Family TIME: A Family-focused Nursing Intervention for Adults Receiving Haemodialysis and Their Families
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern Denmark
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Family TIME
Other interventionParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Usual careNo intervention 0 interventions
Group B: Family Time + Usual CareExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
Number and proportion of eligible family units recruited into the study.
Time frame
From the first family conversation to completion of the intervention, up to 8 weeks.2
Retention rate
Number and proportion of participants completing follow-up.
Time frame
8 weeks after baseline3
Intervention delivery
Number and proportion of planned structured facilitated family conversations completed according to protocol.
Time frame
From the first family conversation through completion of the intervention, up to 8 weeks.4
Intervention acceptability
Acceptability assessed using the Danish version of the Acceptability of Intervention Measure (AIM).
Time frame
8 weeks after baselineSecondary outcomes
1
Family functioning
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.
Time frame
Baseline and 8 weeks after baseline.2
Individual well-being
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.
Time frame
Baseline and 8 weeks after baseline.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Southern Denmark
Lead sponsor
Odense University Hospital
Collaborator
Griffith University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: