Self assessment of Health And Illness: Research In Neath Gastroenterology unit

ISRCTN	ISRCTN08768987
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

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
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
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

Sponsor information

Wales Office of Research and Development for Health and Social Care (UK)
Government

Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ
United Kingdom

"ROR"	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
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.