Condition category
Circulatory System
Date applied
09/09/2020
Date assigned
06/10/2020
Last edited
06/10/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 January 2022

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Hannah Sheridan
habitresearchstudy@nbt.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Philip Clatworthy

ORCID ID

Contact details

North Bristol NHS Trust
Southmead Hospital
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
+44 (0)1174149330
habitresearchstudy@nbt.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 270718, CPMS 45000

Study information

Scientific title

Hemianopia Activity-Based InTervention (HABIT): refining and operationalising a rehabilitation intervention for visual field loss after stroke

Acronym

HABIT

Study hypothesis

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

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

Study design

Refinement of an intervention, non-randomized study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

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

Phase

Drug names

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 trial start date

14/10/2019

Overall trial end date

14/01/2022

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

34

Participant 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

Recruitment start date

12/10/2020

Recruitment end date

14/07/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North Bristol NHS Trust
Southmead Hospital Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust

Sponsor details

Research & Innovation
Level 3
Learning & Research building
Southmead Hospital
Westbury on Trym
Bristol
BS10 5NB
United Kingdom
+44 (0)1174149330
researchsponsor@nbt.nhs.uk

Sponsor type

Hospital/treatment centre

Website

https://www.nbt.nhs.uk/research-innovation

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in high impact peer-reviewed journal. Protocol available on request.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon reasonable request from Hannah Sheridan, Study Manager (hannah.sheridan@nbt.nhs.uk).

Intention to publish date

01/12/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/10/2020: Trial's existence confirmed by the NIHR.