Chronic Kidney DiseasesNCT06411613
Home-based Conservative Care Model for Advanced Kidney Disease
A study testing CC Program in people with Chronic Kidney Diseases, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This is a randomized pilot study to test the feasibility and acceptability of a novel conservative care (CC) pathway among patients with advanced chronic kidney disease (CKD) who have chosen to forgo initiation of maintenance dialysis, their caregivers and providers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- CC Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2024to 6 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- Receives primary +/- nephrology care from VAPS as defined as having at least 1 outpatient primary or nephrology visit in the prior year
- Advanced CKD as defined as defined as having 2 or more outpatient measures of an eGFR 20 ml/min/1.73m2 separated by 90 or more days
- Unsure or do not wish to undergo maintenance dialysis
- Agreement by their VA primary +/- nephrology care provider that patients can participate in the study
- Caregivers:
Show all 10Show fewer
- Nominated by enrolled patient as a caregiver whom patient agrees to participate in the study
- Clinicians:
- Employed at VAPS
- Identified by enrolled Veterans as important to their CKD and nominated by the Veteran to be interviewed for the study
Who cannot join
- Patients:
- Unable to complete "teach-back" method of informed consent
- Currently receiving maintenance dialysis
- Currently enrolled in HBPC Program
- Caregivers:
- Unable to complete "teach-back" method of informed consent
Show all 9Show fewer
- If a Veteran withdraws from the study, their caregivers' participation in the study is also terminated at that time
- Clinicians:
- If a Veteran withdraws from the study, their clinicians will no longer be eligible to participate in interviews
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
About this study
This is a randomized pilot study to test the feasibility and acceptability of a novel conservative care (CC) pathway among patients with advanced chronic kidney disease (CKD) who have chosen to forgo initiation of maintenance dialysis, their caregivers and providers.
Read the detailed description
This study is a randomized pilot study to test the acceptability and feasibility of a CC pathway, called the Kidney Care at Home Program, with patients with advanced CKD who have chosen to forgo dialysis, their caregivers and providers. The novel CC program will be developed upon an existing home-based multidisciplinary care (MDC) program in the Veterans Affairs (VA) called the Home-Based Primary Care (HBPC) program. HBPC provides for Veterans with multimorbidity and functional limitation with the goal of supporting Veterans' quality of life and mitigating the complications of illness through to the end of life.
The investigators hypothesize that HBPC serves as the ideal starting ground to build the VA's first CC program for Veterans with advanced CKD. The investigators will use implementation science and ethnographic research methods, including field observations, interviews, medical record review, and serial structured surveys on quality of life, symptom burden, care satisfaction and goal concordant care to assess the feasibility and acceptability of the Kidney Care at Home Program (intervention) vs. usual care (control).
- Conditions
- Chronic Kidney Diseases
- Being tested
- CC Program
- Keywords
- CKD
- 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.
CC ProgramOther
The CC Program will be delivered through the existing HBPC infrastructure at VA Puget Sound Health Care System. Each HBPC team is comprised on a lead physician or nurse practitioner, nurse, pharmacist, nutritionist, social worker, psychologist, therapist, and chaplain. At a minimum, subsequent clinical encounters and assessments for each Veteran will be scheduled no less than on a quarterly basis and more often as needed based on the HBPC team's clinical judgment. On a monthly basis, the entire HBPC team will conduct MDC meetings to review each Veteran's medical plan. The Program aims to provide patient-centered, whole-person and team-based care, shared decision-making, active symptom management, advance care planning and end-of-life care.
