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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03629496
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Helen Noble, Queen's University, Belfast

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.


Condition or disease Intervention/treatment Phase
Feasibility Study End Stage Renal Disease on Dialysis (Diagnosis) Other: Arts-based intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Feasibility randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Developing an Arts-based Intervention for Patients With End-stage Kidney Disease Whilst Receiving Haemodialysis
Actual Study Start Date : September 3, 2018
Actual Primary Completion Date : January 21, 2019
Actual Study Completion Date : January 21, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: 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.



Primary Outcome Measures :
  1. Recruitment and retention rates [ Time Frame: Seven months ]
    Amount of participants recruited into the study, and the amount of the participants who remain in the study until its conclusion.


Secondary Outcome Measures :
  1. Completion rate of Kidney Disease Quality of Life Short Form 36 [ Time Frame: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant ]
    The Kidney Disease Quality of Life Short Form 36 (KDQoL-SF36) is a disease specific quality of life measure, where higher scores represent better self-reported quality of life. This will be administered to determine whether it is an appropriate outcome measure for a definitive trial as determined by completion rates, the proportion of recruited participants who complete the questionnaire. As this is a feasibility study and is not statistically powered to establish an effect the scores from the KDQOL-SF 36 will not be used for hypothesis testing.

  2. Proportion of missing data from Kidney Disease Quality of Life Short Form 36 [ Time Frame: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant ]
    The Kidney Disease Quality of Life Short Form 36 (KDQoL-SF36) is a disease specific quality of life measure, where higher scores represent better self-reported quality of life. This will be administered to determine whether it is an appropriate outcome measure for a definitive trial as determined by proportion of missing data from the 36 total items included in the scale, per participant. As this is a feasibility study and is not statistically powered to establish an effect the scores from the KDQOL-SF 36 will not be used for hypothesis testing.

  3. Complete rate of missing data from Hospital Anxiety and Depression Scale [ Time Frame: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant. ]
    The Hospital Anxiety and Depression scale (HADS) is a scale that detects depression, anxiety and emotional distress in hospitalised patients, where higher values indicate a worse outcome. It will be administered to determine whether it is an appropriate outcome measure for a definitive trial as determined by completion rates, the proportion of recruited participants who complete the questionnaire. As this is a feasibility study and is not statistically powered to establish an effect the scores from the HADS will not be used for hypothesis testing.

  4. Proportion of missing data from Hospital Anxiety and Depression Scale [ Time Frame: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant. ]
    The Hospital Anxiety and Depression scale (HADS) is a scale that detects depression, anxiety and emotional distress in hospitalised patients, where higher values indicate a worse outcome. It will be administered to determine whether it is an appropriate outcome measure for a definitive trial as determined by proportion of missing data from the 14 total items included in the scale, per participant. As this is a feasibility study and is not statistically powered to establish an effect the scores from the HADS will not be used for hypothesis testing.

  5. Completion rate of EuroQuol 5d 5l (EQ-5d-5l) [ Time Frame: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant ]
    EuroQuol-5D-5L (EQ-5D-5L) is a standardised measure of health-related quality of life commonly used in economic evaluations to calculate cost-utility. The EQ-5D-5L will be administered to determine whether it is an appropriate outcome measure for a definitive trial (specifically for an economic evaluation) as determined by completion rates, the proportion of recruited participants who complete the questionnaire. As this is a feasibility study and is not statistically powered to establish an effect the scores from the EQ-5D-5L will not be used to calculate cost-utility of the intervention.

  6. Proportion of missing data from EuroQuol 5d 5l (EQ-5d-5l) [ Time Frame: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant ]
    EuroQuol-5D-5L (EQ-5D-5L) is a standardised measure of health-related quality of life commonly used in economic evaluations to calculate cost-utility. The EQ-5D-5L will be administered to determine whether it is an appropriate outcome measure for a definitive trial (specifically for an economic evaluation) as determined by proportion of missing data from the 6 total items included in the scale. As this is a feasibility study and is not statistically powered to establish an effect the scores from the EQ-5D-5L will not be used to calculate cost-utility of the intervention.

  7. Completion rate of Patient Service Use Log [ Time Frame: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant ]
    A Patient Service Use Log will be administered to determine whether it is an appropriate method to capture healthcare resource use data for an economic evaluation within a definitive trial as determined by completion rates , the proportion of recruited participants who complete the log. As this is a feasibility study and is not statistically powered to establish an effect the data from the Patient Resource Use log will not be used to calculate cost-utility of the intervention.

  8. Proportion of missing data from Patient Service Use Log [ Time Frame: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant ]
    A Patient Service Use Log will be administered to determine whether it is an appropriate method to capture healthcare resource use data for an economic evaluation within a definitive trial as determined by proportion of missing data per participant. As this is a feasibility study and is not statistically powered to establish an effect the data from the Patient Resource Use log will not be used to calculate cost-utility of the intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629496


Locations
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United Kingdom
Antrim Area Hospital Renal Unit
Antrim, United Kingdom, BT41 2RL
Sponsors and Collaborators
Queen's University, Belfast
Investigators
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Principal Investigator: Helen Noble, PhD Queen's University, Belfast
  Study Documents (Full-Text)

Documents provided by Helen Noble, Queen's University, Belfast:
Study Protocol  [PDF] July 10, 2018
Statistical Analysis Plan  [PDF] August 1, 2018
Informed Consent Form  [PDF] July 5, 2018


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helen Noble, Chief Investigator, Lecturer, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT03629496    
Other Study ID Numbers: B18-18
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency