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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05842772
Other study ID # PilotRCT_LEB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 20, 2023
Est. completion date October 6, 2023

Study information

Verified date February 2023
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this research is to test the acceptability and feasibility of a shared decision making intervention and a patient decision aid to support patients with kidney failure, relatives, and health professionals in planning and deciding about end-of-life care together.


Description:

The objectives of this study is to pilot test an intervention aiming to accomplish shared decision making when deciding about end-of-life care preferences in people with kidney failure. The intervention consists of shared decision making consultations for adults with kidney failure their relatives and contact health professionals regarding end-of-life care planning supported by a patient decision aid. We will evaluate how adults, relatives and, health professionals implements the intervention and if the intervention is acceptable to the different stakeholders. The research question will investigate if the adults, relatives, and health professionals are experiencing the intervention as shared decision making and if they feel involved in the decision making process. The DESIRE trial is designed as a pragmatic, pilot, randomized, controlled, non-blinded multicenter superiority trial with two parallel groups will test the acceptability and feasibility of the intervention on patients, relatives, and health professionals. Randomization will be performed as block randomization with a 1:1 allocation.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date October 6, 2023
Est. primary completion date October 6, 2023
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - Adults with kidney failure on haemodialysis, peritoneal dialysis, or on conservative kidney management and their relatives will be considered for participation. Inclusion criteria will be adults =75 years of age, with an estimated glomerular filtration rate <15, and not suited for a kidney transplant. Exclusion Criteria: - Adults who are cognitively unable to participate will be excluded from the research.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Shared decision making intervention for patients with kidney failure when planning end-of-life care
Testing a shared decision making intervention and a patient decision aid for patients with kidney failure, their relatives, and the health professionals.

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in the patient's palliative care needs The primary outcome will be the change in the adults' palliative needs, as measured using the Integrated Palliative Outcome Score (IPOS)-Renal patient version questionnaire Through study completion, an average of 6 months
Secondary Participants and relatives' experiences of shared decision making and health professionals' conduction of shared decision making are secondary outcomes. Participants and relatives' experiences of shared decision making, as measured using the Patient Experience of Shared Decision Making (SHARED) tool and healthprofessionals' conduction of shared decision making, as measured using the Decision Support Analysis Tool (DSAT-10) are secondary outcomes. Through study completion, an average of 6 months
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