Family TIME: A Family-focused Nursing Intervention for Adults Receiving Haemodialysis and Their Families

Sponsor
University of Southern Denmark
Study ID
NCT07801937
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Family TIME — OTHER
    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.

Study Details

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.

Key Dates

First listed
Sep 3, 2026
Start date
Aug 10, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: Usual care
    Participants allocated to the control group will receive usual care provided by the participating haemodialysis units throughout the study period.
  • Experimental: Family Time + Usual Care
    Participants allocated to the intervention group will receive the Family Time intervention in addition to usual care.

Primary Outcome Measure

Recruitment rate [ Time Frame: From the first family conversation to completion of the intervention, up to 8 weeks. ]

Central Contacts

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