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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
详细描述
Adults with advanced kidney disease may experience a substantial burden of physical and psychosocial symptoms, including fatigue, drowsiness, pruritus, pain, and restless legs. Multiple symptoms frequently occur at the same time and can negatively affect daily functioning, quality of life, and participation in everyday activities. Informal caregivers may also experience considerable burden, emotional strain, and uncertainty about how best to support the person with advanced kidney disease.
Despite the high symptom burden, systematic symptom assessment and management are not consistently integrated into routine kidney care. Symptom management strategies may focus on individual symptoms rather than addressing multiple co-occurring symptoms and the broader needs and preferences of patients and their informal caregivers. Patients and caregivers may therefore benefit from a more structured approach that supports symptom recognition and management, shared decision-making, self-management, and caregiver involvement.
The COMFORT Nursing Programme was established in 2023 to address these challenges. The programme has developed a structured, theory-informed, nurse-led intervention for symptom management in adults with advanced kidney disease. The COMFORT intervention comprises four core components: symptom management, shared decision-making, self-management support, and caregiver support.
The intervention combines systematic symptom assessment using the Integrated Palliative care Outcome Scale-Renal (IPOS-Renal) with an evidence-based symptom management decision-support tool. Based on the symptoms, needs, and preferences identified by the participant, trained nephrology nurses support participants in prioritising symptoms, considering relevant symptom management strategies, participating in shared decisions, and strengthening their ability to manage symptoms in everyday life. Informal caregivers are involved and supported as part of the intervention.
In this randomized feasibility study, adults with advanced kidney disease are allocated in a 1:1 ratio to usual care or usual care supplemented with the COMFORT intervention. The intervention is delivered over approximately 3 months and comprises two structured nurse-led consultations and one follow-up telephone consultation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors are blinded to treatment allocation. Due to the nature of the intervention, participants, care providers, and investigators delivering the intervention cannot be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Unable to speak or read Danish
- •Unable to provide informed consent
- •Unable to complete study questionnaires
- •Severe psychiatric disorder
- •Informal caregivers:
- •Unable to speak Danish
- •Unable to complete study questionnaires
- •Unable to provide informed consent
研究组 & 干预措施
Usual Care
Participants allocated to the control group receive usual kidney care according to standard clinical practice at the participating nephrology departments during the 3 months study period.
干预措施: Usual Care (Other)
COMFORT Intervention
Participants allocated to the intervention group receive usual kidney care supplemented with the COMFORT intervention during the 3 months study period. The COMFORT intervention is a tailored, nurse-led symptom management intervention that includes systematic symptom assessment, a symptom management decision-support tool, shared decision-making, self-management support, and involvement and support of informal caregivers. The intervention is delivered by trained nephrology nurses through two structured consultations and one follow-up telephone consultation.
干预措施: COMFORT Intervention (Behavioral)
结局指标
主要结局
Recruitment Rate
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Change From Baseline in Symptom Burden Assessed With the Integrated Palliative care Outcome Scale-Renal at 3 Months(Baseline and 3 months)
- Change From Baseline in EuroQol 5-Dimension 3-Level Index Score at 3 Months(Baseline and 3 months.)
- Change From Baseline in Fatigue Severity Scale Score at 3 Months(Baseline and 3 months.)
- Change From Baseline in Life Participation Assessed With Standardised Outcomes in Nephrology-Life Participation at 3 Months(Baseline and 3 months.)
- Change From Baseline in Shared Decision-Making Assessed With the Patient Experience of Shared Decision Making Questionnaire at 3 Months(Baseline and 3 months)
- Change From Baseline in Self-Management Assessed With the Chronic Kidney Disease Self-Management Questionnaire at 3 Months(Baseline and 3 months)
- Change From Baseline in Caregiver Burden Assessed With the 12-Item Zarit Burden Interview at 3 Months(Baseline to 3 months)