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.
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
Unable to speak or read Danish
Unable to provide informed consent
Unable to complete study questionnaires
Severe psychiatric disorder
Parallel
COMFORT Intervention
BehavioralThe 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
Other interventionParticipants 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.
Recruitment Rate
Percentage of eligible patients approached for participation who provide informed consent and are enrolled in the feasibility study. The recruitment rate will be calculated as the number of enrolled patients divided by the number of eligible patients approached, multiplied by 100.
Participant Retention Rate at 3 Months
Percentage of enrolled patients who remain in the feasibility study and complete the 3-month follow-up assessment. The retention rate will be calculated as the number of enrolled patients completing the 3-month follow-up divided by the total number of enrolled patients, multiplied by 100.
Adherence to the COMFORT Intervention
Percentage of planned COMFORT intervention sessions attended by participants allocated to the intervention group. Adherence will be calculated as the number of intervention sessions attended divided by the number of planned intervention sessions, multiplied by 100. Scores range from 0% to 100%, with higher percentages indicating greater adherence.
Fidelity to the COMFORT Intervention
Percentage of prespecified COMFORT intervention components delivered as planned, assessed using session logs completed by the nephrology nurses delivering the intervention. Fidelity will be calculated as the number of intervention components delivered as planned divided by the number of applicable prespecified components, multiplied by 100. Scores range from 0% to 100%, with higher percentages indicating greater intervention fidelity.
Change From Baseline in Symptom Burden Assessed With the Integrated Palliative care Outcome Scale-Renal at 3 Months
Symptom burden will be assessed using the Integrated Palliative care Outcome Scale-Renal (IPOS-Renal). The IPOS-Renal total score ranges from 0 to 90, with higher scores indicating greater symptom burden and other health-related concerns. The outcome will be the change in total score from baseline to 3 months.
Change From Baseline in EuroQol 5-Dimension 3-Level Index Score at 3 Months
Health-related quality of life will be assessed using the EuroQol 5-Dimension 3-Level (EQ-5D-3L) questionnaire. Health states will be converted to an EQ-5D-3L index score using the Danish time trade-off value set. Index scores range from -0.624 to 1.000, with higher scores indicating better health-related quality of life. The outcome will be the change in index score from baseline to 3 months.
Change From Baseline in Fatigue Severity Scale Score at 3 Months
Fatigue will be assessed using the 9-item Fatigue Severity Scale (FSS). The total score ranges from 9 to 63, with higher scores indicating greater fatigue severity. The outcome will be the change in total score from baseline to 3 months.
Change From Baseline in Life Participation Assessed With Standardised Outcomes in Nephrology-Life Participation at 3 Months
Life participation will be assessed using the Standardised Outcomes in Nephrology-Life Participation (SONG-LP) instrument. The overall score ranges from 0 to 4 and is calculated as the mean of the available item scores. Higher scores indicate better life participation. The outcome will be the change in overall score from baseline to 3 months.
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