Chronic Kidney Disease Stage 4ASKNCT07024953
The Agenda-Setting for Kidney Disease Trial
A study testing Chronic Kidney Disease Structured Agenda-Setting Tool in people with Chronic Kidney Disease Stage 4 and Chronic Kidney Disease Stage 5, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if a tool with a list of discussion topics, called a structured clinical visit agenda-setting intervention (SAS), works for people with advanced chronic kidney disease (CKD) who receive care at a clinic that serves people who live in rural areas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Stage 4, Chronic Kidney Disease Stage 5
- What is being tested?
- Chronic Kidney Disease Structured Agenda-Setting Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to Dec 2028
- 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
- Adults >18 years old who have been diagnosed with advanced CKD (stages 4-5).
- Care partners, clinicians and staff supporting these CKD patients who are willing and able to provide informed consent
- English-speaking
- Able to provide informed consent
- Patient must be attending outpatient visits *(in-person and/or telehealth allowable).
Who cannot join
- Children under 18 years old will not be included
- Non-English-speaking patients and/or care partners
- Patients on dialysis
- Individuals unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Catherine H. Saunders, Assistant Professor of Medicine and of Health Policy, PhD, MPH contact
Anne E. Dade, Research Associate, MPP contact
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
Official title: Setting the Agenda: A Pilot Stepped Wedge Cluster Randomized Trial of a Structured Clinical Visit Agenda-Setting Intervention for Rural-Residing People With Advanced Chronic Kidney Disease
The goal of this clinical trial is to learn if a tool with a list of discussion topics, called a structured clinical visit agenda-setting intervention (SAS), works for people with advanced chronic kidney disease (CKD) who receive care at a clinic that serves people who live in rural areas. The SAS is called CKD Topics. The researchers will compare the SAS intervention to usual care (the way clinicians usually practice) to see how well it works for people with advanced CKD. This is a special type of clinical trial called a stepped wedge randomized clinical trial (RCT). In this type of trial, every participant will get to experience both usual care and CKD Topics, but for different amounts of time.
The researchers will learn if doing a clinical trial of CKD Topics is possible (feasible) and get information about how well CKD Topics helps people with advanced CKD shape visit discussions (self-advocacy) in their appointments with their clinicians. The information the researchers collect in this trial will help design a future trial with more participants.
Read more
The main questions the researchers aim to answer are:
- Is it possible to conduct this type of study of a SAS intervention? i.e. feasibility
- Does the SAS intervention help people with advanced CKD shape discussions (self-advocacy) with their clinicians? If so, how much? i.e. preliminary efficacy
Read the detailed description
This stepped-wedge pilot randomized controlled trial (RCT) is to test a new structured agenda-setting (SAS), called the Chronic Kidney Disease (CKD) Topics Agenda-Setting Tool, with patients, their care partners and their clinicians. This is a pilot study, so the researchers are collecting feasibility data to determine if a larger, fully-powered RCT can be moved forward. The researchers are also collecting preliminary efficacy data, which will help the design of a future study on the efficacy of clinical visits for people with advanced CKD.
This study has two arms: 1) a usual care arm, and 2) an intervention arm where participants and their nephrology physicians will use CKD Topics during their visits. Physicians will initially be randomly assigned to one of three clusters, with two attending physicians and one fellow physician in each cluster. Each cluster will start out practicing usual care for at least eight months during the enrollment period. After that initial 8 months, one cluster will cross over to the intervention arm every four months, by using the CKD Topics tool in their visits, in what's called the rollout period. At 16 months into the trial, all clusters will be on the intervention arm, using CKD topics with patients, and will do so for the remaining 12 months of the trial.
Patient participants will be enrolled in the study arm to which their physicians have been randomized. Participation is expected to last 24 months for patients and clinicians, and participants may use CKD Topics more than once during the study period. The researchers expect 108 patient participants, and nine clinicians will enroll in the study. Every participant will receive a baseline survey after enrollment and four subsequent surveys.
The procedures in this study will include screening patients for study eligibility, consenting them to participate in study activities such as filling out surveys. The intervention, CKD topics, itself will be administered as quality improvement so will not be included as a research activity needing consent.
