Condition category
Digestive System
Date applied
04/09/2007
Date assigned
14/02/2008
Last edited
28/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Faiz Ali

ORCID ID

Contact details

Department of Gastroenterology
Neath Port Talbot Hospital
Baglan Way
Port Talbot
SA12 7BX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

05/1/110

Study information

Scientific title

Acronym

SHAIRING

Study hypothesis

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

South West Wales Local Research Ethics Committee, 24/03/2006, ref: 06/WMV02/4

Study design

Single-centre pragmatic randomised controlled trial with repeated measurements

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

29/07/2006

Overall trial end date

30/09/2007

Reason abandoned

Eligibility

Participant inclusion criteria

All patients attending gastroenterology clinic who are fluent in English and likely to be followed up in the clinic within 3 months.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

500

Participant 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+)

Recruitment start date

29/07/2006

Recruitment end date

30/09/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Gastroenterology
Port Talbot
SA12 7BX
United Kingdom

Sponsor information

Organisation

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

Sponsor details

Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Wales Office of Research and Development for Health and Social Care - Funding Scheme 2005 (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes