Chronic Kidney Disease (Stages 4 and 5)COMFORTNCT07815639
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
A study testing COMFORT Intervention in people with Chronic Kidney Disease (Stages 4 and 5), run by University of Aarhus at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (Stages 4 and 5)
- What is being tested?
- COMFORT Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 Sep 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Informal caregivers:
- Age 18 years or older
- Identified by a participating patient as an informal caregiver or close relative
- Able to provide informed consent
Who cannot join
- Patients:
- Unable to speak or read Danish
- Unable to provide informed consent
- Unable to complete study questionnaires
- Severe psychiatric disorder
- Informal caregivers:
Show all 9Show fewer
- Unable to speak Danish
- Unable to complete study questionnaires
- Unable to provide informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites
Aarhus University Hospital
Aarhus, Central Jutland, 8200
Jeanette Finderup, 004578452525, jeajee@rm.dk
Signe Damsgaard
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Capital Region, 2100
Anne Sophie Mathiesen, 004527908669, Anne.Sophie.Mathiesen@regionh.dk
Nina Schjerning
About this study
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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease (Stages 4 and 5)
- Being tested
- COMFORT Intervention, Usual Care
- Keywords
- Advanced Kidney Disease, Chronic Kidney Disease Stage 5, Chronic Kidney Disease Stage 4, Kidney Failure, Symptom Management, Nurse-Led Intervention, Self-Management, Shared Decision-Making, Informal Caregivers, Supportive CAre, COMFORT intervention, Feasibility Study
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMFORT InterventionBehavioural
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 CareOther
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 group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | 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. Receives: Other: Usual Care |
| COMFORT Intervention | Experimental | 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. Receives: Behavioral: COMFORT Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months
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.
Measured: 3 months after enrolment
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.
Measured: Baseline and 3 months
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.
Measured: Baseline and 3 months
Completeness of Questionnaire Data
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.
Measured: Baseline and 3 months
Acceptability of the COMFORT Intervention Assessed by Qualitative Interviews
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.
Measured: At 3 months
Perceived Relevance of the COMFORT Intervention Assessed by Qualitative Interviews
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.
Measured: At 3 months
Perceived Feasibility of the COMFORT Intervention Assessed by Qualitative Interviews
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.
Measured: At 3 months
Secondary outcomes (7)
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.
Measured: Baseline and 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.
Measured: Baseline and 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.
Measured: Baseline and 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.
Measured: Baseline and 3 months.
Change From Baseline in Shared Decision-Making Assessed With the Patient Experience of Shared Decision Making Questionnaire at 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.
Measured: Baseline and 3 months
Change From Baseline in Self-Management Assessed With the Chronic Kidney Disease Self-Management Questionnaire at 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.
Measured: Baseline and 3 months
Change From Baseline in Caregiver Burden Assessed With the 12-Item Zarit Burden Interview at 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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease (Stages 4 and 5)Studies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815639
- Sponsor's protocol ID
- COMFORT-FS-2026
- Other IDs
- 0082713
- Acronym
- COMFORT
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared with other researchers. Study data will be handled in accordance with applicable data protection regulations and institutional requirements.
Publications
Finderup J, Agerskov H, Deele M, Frandsen CE, Kristensen IV, Bonner A, Konradsen H. Tailored Complex Symptom Management Intervention for Adults with Advanced Kidney Disease and Their Informal Caregivers: Protocol for the COMFORT Research Program. Nephron. 2026;150(2):65-75. doi: 10.1159/000548903. Epub 2025 Oct 13.
PubMed 41078064
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07815639
- Acronym / sponsor ID
- COMFORT / COMFORT-FS-2026
- Conditions
- Chronic Kidney Disease (Stages 4 and 5)
- Keywords
- Advanced Kidney Disease, Chronic Kidney Disease Stage 5, Chronic Kidney Disease Stage 4, Kidney Failure, Symptom Management, Nurse-Led Intervention, Self-Management, Shared Decision-Making
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareParticipants 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. |
| COMFORT Intervention | Experimental | Behavioral: COMFORT InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- Unable to speak or read Danish
- Unable to provide informed consent
- Unable to complete study questionnaires
- Severe psychiatric disorder
- Unable to speak Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COMFORT InterventionThe 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. | Behavioural | COMFORT Intervention |
| Usual CareParticipants 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. | Other | Usual Care |
Primary outcome
Recruitment Rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Change From Baseline in Symptom Burden Assessed With the Integrated Palliative care Outcome Scale-Renal at 3 Months
Time frame: Baseline and 3 months
Change From Baseline in EuroQol 5-Dimension 3-Level Index Score at 3 Months
Time frame: Baseline and 3 months.
Change From Baseline in Fatigue Severity Scale Score at 3 Months
Time frame: Baseline and 3 months.
Change From Baseline in Life Participation Assessed With Standardised Outcomes in Nephrology-Life Participation at 3 Months
Time frame: Baseline and 3 months.
Change From Baseline in Shared Decision-Making Assessed With the Patient Experience of Shared Decision Making Questionnaire at 3 Months
Time frame: Baseline and 3 months
Change From Baseline in Self-Management Assessed With the Chronic Kidney Disease Self-Management Questionnaire at 3 Months
Time frame: Baseline and 3 months
Change From Baseline in Caregiver Burden Assessed With the 12-Item Zarit Burden Interview at 3 Months
Time frame: Baseline to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 41078064Finderup J, Agerskov H, Deele M, Frandsen CE, Kristensen IV, Bonner A, Konradsen H. Tailored Complex Symptom Management Intervention for Adults with Advanced Kidney Disease and Their Informal Caregivers: Protocol for the COMFORT Research Program. Nephron. 2026;150(2):65-75. doi: 10.1159/000548903. Epub 2025 Oct 13.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared with other researchers. Study data will be handled in accordance with applicable data protection regulations and institutional requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMFORT Intervention in people with Chronic Kidney Disease (Stages 4 and 5), run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeanette Finderup (004578452525, jeajee@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Baseline and 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07815639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.