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

NCT07801937 | Not Yet Recruiting

• 1 other identifier: Family TIME
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease; Hemodialysis

Keywords

Chronic Kidney Disease; Hemodialysis; Family; Family conversations; Family intervention; Family functioning

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

  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

  Number and proportion of participants completing follow-up.

  8 weeks after baseline

• Intervention delivery

  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

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

  8 weeks after baseline

• Study procedures

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

  Baseline and Week 9

• Implementation considerations

  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

Secondary Outcomes (2)

• Family functioning

  Baseline and 8 weeks after baseline.

• Individual well-being

  Baseline and 8 weeks after baseline.

Study Arms (2)

Usual care

NO INTERVENTION

Participants allocated to the control group will receive usual care provided by the participating haemodialysis units throughout the study period.

Family Time + Usual Care

EXPERIMENTAL

Participants allocated to the intervention group will receive the Family Time intervention in addition to usual care.

Other: Family TIME

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.

Family Time + Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• Odense University Hospital: collaborator
• Griffith University: collaborator

Study Sites (1)

Odense University Hospital

Odense, Denmark

Location

Related Publications (10)

• 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.

  PMID: 25831962 BACKGROUND

• 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.

  PMID: 22752795 BACKGROUND

• 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.

  PMID: 27777223 BACKGROUND

• 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.

  PMID: 26978655 BACKGROUND

• 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.

  PMID: 38564982 BACKGROUND

• 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.

  PMID: 42159051 BACKGROUND

• 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.

  PMID: 38529615 BACKGROUND

• 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.

  PMID: 41159560 BACKGROUND

• 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.

  PMID: 39134404 BACKGROUND

• 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.

  PMID: 31680483 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hanne Agerskov, Professor

  Odense University Hospital

  STUDY DIRECTOR

Central Study Contacts

Jeannett A Klitgaard, Master of Science in Nursing

CONTACT

+4540478192; jekl@ucl.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding is not feasible because participants, family members, and the intervention facilitator are aware of participation in the family conversation intervention. The study is therefore conducted as an open-label feasibility trial.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: September 3, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: September 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months after publication of the primary results and continuing for 5 years.
• Access Criteria: 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.

Locations

DK (1)