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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
Sponsor: University of Aarhus
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
112
Start Date
2026-09-15
Completion Date
2027-02
Last Updated
2026-09-11
Healthy Volunteers
No
Conditions
Interventions
COMFORT Intervention
The COMFORT intervention is a tailored, nurse-led symptom management intervention for adults with advanced kidney disease and their informal caregivers. It includes systematic symptom assessment using the Integrated Palliative care Outcome Scale-Renal (IPOS-Renal), an evidence-based symptom management decision-support tool, shared decision-making, self-management support, and caregiver involvement and support. The intervention is delivered by trained nephrology nurses over 12 weeks through two structured consultations and one follow-up telephone consultation, in addition to usual kidney care.
Usual Care
Participants receive usual kidney care according to standard clinical practice at the participating nephrology departments during the 12-week study period. Participants in this arm do not receive the COMFORT intervention.
Locations (2)
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Capital Region, Denmark
Aarhus University Hospital
Aarhus, Central Jutland, Denmark