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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Recruitment Rate — Baseline and 3 months
  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 — 3 months after enrolment
  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 — Baseline and 3 months
  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 — Baseline and 3 months
  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.
• Completeness of Questionnaire Data — Baseline and 3 months
  Percentage of expected questionnaire data that are completed at the planned assessment time points. Data completeness will be calculated as the number of completed questionnaire data fields divided by the total number of expected questionnaire data fields, multiplied by 100. Scores range from 0% to 100%, with higher percentages indicating greater data completeness.
• Acceptability of the COMFORT Intervention Assessed by Qualitative Interviews — At 3 months
  Acceptability of the COMFORT intervention will be explored through qualitative interviews with participating patients, informal caregivers, and nephrology nurses. Interview data will be analysed qualitatively to identify themes specifically related to experiences of and acceptability of the intervention.
• Perceived Relevance of the COMFORT Intervention Assessed by Qualitative Interviews — At 3 months
  Perceived relevance of the COMFORT intervention will be explored through qualitative interviews with participating patients and informal caregivers. Interview data will be analysed qualitatively to identify themes specifically related to the perceived relevance of the intervention.
• Perceived Feasibility of the COMFORT Intervention Assessed by Qualitative Interviews — At 3 months
  Perceived feasibility of the COMFORT intervention will be explored through qualitative interviews with participating patients, informal caregivers, and nephrology nurses. Interview data will be analysed qualitatively to identify themes specifically related to the practical feasibility of the intervention.

Trial sites (2)

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