An interventional study of COMFORT Intervention and Usual Care in Chronic Kidney Disease (Stages 4 and 5), sponsored by University of Aarhus. Not yet recruiting at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by University of Aarhus · Not applicable, Interventional, and Supportive care
Among 116 studies in Renal Insufficiency, Chronic with a site in Denmark — 27 open to participants now, 35 under way, 9 of them phase 3. Renal Insufficiency, Chronic · Denmark.
Among the 116 studies in Renal Insufficiency, Chronic with a site in Denmark, this one is the 49th largest by planned enrollment of the 90 interventional ones, is one of 8 that started in 2026, is one of 27 with no phase, reaches primary completion later than 16 of the 34 other live ones, and was the 114th registered.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's planned enrollment of 112 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →27 of the 116 studies in Renal Insufficiency, Chronic with a site in Denmark are open now, in 12 countries. Each count lists the studies.
Of the 435 Renal Insufficiency, Chronic studies recruiting now, 245 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →116 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 8 started in 2026.
Median enrollment 136 across the 90 interventional studies, 321 across the 26 observational. Of the 73 that completed or were terminated, 28 (38%) have results posted.
52 of 116 have an industry lead sponsor. The 10 most frequent:
University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
University of Aarhus has 8 studies filed under Renal Insufficiency, Chronic — fewer than ten, so there is no comparison to draw.
9 of the studies in Renal Insufficiency, Chronic with a site in Denmark that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06531824Phase 3Boehringer IngelheimEASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin) | 2026-12-31 |
| NCT05196035Phase 3BayerA Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria | 2027-04-10 |
| NCT05970172Phase 3Astellas Pharma Global Development, Inc.A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease | 2027-10-30 |
| NCT07781371Novo Nordisk A/SA Retrospective Real-World Cohort Study | 2026-11-02 |
| NCT07026539University of AarhusEffect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes. | 2026-12-31 |
Among the 116 studies in Renal Insufficiency, Chronic with a site in Denmark, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients:
Informal caregivers:
Exclusion Criteria:
Patients:
Informal caregivers:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Usual Care
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.
Behavioral: 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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 3 months
Plan to share: 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.
Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.
Of 576 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 5 months is below that.
Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →