StrokeNCT03177161
Assessment of Patient Reported Health Status Questions Via Four Different Methods of Administration, in Stroke Survivors.
A study testing 15 Patient Reported Health Status Questions in people with Stroke and Cerebral Infarction, run by Dr Jonathan Hewitt at 4 sites in United Kingdom.
Trial summary
A Patient Reported Outcome Measure (PROM) is a questionnaire that asks patients for their views on their own health or the impact of healthcare they have received on their health and quality of life (RCN, 2011). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebral Infarction, Cerebral Hemorrhage
- What is being tested?
- 15 Patient Reported Health Status Questions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 12 Aug 2017to 1 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically confirmed diagnosis of stroke either Cerebral Infarct (ICD I63), Cerebrovascular Haemorrhage (ICD161) or Stroke, not specified as haemorrhage or infarction (ICD I64).
- Patients over 18 years old (≥ 18 years old)
- Had a diagnosis of stroke within the last 4-8 months (Stroke diagnosis ≥ 4months to ≤ 8 months)
Who cannot join
- Diagnosis of a Transient Ischaemic Attack (ICD G45)
- Diagnosis of a Subarachnoid Haemorrhage (ICD I60)
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Nevill Hall Hospital
Abergavenny, Monmouthshire, NP7 7EG
Prince Charles Hospital
Merthyr Tydfil, CF47 9DT
Royal Gwent Hospital
Newport, Gwent, NP20 2UB
Ysbyty Ystrad Fawr
Ystrad Mynach, Caerphilly, CF82 7EP
About this study
Official title: Assessment of Patient Reported Health Status Questions Via Four Different Methods of Administration, in Stroke Survivors. A Randomised Controlled Trial. A Non-inferiority Study of the Response Rate for Four Alternative Methods of Administration of 15 Patient Reported Health Status Questions in Stroke Survivors.
A Patient Reported Outcome Measure (PROM) is a questionnaire that asks patients for their views on their own health or the impact of healthcare they have received on their health and quality of life (RCN, 2011). The benefit of PROMS is that they gather information from the patient's perspective, which offers great potential to improve the quality and outcomes of health services (Department of Health 2011).
There is a PROM (the PROMIS-10 Global Health) and a number of extra questions that are recommended for use in people who have had a stroke by the International Consortium for Health Outcomes Measurement, but the best way of delivering these questions for stroke survivors is unknown.
Read more
At present, the NHS in England, Scotland and Wales are required to offer every stroke survivors a 6 month post stroke follow-up appointment. Currently, the information collected at the 6 month review is not from the patient's perspective and the best method of collecting this information has not been established. The Sentinel Stroke National Audit Programme (SSNAP) which is led by the Royal College of Physicians in London promote the 6 month follow-up assessment. SSNAP recognise that currently 4 different methods of 6 month follow-up appointment occur. The current methods in use are face-to-face assessment, telephone interview, online questionnaire or postal questionnaire.
The aim of this research is to understand if there is a difference between these 4 methods of delivering these questions in people who have had a stroke.
As part of the 6 month review this research study will assess the response rate for 15 Patient Reported Health Status questions across the 4 recognised methods of delivery;
- Face-to-Face
- Telephone
- Online
- Post
To conduct this research study a sample of 808 stroke survivors will be asked to take part in the research. From these 808 people, 202 participants will be randomly assigned to each method of administration (Face-to-Face Interview, Telephone Interview, Postal Questionnaire and Online Questionnaire).
The questionnaires received by the research team will not record any personally identifiable information. The data will then be utilised by the researchers for statistical analysis in order to identify, which method of the 4 methods of administration, under investigation, is the most acceptable for stroke survivors. The conclusions of this research will inform the roll-out of the most appropriate method of delivering the 6 month stroke follow-up review for stroke survivors.
