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| A randomised controlled study of patients seen in a special nurse-led clinic after gastroscopy investigation for symptoms related to indigestion |
| Source of record | UK Trials |
| ISRCTN | ISRCTN08109872 |
| Date ISRCTN assigned | 02/04/2008 |
| Local reference number(s) | RHM MED0719 |
| Public title | A randomised controlled study of patients seen in a special nurse-led clinic after gastroscopy investigation for symptoms related to indigestion |
| Scientific title | A randomised controlled trial of structured nurse-led clinic follow-up for dyspeptic patients after direct access gastroscopy |
| Acronym | N/A |
| Disease/condition/study domain | Gastroscopy |
| 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. |
| Design/methodology | Single-centre, randomised, placebo-controlled trial. |
| Research ethics review | Southampton & South West Hampshire Research Ethics Committees (B). Date of approval: 22nd March 2002 (REC reference: 050/02) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Male and female patients with dyspepsia 2. Over 18 years old 3. Undergoing direct access gastroscopy |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/02/2003 |
| Anticipated end date | 28/02/2005 |
| Status of trial | Completed |
| Target number of participants | 186 |
| Interventions | 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 |
| 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. |
| Secondary outcome measure(s) | Compares before and after intervention within same group in: 1. GLADYS 2. SF-12 3. UHD costs |
| Publications | Results in http://www.ncbi.nlm.nih.gov/pubmed/16531518 |
| Sources of funding | 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. |
| Sponsor name | Southampton University Hospitals NHS Trust (UK) |
| Sponsor details | Research and Development Department Trust Management Office Mailpoint 18 Treamona Road Southampton United Kingdom SO16 6YD |
| Sponsor website | http://www.suht.nhs.uk |
| Contact name | Dr Praful Patel |
| Contact details | Southampton University Hospital NHS Trust Department of Gastroenterology Level D West wing Southampton United Kingdom SO16 6YD |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN08109872 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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