Future Directions: Findings from this trial will forecast a range of participants required in the sample for a full-scale RCT and illustrate "proof of concept" for a future trial which will evaluate the intervention's impact on patient self-advocacy and clinical care outcomes in rural CKD populations.
- Being tested
- Chronic Kidney Disease Structured Agenda-Setting Tool
- Keywords
- Chronic Kidney Disease, Chronic kidney disease stage 4, Chronic kidney disease stage 5, Agenda-setting, Rural, Patient engagement, Randomized trial, Participatory research
- Medical subject headings
- Renal Insufficiency, Chronic, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Kidney Disease Structured Agenda-Setting ToolOther
Chronic Kidney Disease (CKD) Topics is a novel clinical visit agenda-setting intervention developed through participatory research methods for people with CKD living in rural areas. CKD Topics includes structured discussion topic areas.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 is Usual Care | No intervention | The clinicians in the nephrology clinic will proceed with usual care without intervention from the study team. |
| Arm 2 is Clinical Visit Agenda Setting Tool Intervention | Experimental | The study team will implement a structured clinical visit agenda-setting (SAS) intervention customized for advanced chronic kidney disease, called Chronic Kidney Disease (CKD) Topics. Receives: Other: Chronic Kidney Disease Structured Agenda-Setting Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Feasibility Outcome
The primary outcome will be feasibility, assessed by the proportion of patients who received the intervention.
Measured: From enrollment to the end of treatment at 16 months
Secondary outcomes (1)
Secondary Feasibility Outcome
The secondary outcome will be feasibility assessed by the clinicians' intention to continue the intervention use, measured in a survey.
Measured: From enrollment to the end of treatment at 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Sep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Stage 4Studies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Crossover
- Model description
- Stepped wedge randomized controlled trial with clustered cross-over assignment
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College, University of Washington, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Catherine Hylas Saunders, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024953
- Sponsor's protocol ID
- STUDY02002598_1
- Other IDs
- 1K01DK139400
- Acronym
- ASK
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will use standard processing and documentation protocols adopted by the Inter-university Consortium for Political and Social Research (ICPSR) for data formats, dictionaries, variable names, descriptions, and labels. An XML schema using Data Documenting Initiative standards will also be used for codebooks and other metadata as appropriate. The researchers will share RCT process and outcomes data in CSV files via openICPSR, which is a self-publishing repository for social, behavioral and health science data and part of the ICPSR.
Publications
Brashers DE, Haas SM, Neidig JL. The patient self-advocacy scale: measuring patient involvement in health care decision-making interactions. Health Commun. 1999;11(2):97-121. doi: 10.1207/s15327027hc1102_1.
PubMed 16370972Clayman ML, Pandit AU, Bergeron AR, Cameron KA, Ross E, Wolf MS. Ask, understand, remember: a brief measure of patient communication self-efficacy within clinical encounters. J Health Commun. 2010;15 Suppl 2(Suppl 2):72-9. doi: 10.1080/10810730.2010.500349.
PubMed 20845194Frankel RM, Salyers MP, Bonfils KA, Oles SK, Matthias MS. Agenda setting in psychiatric consultations: an exploratory study. Psychiatr Rehabil J. 2013 Sep;36(3):195-201. doi: 10.1037/prj0000004. Epub 2013 Jul 1.
PubMed 23815174Gramling R, Stanek S, Ladwig S, Gajary-Coots E, Cimino J, Anderson W, Norton SA; AAHPM Research Committee Writing Group; Aslakson RA, Ast K, Elk R, Garner KK, Gramling R, Grudzen C, Kamal AH, Lamba S, LeBlanc TW, Rhodes RL, Roeland E, Schulman-Green D, Unroe KT. Feeling Heard and Understood: A Patient-Reported Quality Measure for the Inpatient Palliative Care Setting. J Pain Symptom Manage. 2016 Feb;51(2):150-4. doi: 10.1016/j.jpainsymman.2015.10.018. Epub 2015 Nov 17.
PubMed 26596879Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015 Feb 6;350:h391. doi: 10.1136/bmj.h391. No abstract available.
PubMed 25662947Makoul G, Krupat E, Chang CH. Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool. Patient Educ Couns. 2007 Aug;67(3):333-42. doi: 10.1016/j.pec.2007.05.005. Epub 2007 Jun 18.
