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Assessment of Patient Reported Health Status Questions Via Four Different Methods of Administration, in Stroke Survivors.

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ClinicalTrials.gov Identifier: NCT03177161
Recruitment Status : Completed
First Posted : June 6, 2017
Last Update Posted : July 25, 2018
Sponsor:
Collaborator:
Stroke Implementation Group (Wales)
Information provided by (Responsible Party):
Dr Jonathan Hewitt, Aneurin Bevan University Health Board

Brief 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). 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.


Condition or disease Intervention/treatment Phase
Stroke Cerebral Infarction Cerebral Hemorrhage Stroke Hemorrhagic Stroke, Ischemic Stroke of Uncertain Pathology Other: 15 Patient Reported Health Status Questions Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 472 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Participants will not be made aware of the other modes of delivery available and will be assigned a single method of delivery prior to consent.
Primary Purpose: Health Services Research
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.
Actual Study Start Date : August 12, 2017
Actual Primary Completion Date : January 15, 2018
Actual Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Postal Questionnaire Other: 15 Patient Reported Health Status Questions
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.

Experimental: Online Questionnaire Other: 15 Patient Reported Health Status Questions
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.

Experimental: Face-to-face Questionnaire Other: 15 Patient Reported Health Status Questions
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.

Experimental: Telephone Questionnaire Other: 15 Patient Reported Health Status Questions
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Diagnosis of a Transient Ischaemic Attack (ICD G45)
  • Diagnosis of a Subarachnoid Haemorrhage (ICD I60)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177161


Locations
United Kingdom
Ysbyty Ystrad Fawr
Ystrad Mynach, Caerphilly, United Kingdom, CF82 7EP
Royal Gwent Hospital
Newport, Gwent, United Kingdom, NP20 2UB
Nevill Hall Hospital
Abergavenny, Monmouthshire, United Kingdom, NP7 7EG
Prince Charles Hospital
Merthyr Tydfil, United Kingdom, CF47 9DT
Sponsors and Collaborators
Dr Jonathan Hewitt
Stroke Implementation Group (Wales)
Investigators
Study Director: Jonathan Hewitt, MBBS, FRCP (Glas), MSc, PhD Cardiff University & Aneurin Bevan University Health Board

Publications:
Responsible Party: Dr Jonathan Hewitt, Clinical Senior Lecturer (Cardiff University) & Honorary Consultant Physician (ABUHB), Aneurin Bevan University Health Board
ClinicalTrials.gov Identifier: NCT03177161     History of Changes
Other Study ID Numbers: IRAS 222226
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Jonathan Hewitt, Aneurin Bevan University Health Board:
PROM
Patient Reported Outcome Measure
PROMIS
PROMIS-10
PROMIS Global Health
RiksStroke
ICHOM
International Consortium for Health Outcomes Measurement
Wales
Administration
Method
Delivery

Additional relevant MeSH terms:
Stroke
Infarction
Hemorrhage
Cerebral Infarction
Cerebral Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Intracranial Hemorrhages