartphone or computer. Both the brochure and video were created with input from patients with chronic kidney disease.
Motivational InterviewingBehavioural
Participants receive coaching with telehealth-based motivational interviewing designed to prepare participants to move forward with vascular access creation. Motivational interviewing will consist of a minimum of 3 and maximum of 8 telehealth sessions with a coach. The coach will use patient-centered communication skills to work though the stages of pre-contemplative, contemplative, preparation, action, and maintenance of an arteriovenous vascular access.
Usual CareBehavioural
Participants receive the non-standardized vascular access counseling and referral to the chronic kidney disease education class that comprises the standard care provided by their nephrology clinic.
Patient Lists for Clinicians: System-Level InterventionOther
Nephrologists and clinic staff receive monthly, provider-specific, lists of patients potentially appropriate for AV access planning based on eGFR thresholds and kidney failure risk. These criteria identify patients at risk for progression to dialysis and are congruent with evidence-based guidelines for optimal timing of AV access evaluation referral.
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | Not described Receives: Behavioral: Educational Materials; Behavioral: Usual Care; Other: Patient Lists for Clinicians: System-Level Intervention |
| Education-Plus | Experimental | Not described Receives: Behavioral: Educational Materials; Behavioral: Motivational Interviewing; Behavioral: Usual Care; Other: Patient Lists for Clinicians: System-Level Intervention |
| Usual Care | Other | Not described Receives: Behavioral: Usual Care; Other: Patient Lists for Clinicians: System-Level Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery for Creation of Hemodialysis Arteriovenous Access (Effectiveness outcome)
The proportion of participants who have arteriovenous access creation surgery.
Measured: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
Secondary outcomes (26)
Scheduled Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome)
The proportion of participants with a scheduled appointment with a surgeon for evaluation for vascular access creation.
Measured: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
Completed Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome)
The proportion of participants with a completed appointment with a surgeon for evaluation for vascular access creation.
Measured: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
Imaging for Planning Arteriovenous Vascular Access Creation (Effectiveness outcome)
The proportion of participants with completed vascular imaging via ultrasound or angiography for planning arteriovenous vascular access creation surgery.
Measured: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
Usable Arteriovenous Vascular Access (Effectiveness outcome)
For participants who start hemodialysis, the proportion with a usable arteriovenous access at dialysis initiation.
Measured: Up to 4 years after randomization (full duration of the trial)
Vascular Access Knowledge (Effectiveness outcome)
The change from baseline in vascular access knowledge as measured by the Patient Perceived Vascular Access Knowledge scale. The total score ranges from 0 to 10, with higher scores indicating a higher level of vascular access knowledge.
Measured: 12 weeks after randomization
Decision Self-Efficacy (Effectiveness outcome)
The change from baseline in decision self-efficacy as measured by the Decision Self-Efficacy Scale. The total score ranges from 0 to 11, with higher scores indicating a higher level of self-efficacy when making decisions about hemodialysis vascular access.
Measured: 12 weeks after randomization
Preparedness for Decision-Making (Effectiveness outcome)
A participant's level of preparedness for decision-making as measured by the Preparation for Decision-Making Scale. The total score ranges from 0-100, with higher scores indicating a higher perceived level of preparation for decision-making.
Measured: 12 weeks after randomization
Characteristics of Eligible Patients - quantitative reach assessment (Implementation outcome)
An assessment of the demographic and socioeconomic characteristics of patients who are eligible for the trial.
Measured: Pre-Enrollment
Characteristics of Enrolled Participants - quantitative reach assessment (Implementation outcome)
An assessment of the demographic and socioeconomic characteristics of patients who enroll in the trial.
Measured: Baseline
Characteristics of Participants who Complete the Trial - quantitative reach assessment (Implementation outcome)
An assessment of the demographic and socioeconomic characteristics of participants who complete the trial.
Measured: 12 months
Characteristics of Participants who Withdraw from the Trial - quantitative reach assessment (Implementation outcome)
An assessment of the demographic and socioeconomic characteristics of participants who withdraw from the trial.
