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 (COMFORT)
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
The primary purpose of the study is to evaluate the feasibility and acceptability of the COMFORT intervention and the procedures required for a future definitive randomised controlled trial. The study will therefore evaluate recruitment and retention, intervention fidelity, acceptability among participants and nephrology nurses, completion and suitability of proposed outcome measures, and the feasibility of study procedures. Patient-reported and caregiver-reported measures will also be collected to evaluate their suitability for a future trial.
The feasibility findings will be used to refine the COMFORT intervention and study procedures and to inform the design and conduct of a future multicentre randomised controlled trial evaluating the effectiveness of the COMFORT intervention.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Jeanette Finderup
- Telefonní číslo: 004578452525
- E-mail: jeajee@rm.dk
Studijní místa
-
-
Capital Region
-
Copenhagen, Capital Region, Dánsko, 2100
- Rigshospitalet, Copenhagen University Hospital
-
Kontakt:
- Anne Sophie Mathiesen
- Telefonní číslo: 004527908669
- E-mail: Anne.Sophie.Mathiesen@regionh.dk
-
Kontakt:
- Nina Schjerning
-
-
Central Jutland
-
Aarhus, Central Jutland, Dánsko, 8200
- Aarhus University Hospital
-
Kontakt:
- Jeanette Finderup
- Telefonní číslo: 004578452525
- E-mail: jeajee@rm.dk
-
Dílčí vyšetřovatel:
- Signe Damsgaard
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
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 Criteria:
Patients:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
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.
|
|
Experimentální: 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.
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Recruitment Rate
Časové okno: 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.
|
Baseline and 3 months
|
|
Participant Retention Rate at 3 Months
Časové okno: 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.
|
3 months after enrolment
|
|
Adherence to the COMFORT Intervention
Časové okno: 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.
|
Baseline and 3 months
|
|
Fidelity to the COMFORT Intervention
Časové okno: 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.
|
Baseline and 3 months
|
|
Completeness of Questionnaire Data
Časové okno: 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.
|
Baseline and 3 months
|
|
Acceptability of the COMFORT Intervention Assessed by Qualitative Interviews
Časové okno: 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.
|
At 3 months
|
|
Perceived Relevance of the COMFORT Intervention Assessed by Qualitative Interviews
Časové okno: 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.
|
At 3 months
|
|
Perceived Feasibility of the COMFORT Intervention Assessed by Qualitative Interviews
Časové okno: 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.
|
At 3 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change From Baseline in Symptom Burden Assessed With the Integrated Palliative care Outcome Scale-Renal at 3 Months
Časové okno: Baseline and 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.
|
Baseline and 3 months
|
|
Change From Baseline in EuroQol 5-Dimension 3-Level Index Score at 3 Months
Časové okno: Baseline and 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.
|
Baseline and 3 months.
|
|
Change From Baseline in Fatigue Severity Scale Score at 3 Months
Časové okno: Baseline and 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.
|
Baseline and 3 months.
|
|
Change From Baseline in Life Participation Assessed With Standardised Outcomes in Nephrology-Life Participation at 3 Months
Časové okno: Baseline and 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.
|
Baseline and 3 months.
|
|
Change From Baseline in Shared Decision-Making Assessed With the Patient Experience of Shared Decision Making Questionnaire at 3 Months
Časové okno: Baseline and 3 months
|
Shared decision-making will be assessed using the Danish version of the 10-item Patient Experience of Shared Decision Making Questionnaire (SHARED-10).
Each item is rated on a 5-point Likert scale from strongly disagree to strongly agree, with higher item scores indicating greater perceived shared decision-making.
The instrument assesses three domains: healthcare professional contribution (items 1-4), patient contribution (items 5-7), and shared agreement in the decision (items 8-10).
Change from baseline to 3 months will be assessed.
|
Baseline and 3 months
|
|
Change From Baseline in Self-Management Assessed With the Chronic Kidney Disease Self-Management Questionnaire at 3 Months
Časové okno: Baseline and 3 months
|
Self-management will be assessed using the 17-item short version of the Chronic Kidney Disease Self-Management questionnaire (CKD-SM-17).
Each item is rated on a 4-point response scale from never to always.
Item scores range from 1 to 4, giving a total score ranging from 17 to 68, with higher scores indicating greater engagement in self-management behaviours.
The outcome will be the change in total score from baseline to 3 months.
|
Baseline and 3 months
|
|
Change From Baseline in Caregiver Burden Assessed With the 12-Item Zarit Burden Interview at 3 Months
Časové okno: Baseline to 3 months
|
Caregiver burden will be assessed among participating informal caregivers using the 12-item Zarit Burden Interview (ZBI-12).
The total score ranges from 0 to 48, with higher scores indicating greater caregiver burden.
The outcome will be the change in total score from baseline to 3 months.
|
Baseline to 3 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Patologické procesy
- Mužská urogenitální onemocnění
- Onemocnění ledvin
- Urologická onemocnění
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Chronické onemocnění
- Atributy nemoci
- Patologické stavy, příznaky a symptomy
- Renální insuficience
- Renální insuficience, chronická
Další identifikační čísla studie
- COMFORT-FS-2026
- 0082713 (Jiné číslo grantu/financování: Novo Nordic Foundation)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .