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Nurse-led help with symptoms for adults with advanced kidney disease

Tests a nurse-led symptom support programme in adults with advanced kidney disease and their caregivers.

Plain-language title generated from the registry record
Registry title: Feasibility of the COMFORT (COmplex Symptom Management Intervention FOR adulTs With Advanced Kidney Disease) Intervention for Adults With Advanced Kidney Disease and Their Informal Caregivers

Key facts

Where
Aarhus and Copenhagen, DenmarkSee the 2 sites

Where in Denmark

  • Aarhus University HospitalAarhus, DenmarkNo longer taking part
  • Rigshospitalet (Copenhagen University Hospital)Copenhagen, DenmarkNo longer taking part

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Trial details

Who runs it
University of Aarhus
Trial code
NCT07815639
Record updated
11 September 2026
Original description
The purpose of this randomized feasibility study is to examine whether the COMFORT intervention is feasible and acceptable for adults with advanced kidney disease and their informal caregivers.Read full original descriptionShow less

Feasibility of the COMFORT Intervention: A Randomised Feasibility Study of a Tailored Nurse-Led Symptom Management Intervention for Adults With Advanced Kidney Disease and Their Informal Caregivers

The purpose of this randomized feasibility study is to examine whether the COMFORT intervention is feasible and acceptable for adults with advanced kidney disease and their informal caregivers.

People with advanced kidney disease often experience several symptoms, such as fatigue, itching, pain, and sleep-related problems. These symptoms can affect daily life and quality of life and may also place a burden on family members and other informal caregivers. The COMFORT intervention is a nurse-led programme designed to help patients and their informal caregivers recognise and manage symptoms.

A total of 56 adults with advanced kidney disease will be randomly assigned to one of two groups. One group will receive usual care. The other group will receive usual care plus the COMFORT intervention over approximately 3 months. The intervention includes systematic assessment of symptoms, a symptom management decision-support tool, shared decision-making, support for self-management, and involvement and support of informal caregivers. It is delivered by trained nephrology nurses through two structured consultations and one follow-up telephone consultation.

The study will examine whether patients can be successfully recruited and retained, whether the intervention can be delivered as planned, whether patients, informal caregivers, and nurses find the intervention acceptable, and whether the study procedures and questionnaires are suitable for use in a future larger trial. The study is not designed to determine whether the COMFORT intervention is clinically effective.

Inclusion: Patients:; Age 18 years or older; Advanced kidney disease; At least one symptom with a score ≥2 on the Integrated Palliative care Outcome Scale-Renal (IPOS-Renal); Receiving haemodialysis, peritoneal dialysis, conservative kidney management, or predialysis care; Able to provide informed consent; Informal caregivers:; Age 18 years or older; Identified by a participating patient as an informal caregiver or close relative; Able to provide informed consent.

Exclusion: Severe psychiatric disorder; Informal caregivers:; Patients:; Unable to speak or read Danish; Unable to provide informed consent; Unable to complete study questionnaires; Unable to speak Danish; Unable to complete study questionnaires; Unable to provide informed consent.

ClinicalTrials.gov NCT07815639