PubMed 17574367Saunders CH, Durand MA, Kirkland KB, MacMartin MA, Barnato AE, Elwyn G. Psychometric assessment of the consideRATE questions, a new measure of serious illness experience, with an online simulation study. Patient Educ Couns. 2022 Jul;105(7):2581-2589. doi: 10.1016/j.pec.2022.01.002. Epub 2022 Jan 22.
PubMed 35260261Saunders CH, Durand MA, Scalia P, Kirkland KB, MacMartin MA, Barnato AE, Milne DW, Collison J, Bennett A, Wasp G, Nelson E, Elwyn G. "It helps us say what's important..." Developing Serious Illness Topics: A clinical visit agenda-setting tool. Patient Educ Couns. 2023 Aug;113:107764. doi: 10.1016/j.pec.2023.107764. Epub 2023 Apr 18.
PubMed 37150152Saunders CH, Durand MA, Scalia P, Kirkland KB, MacMartin MA, Barnato AE, Milne DW, Collison J, Jaggars A, Butt T, Wasp G, Nelson E, Elwyn G. User-Centered Design of the consideRATE Questions, a Measure of People's Experiences When They Are Seriously Ill. J Pain Symptom Manage. 2021 Mar;61(3):555-565.e5. doi: 10.1016/j.jpainsymman.2020.08.002. Epub 2020 Aug 16.
PubMed 32814165Sierpe A, Yen RW, Stevens G, Van Citters AD, Elwyn G, Saunders CH. Agenda-setting in the clinical encounter: A systematic review protocol. PLoS One. 2024 Oct 24;19(10):e0312613. doi: 10.1371/journal.pone.0312613. eCollection 2024.
PubMed 39446854Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Wild MG, Wallston KA, Green JA, Beach LB, Umeukeje E, Wright Nunes JA, Ikizler TA, Steed J, Cavanaugh KL. The Perceived Medical Condition Self-Management Scale can be applied to patients with chronic kidney disease. Kidney Int. 2017 Oct;92(4):972-978. doi: 10.1016/j.kint.2017.03.018. Epub 2017 May 18.
PubMed 28528132
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Setting the Agenda: A Pilot Stepped Wedge Cluster Randomized Trial of a Structured Clinical Visit Agenda-Setting Intervention for Rural-Residing People With Advanced Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07024953
- Acronym / sponsor ID
- ASK / STUDY02002598_1
- Keywords
- Chronic Kidney Disease, Chronic kidney disease stage 4, Chronic kidney disease stage 5, Agenda-setting, Rural, Patient engagement, Randomized trial, Participatory research
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth College, University of Washington, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Jun 2025 (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 goal of this clinical trial is to learn if a tool with a list of discussion topics, called a structured clinical visit agenda-setting intervention (SAS), works for people with advanced chronic kidney disease (CKD) who receive care at a clinic that serves people who live in rural areas. The SAS is called CKD Topics. The researchers will compare the SAS intervention to usual care (the way clinicians usually practice) to see how well it works for people with advanced CKD. This is a special type of clinical trial called a stepped wedge randomized clinical trial (RCT). In this type of trial, every participant will get to experience both usual care and CKD Topics, but for different amounts of time.
The researchers will learn if doing a clinical trial of CKD Topics is possible (feasible) and get information about how well CKD Topics helps people with advanced CKD shape visit discussions (self-advocacy) in their appointments with their clinicians. The information the researchers collect in this trial will help design a future trial with more participants.
The main questions the researchers aim to answer are:
- Is it possible to conduct this type of study of a SAS intervention? i.e. feasibility
- Does the SAS intervention help people with advanced CKD shape discussions (self-advocacy) with their clinicians? If so, how much? i.e. preliminary efficacy
Detailed description
This stepped-wedge pilot randomized controlled trial (RCT) is to test a new structured agenda-setting (SAS), called the Chronic Kidney Disease (CKD) Topics Agenda-Setting Tool, with patients, their care partners and their clinicians. This is a pilot study, so the researchers are collecting feasibility data to determine if a larger, fully-powered RCT can be moved forward. The researchers are also collecting preliminary efficacy data, which will help the design of a future study on the efficacy of clinical visits for people with advanced CKD.
