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NCT06819345Active, not recruiting

Impact of PREMs in the Shared Decision Process for Renal Replacement Treatment Methods.

Patients and Health Providers Experience and Choice of Treatment in End Stage Renal Disease

Source: ClinicalTrials.gov · Last updated 11 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
70 (estimated)
First submitted
5 Feb 2025
Start date
1 Jan 2025
Primary completion date
1 Jan 2028
Lead sponsor
Hospices Civils de Lyon
NCT number
NCT06819345

What you commit to

  • Study type: Observational
  • Planned participants: 70
  • From 1 Jan 2025 to the primary completion date, 1 Jan 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • significant cognitive disorders preventing decision making
  • referred for ultrafiltration in the context of cardio renal syndrome

Other

  • patients under guardianship, or legal protection

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nephrology, Hypertension, dialysis department of Edouard Herriot hospital
Coordinator of this site? Confirm its status
LyonFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.