- Conditions
- Stroke, Cerebral Infarction, Cerebral Hemorrhage, Stroke Hemorrhagic, Stroke, Ischemic, Stroke of Uncertain Pathology
- Being tested
- 15 Patient Reported Health Status Questions
- Keywords
- PROM, Patient Reported Outcome Measure, PROMIS, PROMIS-10, PROMIS Global Health, RiksStroke, ICHOM, International Consortium for Health Outcomes Measurement, Wales, Administration, Method, Delivery
- Medical subject headings
- Stroke, Cerebral Infarction, Cerebral Hemorrhage, Hemorrhagic Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 Patient Reported Health Status QuestionsOther
The PROMIS-10 Global Health, three single item questions (ambulation, toileting, and dressing) that have been borrowed from the RiksStroke (The National Quality Register for Stroke - Sweden) and two further questions on feeding and communication have been included from the ICHOM Standard Set for Stroke.
| Study group | Role | What they receive |
|---|---|---|
| Postal Questionnaire | Experimental | Not described Receives: Other: 15 Patient Reported Health Status Questions |
| Online Questionnaire | Experimental | Not described Receives: Other: 15 Patient Reported Health Status Questions |
| Face-to-face Questionnaire | Experimental | Not described Receives: Other: 15 Patient Reported Health Status Questions |
| Telephone Questionnaire | Experimental | Not described Receives: Other: 15 Patient Reported Health Status Questions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total response rate for all 4 methods of delivery
As defined by response rate. This will be measured by the number of individuals that return the questionnaire for each of the four allocation groups.
Measured: 120 to 240 days post index event
Secondary outcomes (3)
Total response rate across the four different methods of administration for 15 Patient Reported Health Status questions with people with communication issues (e.g. aphasia)
Measured: 120 to 240 days post index event
Total response rate across the four different methods of administration for 15 Patient Reported Health Status questions by stroke severity (as defined by NIHSS on admission)
Measured: 120 to 240 days post index event
Total response rate across the four different methods of administration for 15 Patient Reported Health Status questions by stroke type (as defined by ICD classification)
Measured: 120 to 240 days post index event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start12 Aug 2017
- Primary completion15 Jan 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Jonathan Hewitt
- Sponsor type
- University, hospital or other
- Collaborators
- Stroke Implementation Group (Wales)
- Responsible party
- Sponsor-investigator, Dr Jonathan Hewitt, Aneurin Bevan University Health Board
- Investigators
- Jonathan Hewitt, MBBS, FRCP (Glas), MSc, PhD, Study director, Cardiff University & Aneurin Bevan University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177161
- Sponsor's protocol ID
- IRAS 222226
- Status last verified
- Jul 2018
- First submitted
- 26 May 2017
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith A, Pennington A, Carter B, Gething S, Price M, White J, Dewar R, Hewitt J. Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol. Trials. 2018 Jul 3;19(1):349. doi: 10.1186/s13063-018-2694-4.
PubMed 29970156Hewitt J, Pennington A, Smith A, Gething S, Price M, White J, Dewar R, Carter B. A multi-centre, UK-based, non-inferiority randomised controlled trial of 4 follow-up assessment methods in stroke survivors. BMC Med. 2019 Jul 2;17(1):111. doi: 10.1186/s12916-019-1350-5.
PubMed 31262317
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient Reported Health Status Questions Via Four Different Methods of Administration, in Stroke Survivors. A Randomised Controlled Trial. A Non-inferiority Study of the Response Rate for Four Alternative Methods of Administration of 15 Patient Reported Health Status Questions in Stroke Survivors.
- ClinicalTrials.gov ID
- NCT03177161
- Acronym / sponsor ID
- IRAS 222226
- Conditions
- Stroke, Cerebral Infarction, Cerebral Hemorrhage, Stroke Hemorrhagic, Stroke, Ischemic, Stroke of Uncertain Pathology
- Keywords
- PROM, Patient Reported Outcome Measure, PROMIS, PROMIS-10, PROMIS Global Health, RiksStroke, ICHOM, International Consortium for Health Outcomes Measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Dr Jonathan HewittUniversity, hospital or other
- Collaborators
- Stroke Implementation Group (Wales)
- Study start
- 12 Aug 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Patient Reported Outcome Measure (PROM) is a questionnaire that asks patients for their views on their own health or the impact of healthcare they have received on their health and quality of life (RCN, 2011). The benefit of PROMS is that they gather information from the patient's perspective, which offers great potential to improve the quality and outcomes of health services (Department of Health 2011).
There is a PROM (the PROMIS-10 Global Health) and a number of extra questions that are recommended for use in people who have had a stroke by the International Consortium for Health Outcomes Measurement, but the best way of delivering these questions for stroke survivors is unknown.
