Preliminary evaluation of the ‘Living Well on Haemodialysis’ programme
| ISRCTN | ISRCTN10070371 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10070371 |
| Secondary identifying numbers | ETH2122-0671 |
- Submission date
- 18/02/2022
- Registration date
- 23/02/2022
- Last edited
- 02/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Hemodialysis is a process used to purify the blood of a person whose kidneys are not working normally. It can extend the lives of people with end-stage kidney disease, but it is an extremely burdensome, invasive treatment that imposes significant limitations and restrictions on the lives of the people receiving it. It is therefore important to find the most effective ways to support people receiving dialysis to maintain their wellbeing and quality of life in spite of the difficulties it creates for them. Acceptance and Commitment Therapy (ACT) is a mindfulness-based therapy designed to enable people to lead rich, meaningful lives while accepting the pain and suffering of life. ACT uses metaphor, paradox, mindfulness skills and experiential exercises to promote psychological flexibility, which involves being open, aware and in contact with the present moment, and engaging in activities consistent with one’s goals and values. ACT has been shown to be useful for people with a range of physical conditions, and a set of ACT-based materials and exercises were recently adapted specifically for people receiving dialysis and presented as a series of short videos (the published report of the adaptation exercise is available here: https://doi.org/10.1186/s12894-021-00921-5). The aim of this study is to assess how feasible a programme of those materials is and whether the materials are acceptable to people with chronic kidney disease who are receiving in-centre haemodialysis. The researchers will use the results of this small preliminary trial to prepare for a larger, randomised controlled trial.
Who can participate?
Patients aged over 18 years of age with chronic kidney disease who received in-centre haemodialysis for at least 90 days in the last 2 years and who are able to converse in English.
What does the study involve?
Talking part in the study involves completing some questionnaires and then spending about an hour a week over 4 weeks, trying out a programme of exercises and materials in the form of short films. The programme is called ‘Living Well on Haemodialysis’. Each week there are four short films to watch – one story film, in which a person with chronic kidney disease talks about their own experience of dialysis and the techniques they found helped them to live better with dialysis, and three explainer films, which explain how to use the techniques described in the story film. All participants receive the same treatment. There will be a focus group for participants to talk about their experience of following the programme. After the programme and 4 weeks later, participants will complete similar questionnaires as those presented before the programme.
What are the possible benefits and risks of participating?
It is hoped that participants will find taking part interesting and they may learn some techniques to help them live better on dialysis. The researchers will use the results of the trial to improve the materials further and make them more widely available so that we hope larger numbers of people in the future will benefit from participants’ involvement. As a gesture of appreciation for the time and effort involved, people who complete all the stages of the study will receive a £30 shopping voucher.
There is a small risk that participants might find the content of the videos mildly distressing because they involve discussion about people encountering challenges and difficulties associated with kidney disease and dialysis, and then finding ways to overcome those challenges and difficulties in order to feel better about dialysis and get more benefits from the treatment.
Where is the study run from?
University of Derby (UK)
When is the study starting and how long is it expected to run for?
September 2021 to April 2022
Who is funding the study?
1. Kidney Care UK and the British Renal Society.
2. University of Derby (UK)
Who is the main contact?