This study has two arms: 1) a usual care arm, and 2) an intervention arm where participants and their nephrology physicians will use CKD Topics during their visits. Physicians will initially be randomly assigned to one of three clusters, with two attending physicians and one fellow physician in each cluster. Each cluster will start out practicing usual care for at least eight months during the enrollment period. After that initial 8 months, one cluster will cross over to the intervention arm every four months, by using the CKD Topics tool in their visits, in what's called the rollout period. At 16 months into the trial, all clusters will be on the intervention arm, using CKD topics with patients, and will do so for the remaining 12 months of the trial.
Patient participants will be enrolled in the study arm to which their physicians have been randomized. Participation is expected to last 24 months for patients and clinicians, and participants may use CKD Topics more than once during the study period. The researchers expect 108 patient participants, and nine clinicians will enroll in the study. Every participant will receive a baseline survey after enrollment and four subsequent surveys.
The procedures in this study will include screening patients for study eligibility, consenting them to participate in study activities such as filling out surveys. The intervention, CKD topics, itself will be administered as quality improvement so will not be included as a research activity needing consent.
Future Directions: Findings from this trial will forecast a range of participants required in the sample for a full-scale RCT and illustrate "proof of concept" for a future trial which will evaluate the intervention's impact on patient self-advocacy and clinical care outcomes in rural CKD populations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge randomized controlled trial with clustered cross-over assignment
| Arm | Type | Receives |
|---|---|---|
| Arm 1 is Usual Care | No intervention | –The clinicians in the nephrology clinic will proceed with usual care without intervention from the study team. |
| Arm 2 is Clinical Visit Agenda Setting Tool Intervention | Experimental | Other: Chronic Kidney Disease Structured Agenda-Setting ToolThe study team will implement a structured clinical visit agenda-setting (SAS) intervention customized for advanced chronic kidney disease, called Chronic Kidney Disease (CKD) Topics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults >18 years old who have been diagnosed with advanced CKD (stages 4-5).
- Care partners, clinicians and staff supporting these CKD patients who are willing and able to provide informed consent
- English-speaking
- Able to provide informed consent
- Patient must be attending outpatient visits *(in-person and/or telehealth allowable).
Key exclusion criteria (4 listed)
- Children under 18 years old will not be included
- Non-English-speaking patients and/or care partners
- Patients on dialysis
- Individuals unable or unwilling to provide informed consent
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 |
|---|---|---|
| Chronic Kidney Disease Structured Agenda-Setting ToolChronic Kidney Disease (CKD) Topics is a novel clinical visit agenda-setting intervention developed through participatory research methods for people with CKD living in rural areas. CKD Topics includes structured discussion topic areas. | Other | Arm 2 is Clinical Visit Agenda Setting Tool Intervention |
Primary outcome
Primary Feasibility Outcome
Time frame: From enrollment to the end of treatment at 16 months
The primary outcome will be feasibility, assessed by the proportion of patients who received the intervention.
1 secondary outcome
Secondary Feasibility Outcome
Time frame: From enrollment to the end of treatment at 16 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 24 Jun 2025.
- Background: PubMed 16370972Brashers DE, Haas SM, Neidig JL. The patient self-advocacy scale: measuring patient involvement in health care decision-making interactions. Health Commun. 1999;11(2):97-121. doi: 10.1207/s15327027hc1102_1.
- Background: PubMed 20845194Clayman ML, Pandit AU, Bergeron AR, Cameron KA, Ross E, Wolf MS. Ask, understand, remember: a brief measure of patient communication self-efficacy within clinical encounters. J Health Commun. 2010;15 Suppl 2(Suppl 2):72-9. doi: 10.1080/10810730.2010.500349.
- Background: PubMed 23815174Frankel RM, Salyers MP, Bonfils KA, Oles SK, Matthias MS. Agenda setting in psychiatric consultations: an exploratory study. Psychiatr Rehabil J. 2013 Sep;36(3):195-201. doi: 10.1037/prj0000004. Epub 2013 Jul 1.