At present, the NHS in England, Scotland and Wales are required to offer every stroke survivors a 6 month post stroke follow-up appointment. Currently, the information collected at the 6 month review is not from the patient's perspective and the best method of collecting this information has not been established. The Sentinel Stroke National Audit Programme (SSNAP) which is led by the Royal College of Physicians in London promote the 6 month follow-up assessment. SSNAP recognise that currently 4 different methods of 6 month follow-up appointment occur. The current methods in use are face-to-face assessment, telephone interview, online questionnaire or postal questionnaire.
The aim of this research is to understand if there is a difference between these 4 methods of delivering these questions in people who have had a stroke.
As part of the 6 month review this research study will assess the response rate for 15 Patient Reported Health Status questions across the 4 recognised methods of delivery;
- Face-to-Face
- Telephone
- Online
- Post
To conduct this research study a sample of 808 stroke survivors will be asked to take part in the research. From these 808 people, 202 participants will be randomly assigned to each method of administration (Face-to-Face Interview, Telephone Interview, Postal Questionnaire and Online Questionnaire).
The questionnaires received by the research team will not record any personally identifiable information. The data will then be utilised by the researchers for statistical analysis in order to identify, which method of the 4 methods of administration, under investigation, is the most acceptable for stroke survivors. The conclusions of this research will inform the roll-out of the most appropriate method of delivering the 6 month stroke follow-up review for stroke survivors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Postal Questionnaire | Experimental | Other: 15 Patient Reported Health Status Questions |
| Online Questionnaire | Experimental | Other: 15 Patient Reported Health Status Questions |
| Face-to-face Questionnaire | Experimental | Other: 15 Patient Reported Health Status Questions |
| Telephone Questionnaire | Experimental | Other: 15 Patient Reported Health Status Questions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically confirmed diagnosis of stroke either Cerebral Infarct (ICD I63), Cerebrovascular Haemorrhage (ICD161) or Stroke, not specified as haemorrhage or infarction (ICD I64).
- Patients over 18 years old (≥ 18 years old)
- Had a diagnosis of stroke within the last 4-8 months (Stroke diagnosis ≥ 4months to ≤ 8 months)
Key exclusion criteria (2 listed)
- Diagnosis of a Transient Ischaemic Attack (ICD G45)
- Diagnosis of a Subarachnoid Haemorrhage (ICD I60)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 15 Patient Reported Health Status QuestionsThe PROMIS-10 Global Health, three single item questions (ambulation, toileting, and dressing) that have been borrowed from the RiksStroke (The National Quality Register for Stroke - Sweden) and two further questions on feeding and communication have been included from the ICHOM Standard Set for Stroke. | Other | Face-to-face Questionnaire, Online Questionnaire, Postal Questionnaire, Telephone Questionnaire |
Primary outcome
Total response rate for all 4 methods of delivery
Time frame: 120 to 240 days post index event
As defined by response rate. This will be measured by the number of individuals that return the questionnaire for each of the four allocation groups.
3 secondary outcomes
Total response rate across the four different methods of administration for 15 Patient Reported Health Status questions with people with communication issues (e.g. aphasia)
Time frame: 120 to 240 days post index event
Total response rate across the four different methods of administration for 15 Patient Reported Health Status questions by stroke severity (as defined by NIHSS on admission)
Time frame: 120 to 240 days post index event
Total response rate across the four different methods of administration for 15 Patient Reported Health Status questions by stroke type (as defined by ICD classification)
Time frame: 120 to 240 days post index event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Background: PubMed 29970156Smith A, Pennington A, Carter B, Gething S, Price M, White J, Dewar R, Hewitt J. Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol. Trials. 2018 Jul 3;19(1):349. doi: 10.1186/s13063-018-2694-4.
- Derived from this study: PubMed 31262317Hewitt J, Pennington A, Smith A, Gething S, Price M, White J, Dewar R, Carter B. A multi-centre, UK-based, non-inferiority randomised controlled trial of 4 follow-up assessment methods in stroke survivors. BMC Med. 2019 Jul 2;17(1):111. doi: 10.1186/s12916-019-1350-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Hewitt, MBBS, FRCP (Glas), MSc, PhD study director
Cardiff University & Aneurin Bevan University Health Board
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15 Patient Reported Health Status Questions in people with Stroke and Cerebral Infarction, run by Dr Jonathan Hewitt at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total response rate for all 4 methods of delivery (time frame: 120 to 240 days post index event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03177161, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.