| Study group | Role | What they receive |
|---|---|---|
| CC Program Received Intervention | Experimental | The CC Program will be delivered through the existing HBPC infrastructure at VA Puget Sound Health Care System. Each HBPC team is comprised on a lead physician or nurse practitioner, nurse, pharmacist, nutritionist, social worker, psychologist, therapist, and chaplain. At a minimum, subsequent clinical encounters and assessments for each Veteran will be scheduled no less than on a quarterly basis and more often as needed based on the HBPC team's clinical judgment. On a monthly basis, the entire HBPC team will conduct MDC meetings to review each Veteran's medical plan. The Program aims to provide patient-centered, whole-person and team-based care, shared decision-making, active symptom management, advance care planning and end-of-life care. Receives: Other: CC Program |
| Usual Care | No intervention | Does not receive intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Interviews
At each study visit, patients will be invited to complete a 45- to 60-minute interview to ascertain their experiences with and perspectives on their kidney care. Interviews will follow a structured guide intended to elicit: 1) benefits; 2) challenges; 3) unanticipated issues; and, 4) opportunities to improve respective approaches to care. Non-specific probes will be used to prompt subjects to elaborate on their responses for greater depth and detail. Veterans will be interviewed separately, in private, and in-person or by phone according to each person's preference. All interviews will be audio-recorded then transcribed without personal identifiers.
Measured: 1 year
Clinician Interviews
Clinicians will be invited to participate in up to two 30-minute structured interviews about their perception of their experiences with and perspectives on patients' kidney care.
Interviews will follow a structured guide similar to that for Veterans and caregivers.
Measured: 1 year
Field Observations
Patients will invite study staff to observe clinical encounters that they perceive as important to their kidney care.
These clinical encounters can include face-to-face, telephone, and video encounters. During the encounter, study staff will either digitally audio-record and/or note-take conversations and interactions or only observe and note-take after the encounter per each subject's preference. After the encounter is complete, we will ask subjects clarifying questions about the encounter as needed
Measured: 1 year
Document Review
Clinical progress notes entered into each patient's electronic medical record during the study period and abstract passages documenting care considerations regarding CKD.
Measured: 1 year
Caregiver Interviews
At each study visit caregivers of patients will be invited to complete a 45- to 60-minute interview to ascertain their experiences with and perspectives on the patient's kidney care.
Interviews will follow a structured guide intended to elicit: 1) benefits; 2) challenges; 3) unanticipated issues; and, 4) opportunities to improve respective approaches to care. Non-specific probes will be used to prompt subjects to elaborate on their responses for greater depth and detail. Caregivers will be interviewed separately, in private, and in-person or by phone according to each person's preference. All interviews will be audio-recorded then transcribed without personal identifiers.
Measured: 1 year
Secondary outcomes (8)
Health Outcomes Prioritization Scale
At each study visit, patients will be asked to rank their health priorities and whether they receive care that is aligned with their top priority using the Health Outcomes Prioritization Scale: priority score 0-100 of four universal health outcomes: keeping you alive, maintaining independence, reducing or eliminating pain, and reducing or eliminating other symptoms, with higher scores indicating that the outcome was more important.
Measured: 1 year
Zarit Burden Interview
At each study visit, caregivers will be asked about caregiver strain: a 12 item survey asking caregivers to rate the frequency with which they experience different forms of caregiver strain using the Zarit Burden Interview (4-point scale which describes degree of burden experienced from 0=never to 4=almost always).
Measured: 1 year
Consultation Satisfaction Questionnaire
At each study visit patients will be ask to rate their level of satisfaction with the care they receive using the Consultation Satisfaction Questionnaire. The Consultation Satisfaction Questionnaire is a 17-item survey utilizing Likert Scale responses: strongly disagree, somewhat disagree, neutral, somewhat agree, strongly agree, to assess overall care, professionalism, communication, time spent, and depth of the relationship with clinicians involved in their kidney care based on their last clinical visit.
Measured: 1 year
Edmonton Symptom Assessment Scale
At each study visit, patients will be asked about the presence and severity of common symptoms of advanced CKD using the Edmonton Symptom Assessment Scale (numeric rating scale 0=no symptoms to 10=worst possible).
Measured: 1 year
EQ-5D-5L
At each study visit, patients will be asked to rate different domains of their quality of life and overall health using the EuroQol 5D Questionnaire (EQ-5D-5L) to assess health-related quality of life. The EQ-5D-5L consists of two parts:
- EQ-5D Descriptive System: Includes Five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has five levels of severity ranging from no problems to extreme problems. The respondent indicates their health state by selecting the most appropriate level for each dimension.