- Background: PubMed 26596879Gramling R, Stanek S, Ladwig S, Gajary-Coots E, Cimino J, Anderson W, Norton SA; AAHPM Research Committee Writing Group; Aslakson RA, Ast K, Elk R, Garner KK, Gramling R, Grudzen C, Kamal AH, Lamba S, LeBlanc TW, Rhodes RL, Roeland E, Schulman-Green D, Unroe KT. Feeling Heard and Understood: A Patient-Reported Quality Measure for the Inpatient Palliative Care Setting. J Pain Symptom Manage. 2016 Feb;51(2):150-4. doi: 10.1016/j.jpainsymman.2015.10.018. Epub 2015 Nov 17.
- Background: PubMed 25662947Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015 Feb 6;350:h391. doi: 10.1136/bmj.h391. No abstract available.
- Background: PubMed 17574367Makoul G, Krupat E, Chang CH. Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool. Patient Educ Couns. 2007 Aug;67(3):333-42. doi: 10.1016/j.pec.2007.05.005. Epub 2007 Jun 18.
- Background: PubMed 35260261Saunders CH, Durand MA, Kirkland KB, MacMartin MA, Barnato AE, Elwyn G. Psychometric assessment of the consideRATE questions, a new measure of serious illness experience, with an online simulation study. Patient Educ Couns. 2022 Jul;105(7):2581-2589. doi: 10.1016/j.pec.2022.01.002. Epub 2022 Jan 22.
- Background: PubMed 37150152Saunders CH, Durand MA, Scalia P, Kirkland KB, MacMartin MA, Barnato AE, Milne DW, Collison J, Bennett A, Wasp G, Nelson E, Elwyn G. "It helps us say what's important..." Developing Serious Illness Topics: A clinical visit agenda-setting tool. Patient Educ Couns. 2023 Aug;113:107764. doi: 10.1016/j.pec.2023.107764. Epub 2023 Apr 18.
- Background: PubMed 32814165Saunders CH, Durand MA, Scalia P, Kirkland KB, MacMartin MA, Barnato AE, Milne DW, Collison J, Jaggars A, Butt T, Wasp G, Nelson E, Elwyn G. User-Centered Design of the consideRATE Questions, a Measure of People's Experiences When They Are Seriously Ill. J Pain Symptom Manage. 2021 Mar;61(3):555-565.e5. doi: 10.1016/j.jpainsymman.2020.08.002. Epub 2020 Aug 16.
- Background: PubMed 39446854Sierpe A, Yen RW, Stevens G, Van Citters AD, Elwyn G, Saunders CH. Agenda-setting in the clinical encounter: A systematic review protocol. PLoS One. 2024 Oct 24;19(10):e0312613. doi: 10.1371/journal.pone.0312613. eCollection 2024.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 28528132Wild MG, Wallston KA, Green JA, Beach LB, Umeukeje E, Wright Nunes JA, Ikizler TA, Steed J, Cavanaugh KL. The Perceived Medical Condition Self-Management Scale can be applied to patients with chronic kidney disease. Kidney Int. 2017 Oct;92(4):972-978. doi: 10.1016/j.kint.2017.03.018. Epub 2017 May 18.
- Individual participant dataSharing planned: No. The study will use standard processing and documentation protocols adopted by the Inter-university Consortium for Political and Social Research (ICPSR) for data formats, dictionaries, variable names, descriptions, and labels. An XML schema using Data Documenting Initiative standards will also be used for codebooks and other metadata as appropriate. The researchers will share RCT process and outcomes data in CSV files via openICPSR, which is a self-publishing repository for social, behavioral and health science data and part of the ICPSR.
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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.
Catherine H. Saunders, Assistant Professor of Medicine and of Health Policy, PhD, MPH contact
Anne E. Dade, Research Associate, MPP contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chronic Kidney Disease Structured Agenda-Setting Tool in people with Chronic Kidney Disease Stage 4 and Chronic Kidney Disease Stage 5, run by Dartmouth-Hitchcock Medical Center 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 24 Jun 2025. 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?
Contact Catherine H. Saunders, Assistant Professor of Medicine and of Health Policy, PhD, MPH (603-653-3436, Catherine.Hylas.Saunders@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Feasibility Outcome (time frame: From enrollment to the end of treatment at 16 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 NCT07024953, which also lists 12 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 24 Jun 2025.