Chronic Kidney Disease, Stage 4 (Severe)PEACENCT06819345
Impact of PREMs in the Shared Decision Process for Renal Replacement Treatment Methods.
An observational study of Chronic Kidney Disease, Stage 4 (Severe) and Chronic Kidney Disease, Stage 5, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The French "my health 2022" plan is the first bundled payment initiative for stage 4 and 5 chronic kidney disease (CKD) pathway with the aim to improve the quality of care and promote a multi professional collaboration for a more holistic approach of healthcare. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Stage 4 (Severe), Chronic Kidney Disease, Stage 5
- What is being tested?
- Survey form
- Type of treatment
- Pill or oral medicine
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2025to 1 Jan 2028
- Phase
- Observational
- 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
Study population: Patients will be selected from the CKD patients cohort followed at the nephrology department Hôpital Edouard Herriot with at least 3 months of follow up at the department and referred to the consultation for renal replacement therapies information.
Who may be able to join
- Patients
- Stage 4-5 chronic kidney disease not on dialysis with a nephrologist follow up >3 months
- Glomerular filtration rate estimated by the CKD EPI formula < 20 ml/min/1.73 m2,
- Referred for consultation and information on renal replacement therapies.
- Age >18 years old.
- Patient with a sufficient level of oral comprehension of French, able to understand the research
Who cannot join
- significant cognitive disorders preventing decision making
- patients under guardianship, or legal protection
- referred for ultrafiltration in the context of cardio renal syndrome
Trial locations and contacts
1 site in 1 country.
France1 site
Nephrology, Hypertension, dialysis department of Edouard Herriot hospital
Lyon, 69003
About this study
Official title: Patients and Health Providers Experience and Choice of Treatment in End Stage Renal Disease
The French "my health 2022" plan is the first bundled payment initiative for stage 4 and 5 chronic kidney disease (CKD) pathway with the aim to improve the quality of care and promote a multi professional collaboration for a more holistic approach of healthcare. Renal Replacement therapies (RRT) have a significant impact on the quality of life and autonomy of patients and their caregivers. The transition to these treatments is a critical point in the pathway, involving a complex choice for patients that cannot be based solely on medical considerations but requires to assess the needs and preferences of patients and their caregivers in order to improve their experience and the quality of care. The investigators propose to conduct a prospective cohort study aimed at 1/ describing the patient and caregiver experience, patient related outcome measures (PROM) and the quality of life in relation to the decision-making process 2/ identifying the individual factors (socio-cultural, health literacy) associated with the patient experience, 3/ assessing the expectations and needs of patients regarding the information and support received during the process, and 4/ describing the perceptions of caregivers and professionals regarding the information provided and the decision-making process. The assessments will be conducted by questionnaires before, 3 months after the information on RRT and 3 months after the initiation of RRT or 24 months after the initial information for patients and caregivers and at the time of information on RRT for professionals. The data from the questionnaires will be further explored by a qualitative survey in a subgroup of patients and caregivers. The results of this study will help identify the factors determining the choice and satisfaction of patients and their caregivers in order to adapt the decision making support and thus have a patient-centered approach.
- Being tested
- Survey form
- Keywords
- Chronic kidney disease, renal replacement therapy,, caregivers, PREM, PROM, shared decision making
- 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.
Survey formOther
PPE15 (Picker Patient Experience Questionnaire) at all visit of the study KDQOL-SF (Kidney Disease Quality Of Life -short form) at inclusion and 3 months after initiation of RRT ou 24 months after inclusion SDMQ9 (Shared Decision Making Questionnaire): at inclusion and 3 months after receiving information related to RRT SDRS (Score Decision Regret Scale) : 3 months after initiation of RRT ou 24 months after inclusion HLS EU 16 (Health Literacy Survey) : at inclusion or 3 months after information on RRT
| Study group | Role | What they receive |
|---|---|---|
| Patients | -Patients with chronic renal disease stage 4-5 not on dialysis followed by a nephrologist for at least three months. Receives: Other: Survey form | |
| Caregivers | First non-professional natural caregiver identified by the patient for all voluntary caregivers.
- Caregiver with a sufficient level of oral comprehension of French, able to understand the research Receives: Other: Survey form | |
| Health professionals | Nephrologists and nurses or other health professionals caring for patients included in the study. Receives: Other: Survey form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient related experience measure (PREM)
The main objective is to describe and monitor the evolution of the chronic renal failure patient experience during the decision-making process regarding renal replacement therapies (PD, HD or transplantation).
