Bathing adaptations in the homes of older adults 2
| ISRCTN | ISRCTN48563324 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48563324 |
| IRAS number | 290805 |
| Secondary identifying numbers | CPMS 48800, IRAS 290805 |
- Submission date
- 09/04/2021
- Registration date
- 22/04/2021
- Last edited
- 23/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Background and study aims
Sometimes older people may become unable to use the bath or shower at home because it is difficult to get in and out of. An occupational therapist may recommend that they have a ‘walk- in’ shower put in. This may enable the person to continue to manage their personal care without help. It may also make it less likely that they have an accident or fall. However, there is limited research on how walk-in showers may help people to manage their personal care as they get older. We want to find out whether having a walk-in shower improves or maintains older people’s health, safety, quality of life, and ability to manage their personal care. We want to answer two important questions: is the provision of walk-in showers effective? If so, is quicker provision more effective?
Who can participate?
People aged 60 and over, who have been referred to the participating council’s adaptations service for a walk-in shower, will be invited to join the study.
What does the study involve?
We will randomly allocate half to begin the process for walk-in shower installation straight away (intervention group). The other half will go on the usual waiting list (control group) which can be between 4 and 9 months before the shower is put in. We will compare the two groups 4 weeks after the intervention group has received their showers. We will also compare the groups again 4 and 12 weeks after the control group has received their showers. We want to see whether those who had to wait for their shower to be put in have more long-term difficulties with everyday activities, and whether they need more help from family, or health and social care services. As an additional part of the study, we will carry out interviews about the bathing adaptations process with people using the service and social care and housing professionals; and a survey of all local authorities with social care responsibilities.
What are the possible benefits and risks of participating?
There may be no direct benefit to participants. The information we get from this study will help to determine how to organise adaptations services in the future. The study aims to help social care and housing staff best use the resources available to them when treating people in their own homes.
Where is the study run from?
The research is being organised by Newcastle University and York Trials Unit at the University of York (UK)
When is the study starting and how long is it expected to run for?
December 2020 to May 2024
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Dr Phillip Whitehead
Phillip.Whitehead@newcastle.ac.uk
Contact information
Dr Phillip Whitehead
Scientific
Scientific
Newcastle University
Population Health Sciences Institute
Campus for Ageing and Vitality
Westgate Road
Newcastle upon Tyne
NE4 6BE
United Kingdom
| Phillip.Whitehead@newcastle.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Bathing adaptations in the homes of older adults: a randomized controlled trial, economic evaluation and process evaluation – the BATH-OUT 2 trial |
| Study acronym | BATH-OUT 2 |
| Study objectives | Earlier provision bathing adaptations will lead to improvements in their health and social care related quality of life. Our secondary hypothesis is that earlier and more rapid provision of bathing adaptations will lead to greater improvements in health and social care related quality of life. |
| Ethics approval(s) | Approved 09/03/2021, London - Camberwell St Giles Research Ethics Committee ( Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, UK; +44 (0)207 104 8340; camberwellstgiles.rec@hra.nhs.uk), ref: 21/LO/0044 |
| Health condition(s) or problem(s) studied | Bathing adaptations in the homes of older adults |
| Intervention | Current interventions as of 13/07/2023: Participants will be randomly allocated 1:1 to the usual care or intervention group. We will use “pairwise” randomisation. The randomisation will be stratified by ability to complete the SF-36; for those participants who can self-complete the SF-36, it will be further stratified by site and property tenure, and for those who can not, it will be stratified by site only. Additional flexibility of the strata will be considered in cases where finding a pair is problematic. The randomisation sequence will be generated by a statistician at York Trials Unit. Study groups: Control: Usual waiting list group. People in this group will remain on the usual waiting list and be allocated to a project officer surveyor to begin the adaptations process when they reach the top of the waiting list and/or by the usual processes and timescales within the local authority. The waiting list at our sites before the COVID-19 pandemic was between 4 and 9 months, but this can vary. Intervention: Accelerated list group. People in this group will be allocated to a project officer/surveyor to begin the adaptations process and/or will have their adaptations process expedited by active management of the process and rapid or fast-tracked contracting. Baseline consultation: Local authority staff will contact people who have been referred for an accessible shower to let them know they have been added to a waiting list for this. If the person fulfils the eligibility criteria the administrator will also give a brief overview of the study and ask permission