- EQ Visual Analogue Scale (EQ-VAS): a scale where respondents rate their overall health from The worst health you can imagine (0) to the best health you can imagine (100).
Measured: 1 year
Non-Enrollment: Provider Did Not Agree to Recruitment of Veteran
The investigators will record reasons why eligible Veterans' primary care +/- nephrology provider did not agree to recruitment of Veterans to participate in the study.
Measured: 1 year
Non-Enrollment: Veteran Refusal to Participate
The investigators will record reasons for refusal to participate in the study by eligible Veterans.
Measured: 1 year
Attrition
The investigators will ask enrolled subjects who withdraw from the study their reasons for withdrawal.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start31 Jul 2024
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Why it stopped: Due to a budget deficit and hiring freeze, the intervention could not be implemented. Consequently, the study was modified from a pilot trial to an observational study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseasesStudies 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
- Model description
- Test the feasibility and acceptability of a novel care program
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ann M. O'Hare, MD MA, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411613
- Sponsor's protocol ID
- IIR 21-061
- Status last verified
- Sep 2025
- First submitted
- 29 Apr 2024
- Last updated
- 14 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified individual participant data collected and study protocols will be shared immediately following publication and ending 5 years following article publication with researchers who provide a written request and sound research proposal that has undergone human subjects review. Interested researchers can contact the principal investigator directly.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Conservative Care Model for Advanced Kidney Disease
- ClinicalTrials.gov ID
- NCT06411613
- Acronym / sponsor ID
- IIR 21-061
- Conditions
- Chronic Kidney Diseases
- Keywords
- CKD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to a budget deficit and hiring freeze, the intervention could not be implemented. Consequently, the study was modified from a pilot trial to an observational study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Posted 14 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized pilot study to test the feasibility and acceptability of a novel conservative care (CC) pathway among patients with advanced chronic kidney disease (CKD) who have chosen to forgo initiation of maintenance dialysis, their caregivers and providers.
Detailed description
This study is a randomized pilot study to test the acceptability and feasibility of a CC pathway, called the Kidney Care at Home Program, with patients with advanced CKD who have chosen to forgo dialysis, their caregivers and providers. The novel CC program will be developed upon an existing home-based multidisciplinary care (MDC) program in the Veterans Affairs (VA) called the Home-Based Primary Care (HBPC) program. HBPC provides for Veterans with multimorbidity and functional limitation with the goal of supporting Veterans' quality of life and mitigating the complications of illness through to the end of life.
The investigators hypothesize that HBPC serves as the ideal starting ground to build the VA's first CC program for Veterans with advanced CKD. The investigators will use implementation science and ethnographic research methods, including field observations, interviews, medical record review, and serial structured surveys on quality of life, symptom burden, care satisfaction and goal concordant care to assess the feasibility and acceptability of the Kidney Care at Home Program (intervention) vs. usual care (control).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Test the feasibility and acceptability of a novel care program
| Arm | Type | Receives |
|---|---|---|
| CC Program Received Intervention | Experimental | Other: CC ProgramThe CC Program will be delivered through the existing HBPC infrastructure at VA Puget Sound Health Care System. Each HBPC team is comprised on a lead physician or nurse practitioner, nurse, pharmacist, nutritionist, social worker, psychologist, therapist, and chaplain. At a minimum, subsequent clinical encounters and assessments for each Veteran will be scheduled no less than on a quarterly basis and more often as needed based on the HBPC team's clinical judgment. On a monthly basis, the entire HBPC team will conduct MDC meetings to review each Veteran's medical plan. The Program aims to provide patient-centered, whole-person and team-based care, shared decision-making, active symptom management, advance care planning and end-of-life care. |
| Usual Care | No intervention | –Does not receive intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Receives primary +/- nephrology care from VAPS as defined as having at least 1 outpatient primary or nephrology visit in the prior year
- Advanced CKD as defined as defined as having 2 or more outpatient measures of an eGFR 20 ml/min/1.73m2 separated by 90 or more days
- Unsure or do not wish to undergo maintenance dialysis
