Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RHM MED0719
Study information
Scientific title
A randomised controlled trial of structured nurse-led clinic follow-up for dyspeptic patients after direct access gastroscopy
Acronym
Study hypothesis
The aim is to study patients with a confirmed endoscopic diagnosis of the following:
1. Mild gastro oesophageal reflux disease (non-erosive and mild oesophagitis)
2. Hiatus hernia (any size)
3. Non-ulcer dyspepsia (normal findings, mild or moderate gastritis and duodenitis)
Study hypothesis:
An experienced gastrointestinal nurse practitioner providing structured patient-centred advice at follow-up clinic after gastroscopy to patients with mild dyspepsia, would reduce drug costs without adversely affecting symptoms relief or quality of life.
Ethics approval
Southampton & South West Hampshire Research Ethics Committees (B). Date of approval: 22nd March 2002 (REC reference: 050/02)
Study design
Single-centre, randomised, placebo-controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Gastroscopy
Intervention
This is a randomised placebo-controlled trial with concealed allocation (random number table) of study cohorts. Post-intervention assessor is blinded to diagnosis and study status.
Baseline data collection:
1. Demography
2. Body mass index (BMI)
3. Social habit status
4. Ulcer healing drugs (UHD; Histamine 2 antagonist, proton pump inhibitor) used in the 6 months before investigation
5. Glasgow dyspepsia severity score (GLADYS)
6. Health related general well being (12-item short form health survey [SF-12])
After gastroscopy, eligible patients are randomised to either normal (control) practice (return to GP for follow-up treatment) or intervention (to nurse follow-up).
The nurse-led clinic last for 35 minutes and a full medical history is taken. The clinical management is based on national and local guidelines, with reference to findings as well as patients' predominant symptoms. Counselling and lifestyle advice, including bespoke information leaflets given and treatment concordance agreed; further investigation may be initiated if required. For consistency and reproducibility 'History taking' and 'Lifestyle advice' proformas are devised for use. Clinic letter with information on intervention and treatment recommendations is sent to patients' GP after consultation.
Six months after gastroscopy all patients are contacted by telephone for reassessment of the following:
1. Weight
2. GLADYS
3. SF-12
4. UHD used in the six months after gastroscopy
5. Usefulness of post-investigation follow-up
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The difference between the nurse group and GP group after intervention in:
1. GLADYS: 8 questions and a total low score equals to least symptoms with a minimum of 0 and maximum 20
2. SF-12: Six questions (3 have 2 parts and 1 has 4 parts). A total high score in this measurement denotes better health related general well being with a minimum 0 and maximum 900
3. UHD costs 6 months before and after gastroscopy. The UHD cost analysis is based on the price listed in the Drug Tariff (generic items) or MIMS (branded items). They are summed according to class and averaged.
Secondary outcome measures
Compares before and after intervention within same group in:
1. GLADYS
2. SF-12
3. UHD costs
Overall trial start date
01/02/2003
Overall trial end date
28/02/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male and female patients with dyspepsia
2. Over 18 years old
3. Undergoing direct access gastroscopy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
186
Participant exclusion criteria
There are 2 stages of filtering for exclusion as follows:
1. Before gastroscopy - From referral letters/forms patients with sinister symptoms:
1.1. Anaemia
1.2. Weight loss over half a stone in three months
1.3. Haematemesis
1.4. Dysphagia
1.5. Vomiting
2. After gastroscopy:
2.1. Peptic ulcer
2.2. Tumour
2.3. Severe oesophagitis
2.4. Barrett's oesophagus
2.5. Anatomical abnormality and
2.6. Post-operative stomach
Recruitment start date
01/02/2003
Recruitment end date
28/02/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southampton University Hospital NHS Trust
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Southampton University Hospitals NHS Trust (UK)
Sponsor details
Research and Development Department
Trust Management Office
Mailpoint 18
Treamona Road
Southampton
SO16 6YD
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Other
Funder name
This study was investigator-funded with the agreement of the Southampton University Hospital NHS Trust that secretarial and out-patient work force can be utilised as long as it is planned into routine work.
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/16531518
Publication citations
-
Results
British Society of Gastroenterology Annual Meeting, 20-23 March 2006, Birmingham, England, United Kingdom. Abstracts., Gut, 2006, 55 Suppl 2, A1-119.