Self assessment of Health And Illness: Research In Neath Gastroenterology unit
ISRCTN | ISRCTN08768987 |
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DOI | https://doi.org/10.1186/ISRCTN08768987 |
Secondary identifying numbers | 05/1/110 |
- Submission date
- 04/09/2007
- Registration date
- 14/02/2008
- Last edited
- 03/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Faiz Ali
Scientific
Scientific
Department of Gastroenterology
Neath Port Talbot Hospital
Baglan Way
Port Talbot
SA12 7BX
United Kingdom
Study information
Study design | Single-centre pragmatic randomised controlled trial with repeated measurements |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Diagnostic |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Self assessment of Health And Illness: Research In Neath Gastroenterology unit |
Study acronym | SHAIRING |
Study objectives | The need to involve patients more actively in decisions about their care is recognised in the NHS Plans for England and Wales. Central to this is the ability to measure a patient's progress from their own perspective. This research will give insight into the feasibility and practicality of measuring and using patient-focused outcomes routinely in outpatients. In the context of a major, multi-centre trial, MINuET (registered with ISRCTN82765705 - http://www.controlled-trials.com/ISRCTN82765705), a simple quality of life measure for use by patients with gastrointestinal disorders, the Gastrointestinal Symptom Rating Questionnaire (GSRQ) has been developed. This is a system-specific questionnaire. It is quick and simple to complete and is applicable to the majority of patients with GI disorders. We hope it will enable the integration of patient-focused measurement into routine clinical practice. There are three main research questions: 1. In a busy gastroenterology clinic is it feasible for patients routinely to complete electronic questionnaires about their Health-Related Quality of Life (HRQL) - both generic and GastroIntestinal (GI)-specific - and for doctors to use this information? This will be assessed by qualitative interviews of staff and a sub-sample of patients, the proportions of clinic attendees who were eligible and willing to complete electronic questionnaires, and the proportion who successfully completed them among the two groups allocated to do so. 2. Does this intervention improve process of care, notably doctor-patient communication and management decisions? This will be assessed by qualitative interviews, and clinic waiting and consultation times. Limited information on diagnosis and symptoms will be obtained from routine medical records. 3. Does this intervention improve patient outcomes? This will be assessed by a) patient-completed postal questionnaires at baseline, 1 month and 3 months and b) anonymous patient satisfaction questionnaires. |
Ethics approval(s) | South West Wales Local Research Ethics Committee, 24/03/2006, ref: 06/WMV02/4 |
Health condition(s) or problem(s) studied | Gastrointestinal disorders |
Intervention | Electronic Health Related Quality of Life Questionnaire (GSRQ/EQ-VAS) - a combination of Gastrointestinal Symptom Rating Questionnaire and EQ-visual analogue scale. The intervention was carried out whenever patients attended clinic visits during the 3-month study follow-up period rather than at planned timepoints. |
Intervention type | Other |
Primary outcome measure | The Physical and Mental Component Scores from the 36-item Short Form health survey (SF-36), measured at 3 months. |
Secondary outcome measures | 1. SF-36 scores at 1 month 2. EuroQol (EQ-5D) quality of life questionnaire, filled at recruitment (baseline), 1 month and 3 months 3. Clinic waiting times 4. Length of consultation, taken from routine patient records 5. Patient satisfaction, measured by the Outpatient Medical Interview Satisfaction Scale (OMISS) after each visit to the clinic |
Overall study start date | 29/07/2006 |
Completion date | 30/09/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Both |
Target number of participants | 500 |
Total final enrolment | 302 |
Key inclusion criteria | All patients attending gastroenterology clinic who are fluent in English and likely to be followed up in the clinic within 3 months. |
Key exclusion criteria | 1. Problem is primarily non-gastrointestinal 2. Currently taking part in an HRQL study 3. Frail or seriously compromised (American Society of Anaesthesiologists [ASA] status 4+) |
Date of first enrolment | 29/07/2006 |
Date of final enrolment | 30/09/2007 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Department of Gastroenterology
Port Talbot
SA12 7BX
United Kingdom
SA12 7BX
United Kingdom
Sponsor information
Wales Office of Research and Development for Health and Social Care (UK)
Government
Government
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ
United Kingdom
https://ror.org/03w4jzj90 |
Funders
Funder type
Government
Wales Office of Research and Development for Health and Social Care - Funding Scheme 2005 (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 2009 results in: https://doi.org/10.3329/bmrcb.v35i2.2123 (added 03/01/2020) |
IPD sharing plan |
Editorial Notes
03/01/2020: The following changes have been made:
1. Publication reference added to the publication and dissemination plan.
2. The total final enrolment number has been added from the reference.
16/03/2017: No publications found in PubMed, verifying study status with principal investigator.