Using the questionnaire : Picker Patient Experience PPE15
Measured: 3 months after the announcement of stage V renal failure during the usual follow-up nephrology consultation And 3 months after the start of renal replacement therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease, Stage 4 (Severe)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819345
- Sponsor's protocol ID
- 908
- Acronym
- PEACE
- Status last verified
- Jan 2025
- First submitted
- 5 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients and Health Providers Experience and Choice of Treatment in End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT06819345
- Acronym / sponsor ID
- PEACE / 908
- Keywords
- Chronic kidney disease, renal replacement therapy,, caregivers, PREM, PROM, shared decision making
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 11 Feb 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 French "my health 2022" plan is the first bundled payment initiative for stage 4 and 5 chronic kidney disease (CKD) pathway with the aim to improve the quality of care and promote a multi professional collaboration for a more holistic approach of healthcare. Renal Replacement therapies (RRT) have a significant impact on the quality of life and autonomy of patients and their caregivers. The transition to these treatments is a critical point in the pathway, involving a complex choice for patients that cannot be based solely on medical considerations but requires to assess the needs and preferences of patients and their caregivers in order to improve their experience and the quality of care. The investigators propose to conduct a prospective cohort study aimed at 1/ describing the patient and caregiver experience, patient related outcome measures (PROM) and the quality of life in relation to the decision-making process 2/ identifying the individual factors (socio-cultural, health literacy) associated with the patient experience, 3/ assessing the expectations and needs of patients regarding the information and support received during the process, and 4/ describing the perceptions of caregivers and professionals regarding the information provided and the decision-making process. The assessments will be conducted by questionnaires before, 3 months after the information on RRT and 3 months after the initiation of RRT or 24 months after the initial information for patients and caregivers and at the time of information on RRT for professionals. The data from the questionnaires will be further explored by a qualitative survey in a subgroup of patients and caregivers. The results of this study will help identify the factors determining the choice and satisfaction of patients and their caregivers in order to adapt the decision making support and thus have a patient-centered approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Survey form-Patients with chronic renal disease stage 4-5 not on dialysis followed by a nephrologist for at least three months. |
| Caregivers | – | Other: Survey formFirst non-professional natural caregiver identified by the patient for all voluntary caregivers. - Caregiver with a sufficient level of oral comprehension of French, able to understand the research |
| Health professionals | – | Other: Survey formNephrologists and nurses or other health professionals caring for patients included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from the CKD patients cohort followed at the nephrology department Hôpital Edouard Herriot with at least 3 months of follow up at the department and referred to the consultation for renal replacement therapies information.
Key inclusion criteria (6 listed)
- Patients
- Stage 4-5 chronic kidney disease not on dialysis with a nephrologist follow up >3 months
- Glomerular filtration rate estimated by the CKD EPI formula < 20 ml/min/1.73 m2,
- Referred for consultation and information on renal replacement therapies.
- Age >18 years old.
Key exclusion criteria (3 listed)
- significant cognitive disorders preventing decision making
- patients under guardianship, or legal protection
- referred for ultrafiltration in the context of cardio renal syndrome
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 |
|---|---|---|
| Survey formPPE15 (Picker Patient Experience Questionnaire) at all visit of the study KDQOL-SF (Kidney Disease Quality Of Life -short form) at inclusion and 3 months after initiation of RRT ou 24 months after inclusion SDMQ9 (Shared Decision Making Questionnaire): at inclusion and 3 months after receiving information related to RRT SDRS (Score Decision Regret Scale) : 3 months after initiation of RRT ou 24 months after inclusion HLS EU 16 (Health Literacy Survey) : at inclusion or 3 months after information on RRT | Other | Caregivers, Health professionals, Patients |
Primary outcome
Patient related experience measure (PREM)
Time frame: 3 months after the announcement of stage V renal failure during the usual follow-up nephrology consultation And 3 months after the start of renal replacement therapy
The main objective is to describe and monitor the evolution of the chronic renal failure patient experience during the decision-making process regarding renal replacement therapies (PD, HD or transplantation). Using the questionnaire : Picker Patient Experience PPE15
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 11 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, Stage 4 (Severe) and Chronic Kidney Disease, Stage 5, run by Hospices Civils de Lyon at 1 site in France.
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 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Feb 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 France. 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?
Patient related experience measure (PREM) (time frame: 3 months after the announcement of stage V renal failure during the usual follow-up nephrology consultation And 3 months after the start of renal replacement therapy). 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 11 Feb 2025.