Peer support for late presenters
| ISRCTN | ISRCTN63482335 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63482335 |
| IRAS number | 204510 |
| Secondary identifying numbers | IRAS 204510, CPMS 32564 |
- Submission date
- 09/04/2023
- Registration date
- 19/04/2023
- Last edited
- 02/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
People with kidney disease find it reassuring and useful to talk to other patients with kidney disease. This is known as peer support. Research has shown that peer support can be particularly helpful when people are making decisions about kidney treatments. Unfortunately, some patients get very little time to be involved with these decisions because they are not known to kidney specialists until they urgently need treatment. This can make a carefully planned start on kidney dialysis difficult. As a result, these 'late presenters' often find it more difficult to adjust to life with kidney disease, have reduced or delayed access to a transplant and home dialysis, and have more medical problems. They might particularly benefit from peer support, but this has never been formally tried or tested. A full-scale test of the idea will be risky to set up because of the things that are not known. For example, it is not known whether it's possible to recruit enough peer supporters or exactly when and how late-presenting patients are able to or interested in receiving peer support. This study aims to answer these questions.
Who can participate?
Adult patients with established kidney disease
What does the study involve?
This study will answer the research questions by doing a 'test run' on a small number of late-presenting patients who will be offered regular contact with a peer supporter for four weeks. It will also explore how easy it is to measure the effects of peer support by asking the patients to complete questionnaires about their care and quality of life. We will compare their answers to those we get from patients who presented late but did not receive peer support. We also want patients to tell us in their own words how peer support has affected them and so will interview them.
What are the possible benefits and risks of participating?
Participation will help the development of peer support for kidney patients and inform how larger trials should look to investigate its benefits. Peer support is a social intervention so can’t harm participants in any physical way. There is a small chance that instead of finding peer support reassuring and helpful participants find it upsetting or makes them more anxious. Previous studies suggest that this is very unlikely.
Where is the study run from?
Kings College London (UK)
When is the study starting and how long is it expected to run for?
June 2015 to February 2018
Who is funding the study?
British Renal Society (UK)
Who is the main contact?
Eleri Wood, eleri.wood@nhs.net (UK)
Contact information
Principal Investigator
Kings College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
 ORCID ID |
0000-0002-5554-748X |
|---|---|
| Phone | +44 (0)203 2996233 |
| eleri.wood@nhs.net |
Public
Kings College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
| Phone | +44 (0)203 2996233 |
|---|---|
| eleri.wood@nhs.net |
Scientific
Kings College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
| Phone | +44 (0)203 2996233 |
|---|---|
| eleri.wood@nhs.net |
Study information
| Study design | Non-randomized pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital, Internet/virtual, Telephone |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A pilot study on the impact of peer support for people with advanced kidney failure presenting late to renal services |
| Study acronym | PS for LP |
| Study objectives | Peer support is a feasible treatment for people who start dialysis after presenting late to renal services |
| Ethics approval(s) | Approved 25/07/2016, London - Chelsea Research Ethics Committee (Royal Brompton Hospital, Sydney Street, London, SW3 6NP, UK; +44 (0)207 1048029; chelsea.rec@hra.nhs.uk), ref: 16/LO/1209 |
| Health condition(s) or problem(s) studied | Established kidney disease |
| Intervention | Peer support (once weekly for four weeks) with standard care versus standard care alone. Standard Care: Standard care after starting dialysis without preparation includes a nephrologist review within 1 week, support from a dialysis nurse 1-5 times weekly, a dietitian review, and the optional offer of counselling with a renal counsellor. The intervention: Standard care plus Peer support ie emotional or informational support delivered by experienced peer support workers (PSWs). PSWs are patients of the renal unit who themselves live with kidney disease; who have had 5 hours of in-house training to help them have the necessary understanding of the expectations and barriers of the role and basic communication skills; and who are registered King’s College Hospital volunteers. Delivered one-to-one. The initial peer support session is face-to-face at King’s College Hospital Renal Unit within two weeks of RRT start. A minimum of three further contacts (either face-to-face at the renal unit, by phone, or by email, at the preference of the participant) over the following three weeks. Allocation: Non-randomised. All eligible patients who consented in months 1-6 received standard care; those who consented in months 7-12 received the intervention. |
| Intervention type | Behavioural |
| Primary outcome measure | Acceptability measured using semi-structured interviews, with thematic analysis, at the 3 months follow up |
| Secondary outcome measures | 1. Biochemical/biological variables [blood pressure, Haemoglobin, potassium, phosphate, and calcium] measured using data recorded in the unit's database at baseline and 3-month follow-up 2. Treatment outcomes [dialysis modality, access, attendance/service use] measured using data recorded in the unit's database at 3-month follow-up 3. Patient-reported health-related quality of life outcomes measured using the EQ5D at baseline and 3 months 4. Patient activation measured using the Patient Activation Measure at baseline and 3 months |
| Overall study start date | 30/06/2015 |
| Completion date | 15/02/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 23 |
| Key inclusion criteria | 1. Aged over 18 years old 2. Commencing dialysis without preparation 3. Mental capacity to consent |
| Key exclusion criteria | 1. Lack of mental capacity 2. Acute kidney injury |
| Date of first enrolment | 16/10/2016 |
| Date of final enrolment | 15/10/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Denmark Hill
London
SE5 9RS
United Kingdom
Sponsor information
Hospital/treatment centre
Denmark Hill
London
SE5 9RS
England
United Kingdom
| Phone | None available |
|---|---|
| kch-tr.renal@nhs.net | |
"ROR" |
https://ror.org/01n0k5m85 |
Funders
Funder type
Research organisation
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- BRS
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publications planned of feasibility report and of analysis of qualitative data/patient experience |
| IPD sharing plan | The datasets generated and analysed during the study are available upon request from Eleri Wood (eleri.wood@nhs.net). Spreadsheets showing anonymized secondary data will be shared and will be available immediately. Eligible patients were approached and issued with study information while an inpatient or attending dialysis. Written informed consent was obtained at least 24 hours later. All data was anonymized. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
02/05/2023: Internal review.
19/04/2023: Trial's existence confirmed by Health Research Authority (HRA) (UK).
