MedTrace Logo

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

NCT03629496 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-03-20

No results posted yet for this study

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)

Interventions

OTHER

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.

Sponsors & Collaborators

  • Queen's University, Belfast

    lead OTHER

Principal Investigators

  • Helen Noble, PhD · Queen's University, Belfast

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-03
Primary Completion
2019-01-21
Completion
2019-01-21

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03629496 on ClinicalTrials.gov