Measured: From eligibility until 12 months
Declined Enrollment - quantitative reach assessment (Implementation outcome)
The reasons for declining enrollment as documented in screening logs and provided in aggregate for an enrolling center.
Measured: Pre-enrollment
Reasons for Participation - qualitative reach assessment (Implementation outcome)
The reasons for participation and non-participation as identified through qualitative interviews
Measured: 12-16 weeks after randomization
Reasons Nephrologists Opt-Out on Behalf of Patients - qualitative reach assessment (Implementation outcome)
The reasons that nephrologists opt out of having an eligible patient approached by the research team for possible enrollment as identified through qualitative interviews.
Measured: Up to 4 years after trial initiation (full duration of the trial)
Acceptability Intervention Measure - quantitative acceptability assessment (Implementation outcome)
The acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM). The total score ranges from 1-5, with higher scores indicating a higher level of acceptability of the intervention.
Measured: 12 -16 weeks after randomization
Acceptability of Intervention Content, Delivery, and Accessibility - qualitative acceptability assessment (Implementation outcome)
The acceptability of the content, delivery, and accessibility of educational materials and motivational interviewing coaching as identified through qualitative interviews.
Measured: 12 to 16 weeks after randomization
Chronic Kidney Disease Class Attendance - quantitative fidelity assessment (Implementation outcome)
The proportion of participants who attend a Chronic Kidney Disease education class provided by their nephrology clinic
Measured: Within 12 months
Receipt of Educational Materials - quantitative fidelity assessment (Implementation outcome)
The proportion of participants with confirmed receipt of the "Getting Ready" brochure (only be assessed for the Education and Education-Plus groups)
Measured: Within 12 weeks after randomization
Viewing of Video - quantitative fidelity assessment (Implementation outcome)
The proportion of participants with confirmed viewing of the "Getting Ready" video, which will only be assessed for the Education and Education-Plus groups.
Measured: Within 12 weeks after randomization
Completed Motivational Interviewing Sessions - quantitative fidelity assessment (Implementation outcome)
The proportion of participants who completed the scheduled motivational interviewing sessions (only be assessed for the Education-Plus group)
Measured: Within 12 months after randomization
Brochure Delivery Mode - quantitative barriers/facilitators assessment (Implementation outcome)
The selected mode for delivery of the "Getting Ready" brochure by center, clinic, and participant sociodemographic characteristics.
Measured: Within 12 weeks after randomization
Video Delivery Mode - quantitative barriers/facilitators assessment (Implementation outcome)
The selected mode for viewing of the "Getting Ready" video by center, clinic, and participant sociodemographic characteristics.
Measured: Within 12 weeks after randomization
Participant Contact Attempts for Motivational Interviewing - quantitative barriers/facilitators assessment (Implementation outcome)
The number and type (email, phone, text messaging) of attempted and confirmed participant contacts by the motivational interviewing coach.
Measured: 12 month period after randomization
Missed Motivational Interviewing Sessions - quantitative barriers/facilitators assessment (Implementation outcome)
The number of missed motivational interviewing sessions.
Measured: 12 month period after randomization
System-Level Barriers to Arteriovenous Access Creation From Clinical Staff Perspective - qualitative implementation/barriers assessment (Implementation outcome)
System-level barriers to arteriovenous vascular access creation and relevant system contextual factors as identified through qualitative interviews.
Measured: Up to 4 years after trial initiation (full duration of the trial)
System-Level Barriers to Arteriovenous Access Creation From Participant Perspective - qualitative implementation/barriers assessment (Implementation outcome)
System-level barriers to arteriovenous vascular access creation and relevant system contextual factors as identified through qualitative interviews.
