Developing an Arts-based Intervention for Patients With End-stage Kidney Disease Whilst Receiving Haemodialysis

NCT ID: NCT03629496

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-03
• Study Completion Date: 2019-01-21

Brief Summary

This research study aims to develop an arts-based intervention for patients with end-stage kidney disease (ESKD) that can be implemented during haemodialysis sessions, and to assess the feasibility of a randomised controlled trial (RCT). Haemodialysis is the most common treatment for patients with ESKD; it involves attending hospital three times a week for a period of four hours each time, during that time the patient is connected to a dialysing unit that drains and filters their blood, performing the role of the damaged kidneys. Patients with ESKD receiving haemodialysis report low quality of life (QoL) and poor mental health. Arts-based interventions have been used in a variety of different settings to improve both QoL and mental health, but there's a lack of research assessing their effectiveness in patients with ESKD receiving haemodialysis.

This study will develop an arts-based intervention by reviewing the existing literature and forming an advisory group consisting of patients, healthcare staff, artists and academics. Once developed a feasibility RCT will be conducted on a haemodialysis unit. The feasibility RCT will involve establishing the recruitment, participation and retention rates of patients who are eligible for inclusion. A process evaluation will be conducted alongside the feasibility trial; this will involve interviews with patients and focus groups with staff to explore experiences of the intervention. Finally a feasibility economic evaluation will be conducted to explore methods for a cost-effectiveness analysis within an RCT. The hope is this study will contribute to a future RCT that will evaluate the impact of arts-based interventions on the QoL and mental health of patients receiving haemodialysis.

Detailed Description

This study consists of four phases and will utilise a mixed methods design. The first phase is the development of the intervention, the second phase is a feasibility randomised controlled trial (RCT), the third phase is a qualitative process evaluation and the fourth phase is a feasibility economic evaluation.

The first phase will involve the development of the intervention and will follow the development framework published by Fancourt in 'Arts in Health' (2017). This framework was developed specifically to inform arts-based interventions for healthcare contexts, and focuses primarily on identifying the needs of patients and staff within the clinical setting. The development will be informed by a systematic literature review and an interdisciplinary advisory group. The advisory group will consist of three patient representatives, two staff representatives from the haemodialysis unit, a renal counsellor from the Northern Health and Social Care Trust, two artist representatives from Arts Care Northern Ireland, the Chief Executive Officer from Arts Care Northern Ireland, the Community Wellbeing Manager in the Northern Health and Social Care Trust, a representative from the Renal Arts Group at Queen's, a representative from the University of Florida Arts in Medicine faculty, and a statistician. They will meet approximately every three months to inform the intervention and the research process.

The second phase will be a feasibility RCT that will involve recruiting 30 participants from Antrim Area Hospital's haemodialysis unit. Feasibility RCT's are necessary to determine whether a definitive randomised controlled trial can and should be conducted, and to identify the key areas within the methodology that work well or need to be adapted.

Recruitment will take place over seven months.Half the participants will be randomly allocated to the experimental group who will receive the intervention and half will be randomly allocated to the control group who will receive usual care.Participants will not be randomly allocated on an individual level, but instead will be randomly allocated according to the days of the week that they attend for haemodialysis. Patients receiving haemodialysis attend hospital on a set shift pattern, either Monday, Wednesday and Friday, or Tuesday, Thursday and Saturday. As the unit is open planned there is a risk that participants allocated to the control group will observe the intervention taking place if random allocation is done on an individual basis and this may influence the outcome; therefore randomisation will occur according to shift pattern to reduce the risk of contamination. The intervention will consist of an artistic activity that is minimally disruptive to the clinical setting, such as painting, sketching, pen and ink or creative writing. The intervention will be done at the bedside and will be adapted to ensure that vascular access is maintained. In order to ensure infection control protocols are followed each participant will receive their own set of art supplies to prevent the potential spread of infection through contaminated shared materials. The intervention will involve 6 sessions that will be administered over the course of 3 weeks for approximately an hour during dialysis sessions.

