Family TIME: A Family-focused Nursing Intervention for Adults Receiving Haemodialysis and Their Families
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Jeannett A Klitgaard, Master of Science in Nursing
- 电话号码:+4540478192
- 邮箱:jekl@ucl.dk
学习地点
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Odense、丹麦
- Odense University Hospital
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接触:
- Hanne Agerskov, Professor
- 电话号码:+45 2942 7086
- 邮箱:Hanne.Agerskov@rsyd.dk
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预:Usual care
Participants allocated to the control group will receive usual care provided by the participating haemodialysis units throughout the study period.
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实验性的:Family Time + Usual Care
Participants allocated to the intervention group will receive the Family Time intervention in addition to usual care.
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Recruitment rate
大体时间:From the first family conversation to completion of the intervention, up to 8 weeks.
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Number and proportion of eligible family units recruited into the study.
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From the first family conversation to completion of the intervention, up to 8 weeks.
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Retention rate
大体时间:8 weeks after baseline
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Number and proportion of participants completing follow-up.
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8 weeks after baseline
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Intervention delivery
大体时间:From the first family conversation through completion of the intervention, up to 8 weeks.
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Number and proportion of planned structured facilitated family conversations completed according to protocol.
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From the first family conversation through completion of the intervention, up to 8 weeks.
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Intervention acceptability
大体时间:8 weeks after baseline
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Acceptability assessed using the Danish version of the Acceptability of Intervention Measure (AIM).
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8 weeks after baseline
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Study procedures
大体时间:Baseline and Week 9
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Questionnaire completion rate, follow-up completion and completeness of data collection procedures.
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Baseline and Week 9
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Implementation considerations
大体时间:Throughout the 8-week intervention period and at post-intervention interview in Week 9
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Barriers and facilitators identified through intervention logs, facilitator field notes and qualitative interviews.
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Throughout the 8-week intervention period and at post-intervention interview in Week 9
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Family functioning
大体时间:Baseline and 8 weeks after baseline.
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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.
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Baseline and 8 weeks after baseline.
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Individual well-being
大体时间:Baseline and 8 weeks after baseline.
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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.
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Baseline and 8 weeks after baseline.
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合作者和调查者
调查人员
- 研究主任:Hanne Agerskov, Professor、Odense University Hospital
出版物和有用的链接
一般刊物
- Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
- Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
- Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016.
- Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. Int J Nurs Stud. 2024 Jun;154:104705. doi: 10.1016/j.ijnurstu.2024.104705. Epub 2024 Feb 24.
- Sveinbjarnardottir EK, Svavarsdottir EK, Hrafnkelsson B. Psychometric development of the Iceland-Expressive Family Functioning Questionnaire (ICE-EFFQ). J Fam Nurs. 2012 Aug;18(3):353-77. doi: 10.1177/1074840712449204. Epub 2012 Jun 29.
- Gillespie KM, Purtell L, Finderup J, Schjerning N, Bonner A. Interventions to Reduce Burden Among Informal Caregivers of People With Chronic Kidney Disease: Systematic Review and Meta-Analysis. J Ren Care. 2026 Jun;52(2):e70063. doi: 10.1111/jorc.70063.
- Azcarate-Cenoz N, Canga-Armayor A, Alfaro-Diaz C, Canga-Armayor N, Pueyo-Garrigues M, Esandi N. Family-Oriented Therapeutic Conversations: A Systematic Scoping Review. J Fam Nurs. 2024 May;30(2):145-173. doi: 10.1177/10748407241235141. Epub 2024 Mar 26.
- Araujo H, Marques E, Lourenco I, Bonifacio C, Gomes F. Nursing Interventions to Support Family Caregivers of Patients on Haemodialysis: A Mixed-Methods Systematic Review. J Adv Nurs. 2026 Jun;82(6):5813-5834. doi: 10.1111/jan.70297. Epub 2025 Oct 29.
- Sousa H, Ribeiro O, Figueiredo D. Purpose in life among haemodialysis caregivers: Links with adaptive coping, caregiver burden, and psychological distress. Stress Health. 2024 Oct;40(5):e3460. doi: 10.1002/smi.3460. Epub 2024 Aug 12.
- Yapa HE, Purtell L, Chambers S, Bonner A. The Relationship Between Chronic Kidney Disease, Symptoms and Health-Related Quality of Life: A Systematic Review. J Ren Care. 2020 Jun;46(2):74-84. doi: 10.1111/jorc.12303. Epub 2019 Nov 3.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Family TIME
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
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