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

NCT03629496 | Completed

• 1 other identifier: B18-18
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Recruitment and retention rates

  Amount of participants recruited into the study, and the amount of the participants who remain in the study until its conclusion.

  Seven months

Secondary Outcomes (8)

• Completion rate of Kidney Disease Quality of Life Short Form 36

  Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant

• Proportion of missing data from Kidney Disease Quality of Life Short Form 36

  Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant

• Complete rate of missing data from Hospital Anxiety and Depression Scale

  Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant.

• Proportion of missing data from Hospital Anxiety and Depression Scale

  Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant.

• Completion rate of EuroQuol 5d 5l (EQ-5d-5l)

  Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant

Study Arms (2)

Arts-based intervention

EXPERIMENTAL

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.

Other: Arts-based intervention

Control

NO INTERVENTION

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.

Interventions

Arts-based intervention 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.

Arts-based intervention

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (1)

Antrim Area Hospital Renal Unit

Antrim, BT41 2RL, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 33213413 DERIVED

• 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.

  PMID: 30622728 DERIVED

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Helen Noble, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator, Lecturer

Model Details: Feasibility randomised controlled trial

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 14, 2018
• Study Start: September 3, 2018
• Primary Completion: January 21, 2019
• Study Completion: January 21, 2019
• Last Updated: March 20, 2019

Record last verified: 2019-03

Locations

GB (1)