Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07801937

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

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 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.

  2. Retention rate

    Time frame: 8 weeks after baseline

    Number and proportion of participants completing follow-up.

  3. Intervention delivery

    Time frame: 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.

  4. Intervention acceptability

    Time frame: 8 weeks after baseline

    Acceptability assessed using the Danish version of the Acceptability of Intervention Measure (AIM).

  5. Study procedures

    Time frame: Baseline and Week 9

    Questionnaire completion rate, follow-up completion and completeness of data collection procedures.

  6. Implementation considerations

    Time frame: 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 outcomes

  1. Family functioning

    Time frame: 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.

  2. Individual well-being

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeannett A Klitgaard, Master of Science in Nursing

CONTACT

[email protected]

+4540478192

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Griffith University
  • Odense University Hospital

Registry information

Official study title

Family TIME: Protocol for a Randomised Mixed-methods Feasibility Study of a Family-focused Nursing Intervention for Adults Receiving Haemodialysis and Their Families

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.