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

31 de agosto de 2026 atualizado por: University of Southern Denmark

Family TIME: Protocol for a Randomised Mixed-methods Feasibility Study of 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Jeannett A Klitgaard, Master of Science in Nursing
  • Número de telefone: +4540478192
  • E-mail: jekl@ucl.dk

Locais de estudo

  • Dinamarca
      • Odense, Dinamarca
        • Odense University Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: 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.
Outro: Family 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Recruitment rate
Prazo: 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.
From the first family conversation to completion of the intervention, up to 8 weeks.
Retention rate
Prazo: 8 weeks after baseline
Number and proportion of participants completing follow-up.
8 weeks after baseline
Intervention delivery
Prazo: 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.
From the first family conversation through completion of the intervention, up to 8 weeks.
Intervention acceptability
Prazo: 8 weeks after baseline
Acceptability assessed using the Danish version of the Acceptability of Intervention Measure (AIM).
8 weeks after baseline
Study procedures
Prazo: Baseline and Week 9
Questionnaire completion rate, follow-up completion and completeness of data collection procedures.
Baseline and Week 9
Implementation considerations
Prazo: 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.
Throughout the 8-week intervention period and at post-intervention interview in Week 9

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Family functioning
Prazo: 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.
Baseline and 8 weeks after baseline.
Individual well-being
Prazo: 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.
Baseline and 8 weeks after baseline.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Southern Denmark

Colaboradores

Odense University Hospital
Griffith University

Investigadores

  • Diretor de estudo: Hanne Agerskov, Professor, Odense University Hospital

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

10 de agosto de 2026

Conclusão Primária (Estimado)

31 de março de 2027

Conclusão do estudo (Estimado)

31 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

6 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

31 de agosto de 2026

Primeira postagem (Real)

3 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de agosto de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • Family TIME

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

De-identified individual participant data underlying the results reported in publications will be made available upon reasonable request, subject to approval by the study investigators, applicable ethical approvals, institutional policies, and Danish data protection regulations.

Prazo de Compartilhamento de IPD

Beginning 3 months after publication of the primary results and continuing for 5 years.

Critérios de acesso de compartilhamento IPD

Data will be available to qualified researchers for scientifically sound research purposes following publication of the primary study results. Requests will be reviewed by the study investigators and the data controller.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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