Prof. James Elander
j.elander@derby.ac.uk
Contact information
Principal Investigator
School of Psychology
University of Derby
Kedleston Road
Derby
DE22 1GB
United Kingdom
 ORCID ID |
0000-0001-7665-5482 |
|---|---|
| Phone | +44 (0)1332 593048 |
| j.elander@derby.ac.uk |
Study information
| Study design | Single-centre single-group before-and-after trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet |
| Scientific title | Feasibility and acceptability trial of intervention materials based on Acceptance and Commitment Therapy for people receiving in-centre renal haemodialysis |
| Study acronym | ACT-for-dialysis |
| Study hypothesis | The objectives are to: 1. Assess the feasibility of recording recruitment, retention, fidelity, adherence and adverse events during participation. 2. Assess the acceptability of the materials by collecting direct evaluative feedback. 3. Explore participants’ experiences of the materials using focus groups. 4. Inform the design of a larger-scale randomised controlled trial by collecting pilot data on changes in primary and secondary outcome measures. |
| Ethics approval(s) | Approved 08/11/2021, University of Derby Health, Psychology and Social Care Research Ethics Committee (Kedleston Road, Derby, DE22 1GB, UK; +44 (0) 1332 590500; hpsccrec@derby.ac.uk), ref: ETH2122-0671 |
| Condition | Improvement of quality of life among people with end-stage renal disease receiving in-centre haemodialysis |
| Intervention | Single-group before-and-after study, with baseline (pre-intervention) measures, then a 4-week intervention programme, post-intervention measures and 4-week post-intervention follow-up. Talking part in the study involves completing some questionnaires and then spending about an hour a week over 4 weeks trying out a programme of exercises and materials in the form of short films. The programme is called ‘Living Well on Haemodialysis’. Each week there are four short films to watch – one story film, in which a person with chronic kidney disease talks about their own experience of dialysis and the techniques they found helped them to live better with dialysis, and three explainer films, which explain how to use the techniques described in the story film. All participants receive the same treatment. There will be a focus group for participants to talk about their experience of following the programme. After the programme and 4 weeks later, participants will complete similar questionnaires as those presented before the programme, including the Illness Acceptance Questionnaire, the Acceptance and Action Questionnaire, and the Kidney Disease Quality of Life questionnaire. |
| Intervention type | Behavioural |
| Primary outcome measure | Physical, mental and kidney disease-specific quality of life, measured using the Kidney Disease Quality of Life Short Form (KDQOLSF) at baseline, 4 weeks (post intervention) and 8 weeks (4-week post intervention follow-up) |
| Secondary outcome measures | 1. Psychological flexibility measured using the Acceptance and Action Scale at baseline (pre-intervention), 4 weeks (post-intervention) and 8 weeks (4-week post-intervention follow-up) 2. Acceptance of illness measured using the Acceptance of Illness Scale at baseline, (pre-intervention), 4 weeks (post-intervention) and 8 weeks (4-week post-intervention follow-up) 3. Feasibility assessed by recording recruitment and retention, plus fidelity, adherence and adverse events during the intervention and post-intervention 4. Acceptability assessed by collecting direct evaluative feedback using ratings scales and free-text open response formats, plus a focus group, to assess how participants experienced the intervention at post-intervention |
| Overall study start date | 01/09/2021 |
| Overall study end date | 11/04/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 10 |
| Total final enrolment | 13 |
| Participant inclusion criteria | 1. Age over 18 years 2. Received in-centre dialysis for at least 90 days in the last 2 years 3. Able to converse in English |
| Participant exclusion criteria | 1. Not able to use the intervention because of a medical condition, active infection or malignancy 2. Unable or unwilling to give informed consent 3. Unable to take part in online data collection because of technical limitations |
| Recruitment start date | 01/02/2022 |
| Recruitment end date | 30/04/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Derby
DE22 1GB
United Kingdom
Sponsor information
University/education
Kedleston Road
Derby
DE2 1GB
England
United Kingdom
| Phone | +44 (0)1332 593044 |
|---|---|
| j.montague@derby.ac.uk | |
| Website | https://www.derby.ac.uk/ |
"ROR" |
https://ror.org/02yhrrk59 |
Funders
Funder type
University/education
No information available
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 28/02/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed high-impact journal, and dissemination to a network of clinical researchers and practitioners. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Prof. James Elander (j.elander@derby.ac.uk). This data will be available from between Summer 2022 and December 2022, depending on the time needed to prepare, anonymise and review the datasets to ensure they are consistent with participants’ consent. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Dataset | 04/09/2023 | No | No | ||
| Dataset | 04/09/2023 | No | No | ||
| Statistical Analysis Plan | 04/09/2023 | No | No | ||
| Results article | 01/10/2023 | 02/10/2023 | Yes | No |
Additional files
Editorial Notes
02/10/2023: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
04/09/2023: The following changes were made:
1. Statistical analysis plan uploaded.
2. Patient engagement and interview datasets uploaded.
27/10/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/06/2022 to 11/04/2022.
2. The intention to publish date was changed from 30/12/2022 to 28/02/2023.
3. The plain English summary was updated to reflect these changes.
23/02/2022: Trial's existence confirmed by the Kidney Care UK and British Renal Society Joint Grants Partnership.