for a research assistant to make contact with them about the study and to send further information. If a participant requires consultee support either a personal or nominated consultee will attempt to be identified. Additionally, if the participant is unable to answer the questions, an “alternative participant” will be recruited. We will seek advice from the trial participant and the consultee about the most appropriate person to act as an “alternative participant”. The research assistant will telephone the potential participant and/or a consultee and answer any questions they have about the study. The research assistant will also complete a screening form to confirm eligibility. If the potential participant/consultee wants to take part in the study at this initial contact they will undergo the consent process. If they are still undecided after the initial consultation the research assistant will arrange to contact them within a timescale agreed with the potential participant, leaving at least 24 hours since the previous consultation. After informed consent is gained the participant or “alternative participant” will complete a baseline questionnaire. Follow-up: The time points at which participants will be followed-up will be based on the completion of the walk-in shower installation. For each randomised pair, participant follow-up data will be collected at three time points: (1) 4 weeks after the intervention participant receives their bathing adaptation, (2) 4 weeks after the control participant receives their bathing adaptation, and (3) 12 weeks after the control participant receives their bathing adaptation. Participants will be sent a ‘diary’ sheet following the first follow-up visit and after each subsequent follow up visit to enable them to record contacts with health, social care and other services. This diary will be optional, for them to complete at home. The purpose is to aid their recall where there is a longer time period between each follow up. The diary will not be returned to the research team. Follow-up data collection is likely to be conducted using remote methods to ensure the safety of participants and research assistants. However, if possible, we will offer face-to-face visits to participants’ homes if circumstances change during the study. Internal Pilot Phase: During the first six months of the study we will assess the progress of the study in terms of recruitment and questionnaire completion to identify any whether any modifications need to be made to the study. Process evaluation: We will undertake a mixed methods process evaluation comprised of interviews with stakeholders and a survey of local authorities with social care responsibilities in England. National survey of local authorities: The survey will focus on understanding providers’ experiences of implementing bathing adaptations in order to understand the determinants of provision of adaptations. _____ Previous interventions as of 27/07/2021: Participants will be randomly allocated 1:1 to the usual care or intervention group. We will use “pairwise” randomisation. The randomisation will be stratified by ability to complete the SF-36; for those participants who can self-complete the SF-36, it will be further stratified by site and property tenure, and for those who can not, it will be stratified by site only. Additional flexibility of the strata will be considered in cases where finding a pair is problematic. The randomisation sequence will be generated by a statistician at York Trials Unit. Study groups: Control: Usual waiting list group. People in this group will remain on the usual waiting list and be allocated to a project officer surveyor to begin the adaptations process when they reach the top of the waiting list and/or by the usual processes and timescales within the local authority. The waiting list at our sites before the COVID-19 pandemic was between 4 and 9 months, but this can vary. Intervention: Accelerated list group. People in this group will be allocated to a project officer/surveyor to begin the adaptations process and/or will have their adaptations process expedited by active management of the process and rapid or fast-tracked contracting. Baseline consultation: Local authority staff will contact people who have been referred for an accessible shower to let them know they have been added to a waiting list for this. If the person fulfils the eligibility criteria the administrator will also give a brief overview of the study and ask permission for a research assistant to make contact with them about the study and to send further information. If a participant requires consultee support either a personal or nominated consultee will attempt to be identified. Additionally, if the participant is unable to answer the questions, an “alternative participant” will be recruited. We will seek advice from the trial participant and the consultee about the most appropriate person to act as an “alternative participant”. The research assistant will telephone the potential participant and/or a consultee and answer any questions they have about the study. The research assistant will also complete a screening form to confirm eligibility. If the potential participant/consultee wants to take part in the study at this initial contact they will undergo the consent process. If they are still undecided after the initial consultation the research assistant will arrange to contact them within a timescale agreed with the potential participant, leaving at least 24 hours since the previous consultation. After informed consent is gained the participant or “alternative participant” will complete a baseline questionnaire. Follow-up: