A randomised controlled study of patients seen in a special nurse-led clinic after gastroscopy investigation for symptoms related to indigestion

ISRCTN ISRCTN08109872
DOI https://doi.org/10.1186/ISRCTN08109872
Protocol serial number RHM MED0719
Sponsor Southampton University Hospitals NHS Trust (UK)
Funder 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.
Submission date
27/02/2008
Registration date
02/04/2008
Last edited
02/04/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Praful Patel
Scientific

Southampton University Hospital NHS Trust
Department of Gastroenterology
Level D
West wing
Southampton
SO16 6YD
United Kingdom

Study information

Primary study designInterventional
Study designSingle-centre, randomised, placebo-controlled trial.
Secondary study designRandomised controlled trial
Scientific titleA randomised controlled trial of structured nurse-led clinic follow-up for dyspeptic patients after direct access gastroscopy
Study objectivesThe 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(s)Southampton & South West Hampshire Research Ethics Committees (B). Date of approval: 22nd March 2002 (REC reference: 050/02)
Health condition(s) or problem(s) studiedGastroscopy
InterventionThis 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 typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

Compares before and after intervention within same group in:
1. GLADYS
2. SF-12
3. UHD costs

Completion date28/02/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration186
Key inclusion criteria1. Male and female patients with dyspepsia
2. Over 18 years old
3. Undergoing direct access gastroscopy
Key exclusion criteriaThere 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
Date of first enrolment01/02/2003
Date of final enrolment28/02/2005

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Southampton University Hospital NHS Trust
Southampton
SO16 6YD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/04/2006 Yes No
BMC - Part of Springer Nature Springer Nature