Chronic Kidney Disease, Hemodialysis
Conditions
Keywords
Chronic Kidney Disease, Hemodialysis, Family, Family conversations, Family intervention, Family functioning
Brief summary
The goal of this clinical trial is to evaluate whether a structured family conversation intervention can be delivered in a feasible and acceptable way to adults living with chronic kidney disease (CKD) and their family members. The study will also explore whether the intervention and study procedures are suitable for a future larger clinical trial. The main questions it aims to answer are: Can adults with CKD and their family members be successfully recruited, enrolled, and retained throughout the study? Is the Family Time intervention acceptable and practical for patients, family members, and healthcare professionals? Are the study procedures and selected questionnaires appropriate for evaluating a future larger trial? Does the intervention show potential to support family functioning and well-being? Researchers will compare the Family Time intervention plus usual care with usual care alone. Participants will: Complete questionnaires before and after the study period. Be allocated to either the Family Time intervention or usual care. If allocated to the intervention group, participate in three structured family conversations over approximately 8 weeks, with the option of one additional follow-up conversation. If allocated to the intervention group, be invited to take part in an interview about their experiences after completing the intervention.
Detailed description
Adults living with chronic kidney disease (CKD) experience substantial physical, emotional, and social challenges that extend beyond the individual and influence everyday family life. Family members frequently take on important supportive roles while simultaneously experiencing changes in family routines, responsibilities, communication, and well-being. Although family involvement is recognised as an important component of person-centred CKD care, structured family-focused interventions remain limited, and evidence supporting their implementation in routine nephrology practice is scarce. This study aims to evaluate the feasibility and acceptability of Family Time, a nurse-led family-focused intervention developed to support communication, shared understanding, and relational well-being among adults living with CKD and their families. The intervention has been developed following the Medical Research Council (MRC) framework for developing and evaluating complex interventions and informed by evidence synthesis, qualitative research, stakeholder workshops, and patient and family involvement. A mixed-methods randomised feasibility trial will be conducted at two in-centre haemodialysis units in Denmark. Adults receiving in-centre haemodialysis and at least one participating family member will be allocated to either the Family Time intervention plus usual care or usual care alone. The intervention consists of three structured family conversations delivered over approximately 8 weeks, with the option of one additional follow-up conversation. Sessions are facilitated by the principal investigator and may be delivered face-to-face, online, or by telephone according to family preferences and practical circumstances. The primary outcomes are feasibility and acceptability of the intervention and study procedures, including recruitment, retention, intervention delivery, questionnaire completion, and participant experiences. Secondary exploratory outcomes include family functioning, individual well-being, and family communication, assessed using the Iceland Expressive Family Functioning Questionnaire (ICE-EFFQ), the WHO-5 Well-Being Index, and post-intervention qualitative interviews. The findings will inform refinement of both the intervention and study procedures and determine whether progression to a future definitive randomised controlled trial is warranted.
Interventions
OTHERFamily TIME
Participants allocated to the intervention group will receive the Family Time intervention in addition to usual care. The intervention consists of three structured family conversations delivered over approximately 8 weeks, with the option of one additional follow-up session. Conversations are facilitated by the principal investigator and may be delivered face-to-face, online, or by telephone according to family preferences and practical circumstances.
Sponsors
University of Southern Denmark
Odense University Hospital
Griffith University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Blinding is not feasible because participants, family members, and the intervention facilitator are aware of participation in the family conversation intervention. The study is therefore conducted as an open-label feasibility trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient aged 18 years or older * Currently receiving in-centre haemodialysis for CKD * Has received in-centre haemodialysis for at least 3 months * Able to read, speak, and understand Danish * Able to provide written informed consent * Able to identify at least one family member willing to participate * Participating family member aged 18 years or older * Participating family member able to speak and understand Danish * Participating family member able to provide written informed consent
Exclusion criteria
* Documented cognitive impairment preventing informed consent or participation * Clinically assessed as too physically or psychologically unwell to participate * Unable to participate in Danish * Currently receiving structured family therapy or another family-focused psychosocial intervention
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | From the first family conversation to completion of the intervention, up to 8 weeks. | Number and proportion of eligible family units recruited into the study. |
| Retention rate | 8 weeks after baseline | Number and proportion of participants completing follow-up. |
| Intervention delivery | From the first family conversation through completion of the intervention, up to 8 weeks. | Number and proportion of planned structured facilitated family conversations completed according to protocol. |
| Intervention acceptability | 8 weeks after baseline | Acceptability assessed using the Danish version of the Acceptability of Intervention Measure (AIM). |
| Study procedures | Baseline and Week 9 | Questionnaire completion rate, follow-up completion and completeness of data collection procedures. |
| Implementation considerations | Throughout the 8-week intervention period and at post-intervention interview in Week 9 | Barriers and facilitators identified through intervention logs, facilitator field notes and qualitative interviews. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Family functioning | Baseline and 8 weeks after baseline. | Family functioning will be assessed using the Iceland Expressive Family Functioning Questionnaire (ICE-EFFQ), a 17-item questionnaire assessing expressive family functioning, including communication, emotional expression, collaboration and family relationships. Total scores range from 17 to 85, with higher scores indicating more positive expressive family functioning. |
| Individual well-being | Baseline and 8 weeks after baseline. | Subjective well-being will be assessed using the World Health Organization Five Well-Being Index (WHO-5). Raw scores range from 0 to 25 and are transformed to a scale from 0 to 100, with higher scores indicating greater subjective well-being. |
Countries
Denmark
Contacts
CONTACTJeannett A Klitgaard, Master of Science in Nursing
STUDY_DIRECTORHanne Agerskov, Professor
Odense University Hospital
Outcome results
None listed