Measured: Within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start5 Dec 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Dember, MD, University of Pennsylvania
- Investigators
- Laura M. Dember, MD, Principal investigator, University of PennsylvaniaJennifer E. Flythe, MD, MPH, Principal investigator, University of North Carolina, Chapel HillDeidra Crews, MD, ScM, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997875
- Sponsor's protocol ID
- 853978
- Acronym
- THRiVE
- Status last verified
- Mar 2026
- First submitted
- 19 Jul 2023
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Hemodialysis-Related Vascular Access Education (THRiVE)
- ClinicalTrials.gov ID
- NCT05997875
- Acronym / sponsor ID
- THRiVE / 853978
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Johns Hopkins University
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 18 Aug 2023 (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.
The focus of this study is on vascular access for hemodialysis. This is a randomized clinical trial testing 3 educational approaches to help patients with advanced chronic kidney disease prepare for placement of hemodialysis vascular access. Study participants will each be assigned to one of the 3 approaches: 1) "Education", in which participants will be given a video and brochure that provide information about the types of vascular access and what can be expected before and after the vascular access is placed, 2) "Education-Plus", in which participants will be given the video and brochure and will also have sessions by telehealth with a motivational interviewing coach to provide additional support around vascular access placement, and 3) "Usual Care", in which participants will have the usual education provided by their kidney doctor and clinic staff just as if they were not in the study. Participants in all 3 groups will be asked to complete questionnaires by telephone and may be invited to be interviewed about their experience with the study intervention at the end of the study. Study participation will last for about 12 months, with most of the study activities taking place during the first 3 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: Educational Materials, Behavioral: Usual Care, Other: Patient Lists for Clinicians: System-Level Intervention |
| Education-Plus | Experimental | Behavioral: Educational Materials, Behavioral: Motivational Interviewing, Behavioral: Usual Care, Other: Patient Lists for Clinicians: System-Level Intervention |
| Usual Care | Other | Behavioral: Usual Care, Other: Patient Lists for Clinicians: System-Level Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Nephrology visit for chronic kidney disease during the last 18 months
- Most recent eGFR less than or equal to 20 ml/min/1.73 m2 or 2-year Kidney Failure Risk Equation score greater than 40%
- Documentation in the medical record or confirmation from the treating nephrologist of a patient-nephrologist discussion about hemodialysis
Key exclusion criteria (5 listed)
- Planning for peritoneal dialysis, preemptive transplant, or conservative management of kidney failure
- Previous placement of an AV access
- Prior appointment with surgeon for AV access evaluation or creation
- Cognitive dysfunction or severe visual impairment that prevents use of the education materials
- Does not speak either English or Spanish
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 |
|---|---|---|
| Educational MaterialsParticipants are provided with the "Getting Ready: Your Vascular Access Journey" video and brochure about hemodialysis vascular access. The video is available for viewing via smartphone or computer. Both the brochure and video were created with input from patients with chronic kidney disease. | Behavioural | Education, Education-Plus |
| Motivational InterviewingParticipants receive coaching with telehealth-based motivational interviewing designed to prepare participants to move forward with vascular access creation. Motivational interviewing will consist of a minimum of 3 and maximum of 8 telehealth sessions with a coach. The coach will use patient-centered communication skills to work though the stages of pre-contemplative, contemplative, preparation, action, and maintenance of an arteriovenous vascular access. | Behavioural | Education-Plus |
| Usual CareParticipants receive the non-standardized vascular access counseling and referral to the chronic kidney disease education class that comprises the standard care provided by their nephrology clinic. | Behavioural | Education, Education-Plus, Usual Care |
| Patient Lists for Clinicians: System-Level InterventionNephrologists and clinic staff receive monthly, provider-specific, lists of patients potentially appropriate for AV access planning based on eGFR thresholds and kidney failure risk. These criteria identify patients at risk for progression to dialysis and are congruent with evidence-based guidelines for optimal timing of AV access evaluation referral. | Other | Education, Education-Plus, Usual Care |
Primary outcome
Surgery for Creation of Hemodialysis Arteriovenous Access (Effectiveness outcome)
Time frame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
The proportion of participants who have arteriovenous access creation surgery.
26 secondary outcomes
Scheduled Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome)
Time frame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
Completed Appointment with Surgeon for Vascular Access Evaluation (Effectiveness outcome)
Time frame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
Imaging for Planning Arteriovenous Vascular Access Creation (Effectiveness outcome)
Time frame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first
Usable Arteriovenous Vascular Access (Effectiveness outcome)
Time frame: Up to 4 years after randomization (full duration of the trial)
Vascular Access Knowledge (Effectiveness outcome)
Time frame: 12 weeks after randomization
Decision Self-Efficacy (Effectiveness outcome)
Time frame: 12 weeks after randomization
Preparedness for Decision-Making (Effectiveness outcome)
Time frame: 12 weeks after randomization
Characteristics of Eligible Patients - quantitative reach assessment (Implementation outcome)
Time frame: Pre-Enrollment
Characteristics of Enrolled Participants - quantitative reach assessment (Implementation outcome)
Time frame: Baseline
Characteristics of Participants who Complete the Trial - quantitative reach assessment (Implementation outcome)
Time frame: 12 months
Characteristics of Participants who Withdraw from the Trial - quantitative reach assessment (Implementation outcome)
Time frame: From eligibility until 12 months
Declined Enrollment - quantitative reach assessment (Implementation outcome)
Time frame: Pre-enrollment
Reasons for Participation - qualitative reach assessment (Implementation outcome)
Time frame: 12-16 weeks after randomization
Reasons Nephrologists Opt-Out on Behalf of Patients - qualitative reach assessment (Implementation outcome)
Time frame: Up to 4 years after trial initiation (full duration of the trial)
Acceptability Intervention Measure - quantitative acceptability assessment (Implementation outcome)
Time frame: 12 -16 weeks after randomization
Acceptability of Intervention Content, Delivery, and Accessibility - qualitative acceptability assessment (Implementation outcome)
Time frame: 12 to 16 weeks after randomization
Chronic Kidney Disease Class Attendance - quantitative fidelity assessment (Implementation outcome)
Time frame: Within 12 months
Receipt of Educational Materials - quantitative fidelity assessment (Implementation outcome)
Time frame: Within 12 weeks after randomization
Viewing of Video - quantitative fidelity assessment (Implementation outcome)
Time frame: Within 12 weeks after randomization
Completed Motivational Interviewing Sessions - quantitative fidelity assessment (Implementation outcome)
Time frame: Within 12 months after randomization
Brochure Delivery Mode - quantitative barriers/facilitators assessment (Implementation outcome)
Time frame: Within 12 weeks after randomization
Video Delivery Mode - quantitative barriers/facilitators assessment (Implementation outcome)
Time frame: Within 12 weeks after randomization
Participant Contact Attempts for Motivational Interviewing - quantitative barriers/facilitators assessment (Implementation outcome)
Time frame: 12 month period after randomization
Missed Motivational Interviewing Sessions - quantitative barriers/facilitators assessment (Implementation outcome)
Time frame: 12 month period after randomization
System-Level Barriers to Arteriovenous Access Creation From Clinical Staff Perspective - qualitative implementation/barriers assessment (Implementation outcome)
Time frame: Up to 4 years after trial initiation (full duration of the trial)
System-Level Barriers to Arteriovenous Access Creation From Participant Perspective - qualitative implementation/barriers assessment (Implementation outcome)
Time frame: Within 12 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 25 Mar 2026.
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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.
Laura M. Dember, MD principal investigator
University of Pennsylvania
Jennifer E. Flythe, MD, MPH principal investigator
University of North Carolina, Chapel Hill
Deidra Crews, MD, ScM principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Materials, Motivational Interviewing and Patient Lists for Clinicians: System-Level Intervention in people with Chronic Kidney Disease and Hemodialysis Vascular Access, run by University of Pennsylvania at 3 sites 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 4 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact Leah Bernardo (+1 215-746-4755, lleah@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery for Creation of Hemodialysis Arteriovenous Access (Effectiveness outcome) (time frame: Within 12 months after randomization or before hemodialysis initiation, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2026.