The time points at which participants will be followed-up will be based on the completion of the walk-in shower installation. For each randomised pair, participant follow-up data will be collected at four time points: (1) 4 weeks after the intervention participant receives their bathing adaptation, (2) 2 weeks before the control participant receives their bathing adaptation, (3) 4 weeks after the control participant receives their bathing adaptation, and (4) 12 weeks after the control participant receives their bathing adaptation. Participants will be sent a ‘diary’ sheet following the first follow-up visit and after each subsequent follow up visit to enable them to record contacts with health, social care and other services. This diary will be optional, for them to complete at home. The purpose is to aid their recall where there is a longer time period between each follow up. The diary will not be returned to the research team. Follow-up data collection is likely to be conducted using remote methods to ensure the safety of participants and research assistants. However, if possible, we will offer face-to-face visits to participants’ homes if circumstances change during the study. Internal Pilot Phase: During the first six months of the study we will assess the progress of the study in terms of recruitment and questionnaire completion to identify any whether any modifications need to be made to the study. Process evaluation: We will undertake a mixed methods process evaluation comprised of interviews with stakeholders and a survey of local authorities with social care responsibilities in England. National survey of local authorities: The survey will focus on understanding providers’ experiences of implementing bathing adaptations in order to understand the determinants of provision of adaptations. _____ Previous interventions: Participants will be randomly allocated 1:1 to the usual care or intervention group. We will use “pairwise” randomisation. The randomisation will be stratified by ability to complete the SF-36; for those participants who can self-complete the SF-36, it will be further stratified by site and property tenure, and for those who can not, it will be stratified by site only. Additional flexibility of the strata will be considered in cases where finding a pair is problematic. The randomisation sequence will be generated by a statistician at York Trials Unit. Study groups: Control: Usual waiting list group. People in this group will remain on the usual waiting list and will be allocated to a project officer to plan their walk-in shower when they come to the top of the list. The waiting list at our sites before the COVID-19 pandemic was between 4 and 9 months, but this can vary. Intervention: Accelerated list group. People in this group will be allocated to a project officer to plan their walk-in shower as soon as possible. Baseline consultation: Local authority staff will contact people who have been referred for an accessible shower to let them know they have been added to a waiting list for this. If the person fulfils the eligibility criteria the administrator will also give a brief overview of the study and ask permission for a research assistant to make contact with them about the study and to send further information. If a participant requires consultee support either a personal or nominated consultee will attempt to be identified. Additionally, if the participant is unable to answer the questions, an “alternative participant” will be recruited. We will seek advice from the trial participant and the consultee about the most appropriate person to act as an “alternative participant”. The research assistant will telephone the potential participant and/or a consultee and answer any questions they have about the study. The research assistant will also complete a screening form to confirm eligibility. If the potential participant/consultee wants to take part in the study at this initial contact they will undergo the consent process. If they are still undecided after the initial consultation the research assistant will arrange to contact them within a timescale agreed with the potential participant, leaving at least 24 hours since the previous consultation. After informed consent is gained the participant or “alternative participant” will complete a baseline questionnaire. Follow-up: The time points at which participants will be followed-up will be based on the completion of the walk-in shower installation. For each randomised pair, participant follow-up data will be collected at four time points: (1) 4 weeks after the intervention participant receives their bathing adaptation, (2) 2 weeks before the control participant receives their bathing adaptation, (3) 4 weeks after the control participant receives their bathing adaptation, and (4) 12 weeks after the control participant receives their bathing adaptation. Participants will be sent a ‘diary’ sheet following the first follow-up visit and after each subsequent follow up visit to enable them to record contacts with health, social care and other services. This diary will be optional, for them to complete at home. The purpose is to aid their recall where there is a longer time period between each follow up. The diary will not be returned to the research team. Follow-up data collection is likely to be conducted using remote methods to ensure the safety of participants and research assistants. However, if possible, we will offer face-to-face visits to participants’ homes if circumstances change during the study. Internal Pilot Phase: During the first six months of the study we will assess the progress of the study in terms of recruitment and questionnaire completion to identify any whether any modifications need to be made to the study. Process evaluation: We will undertake a mixed methods process evaluation comprised of interviews with stakeholders and a survey of local authorities with social care responsibilities in England. National survey of local authorities: The survey will focus on understanding providers’ experiences of implementing bathing adaptations in order to understand the determinants of provision of adaptations. