Hemianopia Activity-Based InTervention (HABIT): refining and operationalising a rehabilitation intervention for visual field loss after stroke
| ISRCTN | ISRCTN54718796 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54718796 |
| IRAS number | 270718 |
| Secondary identifying numbers | IRAS 270718, CPMS 45000 |
- Submission date
- 09/09/2020
- Registration date
- 06/10/2020
- Last edited
- 28/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Visual field loss, the inability to see to one side (hemianopia), affects around a third of people with stroke; in the UK that’s more than 30,000 people each year, and 5 million worldwide. Clinicians, patients and carers say treating visual problems after stroke is a top research priority. People with hemianopia have the impression of a complete visual world, yet often have severe difficulties because of their visual loss. Many people cannot find things or read easily, lose balance or bump into things and sometimes fall when walking, become overwhelmed by crowded spaces and cannot drive. This reduces confidence, independence and quality of life and increases loneliness. There is no standard treatment for stroke-related visual field loss; no treatment has enough evidence to be recommended for use across the NHS. Occupational therapists are the main people who treat visual field loss, but lack of knowledge about how to treat people limits what can be done. Best research evidence supports training people to compensate for visual field loss by “scanning” (looking repeatedly across into the affected area of vision), teaching them to search for and pay attention to the affected side of vision, and re-training them in reading. The researchers will work with people with visual loss after stroke, their carers and therapists to design a manual showing how to use the treatment, and videos for training and educating health professionals, patients and carers. They will then try out the training, manual and videos in several different NHS centres, and improve them based on feedback from therapists, stroke survivors and carers. People with hemianopia will be involved throughout the study. The aim of this study is to produce a treatment for loss of vision after stroke in adults that can be used in NHS services from early hospital-based rehabilitation to rehabilitation and care at home.
Who can participate?
1. NHS staff involved in providing therapy for visual rehabilitation after stroke at a participating centre.
2. Patients with visual field loss after stroke, recruited from a participating centre
What does the study involve?
The researchers will provide training for therapy staff on how to use the intervention with patients. They will collect feedback on this training session so it can be refined and improved as the study goes along. Once trained, Therapy Practitioners will use the intervention with patients recruited to the study. Both patients and therapists will provide feedback on the intervention to the study team. Feedback will be used to refine and implement these recommendations to work towards operationalising the intervention.
What are the possible benefits and risks of participating?
For patients who take part in the study, there are no serious side effects of this intervention on top of usual NHS care. However, some patients may find using the intervention tiring or that the intervention does not help them. For therapy practitioners, there is little anticipation of any significant risks to taking part, though it may take some time to use the tool.
Where is the study run from?
North Bristol NHS Trust, Southmead Hospital (UK)
When is the study starting and how long is it expected to run for?
October 2019 to November 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Philip Clatworthy
Philip.Clatworthy@nbt.nhs.uk
Contact information
Scientific
North Bristol NHS Trust
Southmead Hospital
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
| Phone | +44 (0)1174149330 |
|---|---|
| habitresearchstudy@nbt.nhs.uk |
Study information
| Study design | Refinement of an intervention, non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Hemianopia Activity-Based InTervention (HABIT): refining and operationalising a rehabilitation intervention for visual field loss after stroke |
| Study acronym | HABIT |
| Study objectives | To refine and operationalise a method of activity-based rehabilitation for people with visual field loss after stroke that can be delivered across the NHS. The resulting intervention will be called HABIT: the Hemianopia Activity-Based InTervention. |
| Ethics approval(s) | Approved 07/04/2020, Wales Research Ethics Committee 4 Wrexham (Health and Care Research Wales Support Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)7976 982591; Wales.REC4@wales.nhs.uk), REC ref: 20/WA/0093 |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | Occupational therapy visual rehabilitation intervention (hemianopia activity-based intervention). The main outcome from this study is the HABIT intervention itself which will comprise an online training, education and intervention tool with accompanying manual and description for replicating the intervention in future clinical studies. The researchers will provide training for therapy staff on how to use the intervention with patients. They will collect feedback on this training session so it can be refined and improved as the study goes along. Once trained, Therapy Practitioners will use the intervention with patients recruited to the study. Both patients and therapists will provide feedback on the intervention to the study team. Feedback will be used to refine and implement these recommendations to work towards operationalising the intervention. The total duration of intervention and follow up is 12 months (plus a further 3 months for analysis and dissemination). |
| Intervention type | Other |
| Primary outcome measure | The main outcome from this study is the HABIT intervention itself which will comprise an online training, education and intervention tool with accompanying manual and description for replicating the intervention in future clinical studies. |
| Secondary outcome measures | Secondary outcomes relating to future implementation and delivery in a clinical trial are detailed below: 1. Measuring recruitment and retention rates for a future clinical trial 2. Evaluating the feasibility of using the Canadian Occupational Performance Measure (COPM) as an outcome measure in a future evaluation 3. Evaluating the range of clients with whom HABIT can usefully be employed 4. Acceptability for patients, carers, therapists, therapy assistants and support workers |
| Overall study start date | 14/10/2019 |
| Completion date | 12/11/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 34 |
| Key inclusion criteria | 1. New stroke being managed on a stroke rehabilitation pathway 2. Presence of visual field defect on screening such as confrontation visual field testing e.g. as part of the NIHSS 3. Confirmation of visual field defect using perimetry 4. Visual field defect considered by a HABIT study trained OT to be causing difficulty with meaningful goals for rehabilitation 5. Willing and have capacity to provide informed consent to participate in the study |
| Key exclusion criteria | 1. Visual neglect severe enough to prevent any orientation beyond the midline to the affected side assessed by a treating clinician 2. Living outside of an area covered by the early supported discharge services or community providers associated with the recruiting centre if they are being discharged from inpatient services with ongoing therapy |
| Date of first enrolment | 12/10/2020 |
| Date of final enrolment | 12/08/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
Sponsor information
Hospital/treatment centre
Research & Innovation
Level 3, Learning & Research building
Southmead Hospital
Westbury on Trym
Bristol
BS10 5NB
England
United Kingdom
| Phone | +44 (0)1174149330 |
|---|---|
| researchsponsor@nbt.nhs.uk | |
| Website | https://www.nbt.nhs.uk/research-innovation |
"ROR" |
https://ror.org/036x6gt55 |
Funders
Funder type
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 | 01/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in high impact peer-reviewed journal. Protocol available on request. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon reasonable request from Dr Philip Clatworthy (Philip.Clatworthy@nbt.nhs.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
28/01/2021: Contact details updated.
01/12/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 14/07/2021 to 12/08/2021.
2. The overall trial end date was changed from 14/01/2022 to 12/11/2021.
05/10/2020: Trial's existence confirmed by the NIHR.
