A cluster randomised controlled trial of an occupational therapy intervention for residents with stroke living in UK care-homes
| ISRCTN | ISRCTN00757750 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00757750 |
| Secondary identifying numbers | HTA 08/14/30 |
- Submission date
- 17/10/2009
- Registration date
- 21/10/2009
- Last edited
- 02/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
This 4 year-long study is being carried out to assess the value of providing a targeted course of occupational therapy to people living in a residential or nursing home after stroke. This service has been found to be of value to people living in their own homes, and to people after a stroke. It has been found to be helpful in terms of improving their independence, their ability to take part in everyday activities, and their mobility. However, occupational therapy is less readily available to people living in residential or nursing homes.
Who can participate?
Residents of care/residential homes of any age, with a history of stroke or transient ischaemic attack (TIA).
What does the study involve?
All the homes that participate in the study will either receive the service of an occupational therapist or not for a three month period (on top of any services the home currently receives).
If the participant decides to take part, he/she will be assessed four times-at 0 months, 3 months, 6 months and finally at 12 months. The participant may be seen by an occupational therapist, who will deliver therapy according to his/her needs. The assessments will ask the participant various questions about his/her day to day activities. The initial assessments will also look at his/her communication and clarity of thought.
The therapists providing the service will ask the participant their ability to take part in day to day activities and, if the therapist feels that he/she can help the participant to keep their mobility and or prevent them from losing their independence, they will suggest one of a number of things to help. This may include:
1. Providing a piece of equipment or adapting something (such as raising the height of their chair)
Providing advice
2. Providing activities, which he/she will practice with the participant and ask him/her to continue to practice between visits
3. Providing exercises for him/her to practice.
The therapists will arrange a time that is convenient for the participant and this will not restrict their lifestyle in any way. The therapists providing the therapy would be visiting the care/nursing home for about 3 months, but as an individual the participant may only be seen a few times (depending on his/her needs).
What are the possible benefits and risks of participating?
It is hoped that we can show that the services of an occupational therapist would be helpful to people living in either residential or nursing homes after a stroke. However, this cannot be guaranteed. The information collected from this study may help us to assist people participate in day to day activities more easily and maintain this ability for a longer period of time. The services of an occupational therapist are not thought to put individuals at risk. The therapists would not ask the participant to do things that they don't want to and they are free to stop at any time. At worst, the services the therapist offers may not have any measurable benefits.
Where is the study run from?
University of Birmingham at the Primary Care Clinical Research & Trials Unit (UK)
When is the study starting and how long is it expected to run for?
January 2010 to February 2013
Who is funding the study?
NIHR - Health Technology Assessment (HTA) (UK)
Who is the main contact?
Prof. Catherine Sackley
C.Sackley@uea.ac.uk
Contact information
Scientific
University of Birmingham
Primary Care Clinical Sciences
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 4144198 |
|---|---|
| c.m.sackley@bham.ac.uk |
Study information
| Study design | Pragmatic phase III cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A cluster randomised controlled trial of an occupational therapy intervention for residents with stroke living in UK care-homes |
| Study acronym | OTCH |
| Study objectives | The purpose of the study is to conduct a phase III randomised controlled trial (RCT) to evaluate the effects of a targeted course of occupational therapy (targeted repetitive training of activities of daily living, provision of adaptive equipment and minor environmental adaptations and staff training) for people with stroke living in a care home. In particular, the effects on: 1. Independence in self-care activities of daily living 2. Mobility Adverse events will be recorded. An economic evaluation will be conducted More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/081430 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0017/52361/PRO-08-14-30.pdf |
| Ethics approval(s) | Submitted via Integrated Research Application System (IRAS) on 07/10/2009 (ref: 09/H1210/88). Approval pending as of 17/10/2009. |
| Health condition(s) or problem(s) studied | Stroke rehabilitation |
| Intervention | This is a pragmatic phase III cluster randomised controlled trial with independent assessment. Randomisation will be conducted by the Clinical Trials Unit (CTU) and only revealed to the treating occupational therapist. Occupational therapy is delivered to patients after stroke to improve self care independence, activity and reduce the risk of poor outcome. A package of occupational therapy intervention for a care home population has been developed using evidence and consensus and will be delivered by a qualified occupational therapist to both the individual resident and the care home staff. It will be targeted towards improving independence in personal activities of daily living such as; feeding, dressing, toileting, bathing, transferring and mobilising. The frequency and duration will be dependent on the resident and therapist's agreed goals and will be around 8 hours per resident over the three-month period. Occupational therapy will follow a routine process using a 'client centred approach' and will include a continuous process of assessment, treatment and reassessment. Affordable assistive technology and home adaptations (mean expenditure - from pilot £120) will be provided, consistent with current NHS and local authority social care. Staff will receive individual training and group education sessions on facilitating independence and mobility and the use of adaptive equipment, a description of which has been published. |
| Intervention type | Other |
| Primary outcome measure | Independence in activities of daily living, assessed using the Barthel Activity of Daily Living Index, a commonly used measure (toileting, dressing, feeding, continence, mobility and grooming) containing 10 items and scored from 0-20 (with 20 being more independent) All primary and secondary outcome measures will be assessed at baseline (0 months), after the intervention (3 months) and at follow-up (6 and 12 months). |
| Secondary outcome measures | 1. Rivermead Mobility Index (RMI), a 15 item measure of functional mobility (scored 0-15, 15 being more mobile) 2. Mood, assessed by a 15-item Geriatric Depression Scale (GDS15), and informant version 3. Adverse events 4. Staff attitude 5. Health utility will be estimated using the Euroqol EQ-5D All primary and secondary outcome measures will be assessed at baseline (0 months), after the intervention (3 months) and at follow-up (6 and 12 months). In addition, the Mini-Mental State Examination (MMSE) will be used at baseline to determine the level of a resident's cognitive impairment; not as an exclusion criterion. |
| Overall study start date | 01/01/2010 |
| Completion date | 28/02/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 840 |
| Key inclusion criteria | Adult men and women living in a care home with a history of stroke or transient ischaemic attack (TIA) |
| Key exclusion criteria | Active end of life care plan |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 28/02/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
B15 2TT
United Kingdom
Sponsor information
University/education
Research and Commercial Services
Birmingham
B15 2TT
England
United Kingdom
| b.w.laverty@bham.ac.uk | |
| Website | http://www.bham.ac.uk/ |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 09/07/2012 | Yes | No | |
| Results article | results | 05/02/2015 | Yes | No | |
| Results article | results | 01/02/2016 | Yes | No |
Editorial Notes
02/03/2016: Publication reference added.
On 12/11/2012 the overall trial end date was updated from 31/12/2014 to 28/02/2013.