- Agreement by their VA primary +/- nephrology care provider that patients can participate in the study
- Nominated by enrolled patient as a caregiver whom patient agrees to participate in the study
Key exclusion criteria (9 listed)
- Unable to complete "teach-back" method of informed consent
- Currently receiving maintenance dialysis
- Currently enrolled in HBPC Program
- Unable to complete "teach-back" method of informed consent
- If a Veteran withdraws from the study, their caregivers' participation in the study is also terminated at that time
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 |
|---|---|---|
| CC ProgramThe CC Program will be delivered through the existing HBPC infrastructure at VA Puget Sound Health Care System. Each HBPC team is comprised on a lead physician or nurse practitioner, nurse, pharmacist, nutritionist, social worker, psychologist, therapist, and chaplain. At a minimum, subsequent clinical encounters and assessments for each Veteran will be scheduled no less than on a quarterly basis and more often as needed based on the HBPC team's clinical judgment. On a monthly basis, the entire HBPC team will conduct MDC meetings to review each Veteran's medical plan. The Program aims to provide patient-centered, whole-person and team-based care, shared decision-making, active symptom management, advance care planning and end-of-life care. | Other | CC Program Received Intervention |
Primary outcome
Patient Interviews
Time frame: 1 year
At each study visit, patients will be invited to complete a 45- to 60-minute interview to ascertain their experiences with and perspectives on their kidney care. Interviews will follow a structured guide intended to elicit: 1) benefits; 2) challenges; 3) unanticipated issues; and, 4) opportunities to improve respective approaches to care. Non-specific probes will be used to prompt subjects to elaborate on their responses for greater depth and detail. Veterans will be interviewed separately, in private, and in-person or by phone according to each person's preference. All interviews will be audio-recorded then transcribed without personal identifiers.
Clinician Interviews
Time frame: 1 year
Clinicians will be invited to participate in up to two 30-minute structured interviews about their perception of their experiences with and perspectives on patients' kidney care. Interviews will follow a structured guide similar to that for Veterans and caregivers.
Field Observations
Time frame: 1 year
Patients will invite study staff to observe clinical encounters that they perceive as important to their kidney care. These clinical encounters can include face-to-face, telephone, and video encounters. During the encounter, study staff will either digitally audio-record and/or note-take conversations and interactions or only observe and note-take after the encounter per each subject's preference. After the encounter is complete, we will ask subjects clarifying questions about the encounter as needed
Document Review
Time frame: 1 year
Clinical progress notes entered into each patient's electronic medical record during the study period and abstract passages documenting care considerations regarding CKD.
Caregiver Interviews
Time frame: 1 year
At each study visit caregivers of patients will be invited to complete a 45- to 60-minute interview to ascertain their experiences with and perspectives on the patient's kidney care. Interviews will follow a structured guide intended to elicit: 1) benefits; 2) challenges; 3) unanticipated issues; and, 4) opportunities to improve respective approaches to care. Non-specific probes will be used to prompt subjects to elaborate on their responses for greater depth and detail. Caregivers will be interviewed separately, in private, and in-person or by phone according to each person's preference. All interviews will be audio-recorded then transcribed without personal identifiers.
8 secondary outcomes
Health Outcomes Prioritization Scale
Time frame: 1 year
Zarit Burden Interview
Time frame: 1 year
Consultation Satisfaction Questionnaire
Time frame: 1 year
Edmonton Symptom Assessment Scale
Time frame: 1 year
EQ-5D-5L
Time frame: 1 year
Non-Enrollment: Provider Did Not Agree to Recruitment of Veteran
Time frame: 1 year
Non-Enrollment: Veteran Refusal to Participate
Time frame: 1 year
Attrition
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All de-identified individual participant data collected and study protocols will be shared immediately following publication and ending 5 years following article publication with researchers who provide a written request and sound research proposal that has undergone human subjects review. Interested researchers can contact the principal investigator directly.
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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.
Ann M. O'Hare, MD MA principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CC Program in people with Chronic Kidney Diseases, 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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 14 Oct 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?
Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Interviews (time frame: 1 year). The study lists 5 primary outcomes in all. 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 14 Oct 2025.