Measuring treatment burden in stroke
Research type
Research Study
Full title
Developing a patient-reported measurement of treatment burden in stroke
IRAS ID
230946
Contact name
Katie Gallacher
Contact email
Sponsor organisation
Greater Glasgow and Clyde
Clinicaltrials.gov Identifier
TSA LECT 2017/01, Stroke Association
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Stroke survivors often report finding it difficult to follow treatments recommended by their doctors, nurses and therapists, for example they can feel overwhelmed by having to learn about treatments or visit the clinic. The design of health services can influence how difficult it is to follow treatments, for example a lack of information from doctors may cause unnecessary worry. Individuals differ in their abilities to manage their health problems, depending on factors such as how much money and family support they have. We define the workload of healthcare and the impact of this on wellbeing as treatment burden. In previous research we spoke to stroke survivors about their healthcare and searched the medical literature for ways of measuring treatment burden in stroke. We could not find suitable measures, so we need to develop one. This project aims to adapt a measure of treatment burden that has been developed for use in other populations so that it is suitable for use in stroke survivors. This measure will involve collecting information directly from stroke survivors known as a ‘patient-reported measure’. We will adapt the exisiting measure based on our previous research and then test it on a group of stroke survivors to find out how easy it is to understand and use. We will amend the measure until the group are happy with it. We will then test it in a large group of stroke survivors to see if it measures treatment burden truly and reliably using statistical methods. We aim to use this measure in future research to ascertain if stroke survivors with high burden have worse outcomes such as a further stroke. We also hope to develop new ways of providing healthcare and will be able to discover if these new ways are less burdensome by using our new measure.
Lay Summary of Results
Aims
- To develop a questionnaire that measures the burden of treatment experienced after stroke from the patient’s perspective.
- To test if the developed questionnaire is accurate, reliable and easy to use.Results
- Participants were slightly younger, more affluent and more able bodied that the average Scottish stroke survivor, but a good range of disabilities were reported including speech problems, arm weakness and difficulty walking.
- PETS-stroke is a valid and reliable measure. It measures treatment burden consistently and patients found it easy to use.
- Treatment burden, measured by PETS-stroke, was significantly associated with higher stroke illness, lower readiness to self-manage and lower satisfaction with care. This helps to reassure us that PETS-stroke measures treatment burden accurately, as these results are what we would expect to find.
- Higher treatment burden was significantly associated with lower sociodemographic status (less affluence) in 8 out of 10 treatment burden categories.Key findings
- The questionnaire developed and tested in this study is called the PETS-Stroke (Patient Experience of Treatments and Self-Management - Stroke).
- PETS-stroke has 34 questions or items that each ask about a different aspect of treatment burden.
- Our results suggest that PETS-stroke measures treatment burden accurately, reliably and consistently over time.
- The PETS-stroke is easy to use for stroke survivors.
- PETS-stroke will allow researchers to measure the treatment burdens associated with stroke treatments, for example those being tested in clinical trials. This is important because treatments that are burdensome may negatively impact quality of life after stroke.Potential impact
- Treatment burden is defined as the workload of healthcare and the impact on wellbeing. It has previously been under recognised by clinicians, researchers and policy makers.
- Treatment burden is important because it can negatively impact peoples’ lives after stroke.
- PETS-stroke can be used in clinical trials of stroke treatments to examine the impact that new treatments or therapies have on people.
- Knowledge of any potential treatment burdens will allow a more informed discussion between healthcare professionals and patients and can also inform policy decisions.Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: N/A
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Pending
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected: 30/06/2025
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Pending
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected: 30/06/2025
If no, explain why they haven't:
Have you enabled sharing of study data with others?: Yes
If yes, describe or provide URLs to how it has been shared: We have ethical approval to ask participants for consent to store fully anonymised data for use in future research projects. We have ethical approval to grant another party access to the data for research, but not for storing in a public data repository.
If no, explain why sharing hasn't been enabled:
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: N/A
Submitted on: 15/08/2024REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/LO/0871
Date of REC Opinion
23 Jun 2020
REC opinion
Favourable Opinion