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measure as of 13/07/2023: Physical Component Summary score (PCS) of the SF-36 measured in: 1. Both groups at baseline 2. Four weeks post-adaptation in the intervention group 3. Four weeks post-adaptation in control group 4. 12 weeks post-adaptation in control group _____ Previous primary outcome measure: Physical Component Summary score (PCS) of the SF-36 measured in: 1. Both groups at baseline 2. Four weeks post-adaptation in the intervention group 3. Two weeks pre-adaptation in control group 4. Four weeks post-adaptation in control group 5. 12 weeks post-adaptation in control group |
| Secondary outcome measures | Current secondary outcome measures as of 13/07/2023: 1. Perceived mental health status measured via the Mental Component Summary score (MCS) of the SF-36 measured at the above timepoints. 2. Number of falls (self reported) measured at baseline, four weeks post-adaptation in the intervention group, 4 weeks post-adaptation in control group and 12 weeks post-adaptation in control group. 3. Health and social care service use and associated costs measured at baseline, four weeks post-adaptation in the intervention group, 4 weeks post-adaptation in control group and 12 weeks post-adaptation in control group. 4. Health related quality of life using the EuroQol EQ-5D-5L measured at baseline, four weeks post-adaptation in the intervention group, 4 weeks post-adaptation in control group and 12 weeks post-adaptation in control group. 5. Social care related quality of life using the Adult Social Care Outcomes Toolkit (ASCOT) measured at baseline, four weeks post-adaptation in the intervention group, 4 weeks post-adaptation in control group and 12 weeks post-adaptation in control group. 6. Perceived risk of falling (Short falls efficacy scale) measured at baseline, four weeks post-adaptation in the intervention group, 4 weeks post-adaptation in control group and 12 weeks post-adaptation in control group. 7. Independence in bathing (bathing question of the Barthel Index) measured at baseline, four weeks post-adaptation in the intervention group, 4 weeks post-adaptation in control group and 12 weeks post-adaptation in control group. 8. Ability to manage personal activities of daily living (Barthel Index) measured at baseline, four weeks post-adaptation in the intervention group, 4 weeks post-adaptation in control group and 12 weeks post-adaptation in control group. 9. Perceived difficulty in bathing (0-100 scale) measured at baseline, four weeks post-adaptation in the intervention group, 4 weeks post-adaptation in control group and 12 weeks post-adaptation in control group. _____ Previous secondary outcome measures: 1. Perceived mental health status measured via the Mental Component Summary score (MCS) of the SF-36 measured at the above timepoints. 2. Number of falls (self reported) measured at baseline, four weeks post-adaptation in the intervention group, 2 weeks pre-adaptation in control group, 4 weeks post-adaptation in control group and 12 weeks post-adaptation in control group. 3. Health and social care service use and associated costs measured at baseline, four weeks post-adaptation in the intervention group, 2 weeks pre-adaptation in control group, 4 weeks post-adaptation in control group and 12 weeks post-adaptation in control group. 4. Health related quality of life using the EuroQol EQ-5D-5L measured at baseline, four weeks post-adaptation in the intervention group, 2 weeks pre-adaptation in control group, 4 weeks post-adaptation in control group and 12 weeks post-adaptation in control group. 5. Social care related quality of life using the Adult Social Care Outcomes Toolkit (ASCOT) measured at baseline, four weeks post-adaptation in the intervention group, 4 weeks post-adaptation in control group and 12 weeks post-adaptation in control group. 6. Perceived risk of falling (Short falls efficacy scale) measured at baseline, four weeks post-adaptation in the intervention group, 4 weeks post-adaptation in control group and 12 weeks post-adaptation in control group. 7. Independence in bathing (bathing question of the Barthel Index) measured at baseline, four weeks post-adaptation in the intervention group, 4 weeks post-adaptation in control group and 12 weeks post-adaptation in control group. 8. Ability to manage personal activities of daily living (Barthel Index) measured at baseline, four weeks post-adaptation in the intervention group, 4 weeks post-adaptation in control group and 12 weeks post-adaptation in control group. 9. Perceived difficulty in bathing (0-100 scale) measured at baseline, four weeks post-adaptation in the intervention group, 4 weeks post-adaptation in control group and 12 weeks post-adaptation in control group. |
| Overall study start date | 01/12/2020 |
| Completion date | 31/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 60 Years |
| Sex | Both |
| Target number of participants | 272 |
| Total final enrolment | 299 |
