Feasibility StudyNCT03629496
Developing an Arts-based Intervention for Patients With End-stage Kidney Disease Whilst Receiving Haemodialysis
A study testing Arts-based intervention in people with Feasibility Study and End Stage Renal Disease on Dialysis (Diagnosis), run by Queen's University, Belfast at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Feasibility Study, End Stage Renal Disease on Dialysis (Diagnosis)
- What is being tested?
- Arts-based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Sep 2018to 21 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18
- Receiving haemodialysis
- Physically and cognitively able to consent and take part in art activities
Who cannot join
- Under 18
- Unable to read, write or speak English.
- Physically and cognitively unable to consent and take part in art activities.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Arts-based intervention
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arts-based interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Seven months
Secondary outcomes (8)
Completion rate of Kidney Disease Quality of Life Short Form 36
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.
Measured: 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
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.
Measured: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant
Complete rate of missing data from Hospital Anxiety and Depression Scale
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.
Measured: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant.
Proportion of missing data from Hospital Anxiety and Depression Scale
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.
Measured: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant.
Completion rate of EuroQuol 5d 5l (EQ-5d-5l)
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.
Measured: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant
Proportion of missing data from EuroQuol 5d 5l (EQ-5d-5l)
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.
Measured: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant
Completion rate of Patient Service Use Log
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.
Measured: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant
Proportion of missing data from Patient Service Use Log
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.
Measured: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start3 Sep 2018
- Primary completion21 Jan 2019
- Study completion21 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Feasibility StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Noble, Queen's University, Belfast
- Investigators
- Helen Noble, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629496
- Sponsor's protocol ID
- B18-18
- Status last verified
- Mar 2019
- First submitted
- 23 Jul 2018
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33213413Carswell 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.
PubMed 30622728
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Arts-based Intervention for Patients With End-stage Kidney Disease Whilst Receiving Haemodialysis
- ClinicalTrials.gov ID
- NCT03629496
- Acronym / sponsor ID
- B18-18
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 21 Jan 2019 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Feasibility randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Arts-based intervention | Experimental | Other: Arts-based interventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18
- Receiving haemodialysis
- Physically and cognitively able to consent and take part in art activities
Key exclusion criteria (3 listed)
- Under 18
- Unable to read, write or speak English.
- Physically and cognitively unable to consent and take part in art activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arts-based intervention6x1 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. | Other | Arts-based intervention |
Primary outcome
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.
8 secondary outcomes
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
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
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.
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.
Completion rate of EuroQuol 5d 5l (EQ-5d-5l)
Time frame: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant
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
Completion rate of Patient Service Use Log
Time frame: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant
Proportion of missing data from Patient Service Use Log
Time frame: Data collection at baseline, 3 weeks, 6 weeks and 3 months per participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Derived from this study: PubMed 33213413Carswell 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.
- Derived from this study: PubMed 30622728Carswell 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Noble, PhD principal investigator
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arts-based intervention in people with Feasibility Study and End Stage Renal Disease on Dialysis (Diagnosis), run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and retention rates (time frame: Seven months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03629496, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.