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 designSingle-centre pragmatic randomised controlled trial with repeated measurements
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleSelf assessment of Health And Illness: Research In Neath Gastroenterology unit
Study acronymSHAIRING
Study objectivesThe 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) studiedGastrointestinal disorders
InterventionElectronic 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 typeOther
Primary outcome measureThe Physical and Mental Component Scores from the 36-item Short Form health survey (SF-36), measured at 3 months.
Secondary outcome measures1. 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 date29/07/2006
Completion date30/09/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants500
Total final enrolment302
Key inclusion criteriaAll patients attending gastroenterology clinic who are fluent in English and likely to be followed up in the clinic within 3 months.
Key exclusion criteria1. 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 enrolment29/07/2006
Date of final enrolment30/09/2007

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination plan2009 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.