| Key inclusion criteria | Current inclusion criteria as of 13/07/2023: 1. People aged 60 years or over 2. People referred for a major adaptation for provision of an accessible (level or easy access) showering facility. This may be by removal of an existing bath or shower cubicle. 3. People living in housing owned by the local authority or living in privately-owned housing (owner-occupied, privately rented, housing association owned) and appear to be eligible for a Disabled Facilities Grant (DFG) and/or assistance from the local authority. The study will include people who do not speak English and will provide interpreters. The researchers will use the interpreting agency at the site. _____ Previous inclusion criteria as of 27/07/2021: 1. People aged 65 years or over 2. People referred for a major adaptation for provision of an accessible (level or easy access) showering facility. This may be by removal of an existing bath or shower cubicle. 3. People living in housing owned by the local authority or living in privately-owned housing (owner-occupied, privately rented, housing association owned) and appear to be eligible for a Disabled Facilities Grant (DFG) and/or assistance from the local authority. The study will include people who do not speak English and will provide interpreters. The researchers will use the interpreting agency at the site. _____ Previous inclusion criteria: 1. People aged 65 years or over 2. People referred for a major adaptation for provision of an accessible (level or easy access) showering facility. This may be by removal of an existing bath or shower cubicle. 3. People living in housing owned by the local authority or living in privately-owned housing (owner-occupied, privately rented, housing association owned) and appear to be eligible for a Disabled Facilities Grant (DFG) The study will include people who do not speak English and will provide interpreters. The researchers will use the interpreting agency at the site. |
| Key exclusion criteria | 1. People referred for an accessible showering facility plus one or more other adaptations (e.g. ramps, hoists, lifts) as these adaptations are more complex and will involve extended timescales 2. People referred for a rapid, fast-tracked or urgent priority bathing adaptation 3. People who lack the mental capacity to provide informed consent and we are unable to identify a personal or nominated consultee 4. People who lack the mental capacity to provide informed consent and who are unable to provide any study outcomes with support or where we are unable to identify an “alternative participant” to provide data |
| Date of first enrolment | 14/09/2021 |
| Date of final enrolment | 31/08/2023 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Not provided at time of registration (no centres confirmed yet)
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-
-
United Kingdom
-
-
United Kingdom
Sponsor information
Newcastle University
University/education
University/education
c/o Kay Howes
Head of Faculty Research
Faculty of Medical Sciences
Newcastle University
Newcastle upon Tyne
NE1 7RU
England
United Kingdom
| sponsorship@newcastle.ac.uk | |
"ROR" |
https://ror.org/01kj2bm70 |
Funders
Funder type
Government
National Institute for Health Research (NIHR); Grant Codes: 102645/T19-034/UN-P151
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We anticipate producing four high-quality, high-impact peer reviewed papers. We will seek to publish the study protocol, the main RCT findings and cost effectiveness findings and an additional complementary health economics paper which will involve further exploration of EQ5D and ASCOT QALYs within one year after study completion. We will also publish the findings from the interviews and the survey of local authorities. We will co-produce a brief Plain English Summary of the study results with our PPI group and distribute this to participants at the end of the study. We will also produce the requisite NIHR SSCR academic and administrative reports, within the agreed timescales. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be available upon reasonable request from the Chief Investigator (phillip.whitehead@northumbria.ac.uk) following completion of the trial and publication of trial results. Requests will be considered by the Trial Management Group on a case-by-case basis. Data will be made available for secondary analyses, and only anonymised data will be provided. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 22/01/2024 | 23/01/2024 | Yes | No |
Editorial Notes
23/01/2024: Publication reference added.
19/12/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2023 to 31/08/2023.
2. The overall study end date was changed from 30/04/2025 to 31/05/2024.
3. The intention to publish date was changed from 30/04/2025 to 31/10/2024.
4. Total final enrolment added.
13/07/2023: The following changes were made to the trial record:
1. The interventions were changed.
2. The primary outcome measure was changed.
3. The secondary outcome measures were changed.
4. The overall end date was changed from 31/10/2023 to 30/04/2025.
5. The inclusion criteria were changed.
6. The target number of participants was changed from 360 to 272.
7. The recruitment end date was changed from 01/06/2022 to 31/12/2023.
8. The intention to publish date was changed from 01/07/2024 to 30/04/2025.
9. The plain English summary was updated to reflect these changes.
17/09/2021: The recruitment start date has been changed from 01/06/2021 to 14/09/2021.
27/07/2021: The following changes were made to the trial record:
1. The contact details, interventions and exclusion criteria were updated.
2. The sponsor was changed from Northumbria University to Newcastle University.
3. The overall trial end date was changed from 31/07/2023 to 31/10/2023.
09/04/2021: Trial's existence confirmed by the NIHR.