The third phase is the qualitative process evaluation. Participants will consist of both patients on the unit and staff who are working within the unit. Patients recruited will include those who have participated in phase two of the study, both in the intervention and control group. Semi-structured interviews will be conducted with 13 patients in order to capture a broad range of experiences with the intervention and the research process, including potential methods to make the intervention more accessible or engaging, experiences of being randomisation and participating in a control group, and reasons for retention of participants. 3 focus groups will be conducted with healthcare staff who have experienced the intervention on the unit. Due to the potential impact that arts-based interventions could have on the responsibilities of staff and the environment that they work in it is important to consider their experiences within the process evaluation as well, including identifying any barriers or facilitators to implementing the intervention in the dialysis setting.

Phase four is the feasibility economic evaluation. Participants who have been recruited into phase two of the study will be asked to complete a Patient Service Use Log throughout the study, this will be completed with the PhD student during the haemodialysis session, and the approximate cost of the intervention will be also be calculated.

Conditions

Feasibility Study; End Stage Renal Disease on Dialysis (Diagnosis)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arts-based intervention

Participants will participate in 6x1 hourly art sessions over a period of 3 weeks while they receive their haemodialysis treatment. This will involve 1:1 facilitation with a student and will involve visual arts including sketching, water colour painting and pen and ink, and creative writing activities. Participants will be provided with their own art supplies for infection control purposes and these will be kept on the unit in between sessions. Participants will have an option of displaying completed work in the reception area of the unit during their sessions.

Group Type: EXPERIMENTAL

Arts-based intervention

Intervention Type: OTHER

6x1 hourly facilitated art sessions during haemodialysis. Participants will be provided with an option of visual art or creative writing, the artistic materials used will include graphite pencils, colouring pencils, water colour paints and graphic pens. Participants will be provided with their own art supplies for infection control purposes. During each session participants will be allowed to self-select a subject matter or be provided with binary prompts to facilitate decision making. Participants will also have an option of displaying completed work in the reception area of the unit during their haemodialysis sessions.

Control

Participants will receive usual care during their haemodialysis sessions and will be asked not to engage in any creative writing or visual arts during their haemodialysis sessions for the duration of the study. Once data collection has been completed the participants in the control group will receive art supplies and a single facilitated session on haemodialysis for the purpose of equity.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Arts-based intervention

6x1 hourly facilitated art sessions during haemodialysis. Participants will be provided with an option of visual art or creative writing, the artistic materials used will include graphite pencils, colouring pencils, water colour paints and graphic pens. Participants will be provided with their own art supplies for infection control purposes. During each session participants will be allowed to self-select a subject matter or be provided with binary prompts to facilitate decision making. Participants will also have an option of displaying completed work in the reception area of the unit during their haemodialysis sessions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Over 18
• Receiving haemodialysis
• Physically and cognitively able to consent and take part in art activities

Exclusion Criteria

• Under 18
• Unable to read, write or speak English.
• Physically and cognitively unable to consent and take part in art activities.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

Helen Noble

Chief Investigator, Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen Noble, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Locations

Antrim Area Hospital Renal Unit

Antrim, , United Kingdom

Countries

United Kingdom

References

Carswell C, Reid J, Walsh I, Johnston W, McAneney H, Mullan R, Lee JB, Nelson H, Matthews M, Weatherup E, Spencer A, Michelo J, Quail A, Kielty G, Mackenzie A, Elliott J, Arbuckle N, Wilson A, Noble H. A mixed-methods feasibility study of an arts-based intervention for patients receiving maintenance haemodialysis. BMC Nephrol. 2020 Nov 19;21(1):497. doi: 10.1186/s12882-020-02162-4.

Reference Type: DERIVED

PMID: 33213413 (View on PubMed)

Carswell C, Reid J, Walsh I, McAneney H, Noble H. Implementing an arts-based intervention for patients with end-stage kidney disease whilst receiving haemodialysis: a feasibility study protocol. Pilot Feasibility Stud. 2019 Jan 5;5:1. doi: 10.1186/s40814-018-0389-y. eCollection 2019.

Reference Type: DERIVED

PMID: 30622728 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

B18-18

Identifier Type: -

Identifier Source: org_study_id