| Source of record | UK Trials |
| ISRCTN | ISRCTN72253427 |
| Date ISRCTN assigned | 19/02/2003 |
| Local reference number(s) | G106/1048 |
| Public title | Assisting decision making in menorrhagia in primary care: a randomised controlled trial to compare computerised decision analysis with patient information leaflet. MENTIP study: Menorrhagia Treatment Information and Preferences |
| Scientific title |
|
| Acronym | MENTIP |
| Disease/condition/study domain | Menorrhagia |
| Study hypothesis | Aims:
Since patient information leaflets are highly accessible and relatively cheap, they may be considered the standard against which more complex decision aids must be evaluated.
The purpose of this study is to evaluate whether the addition of decision analysis to written information improves the process of decision-making in women consulting their doctor with heavy periods, compared with written information alone.
Objectives:
To answer the following question: Is the addition of decision analysis to written information significantly more effective at reducing decisional conflict compared with written information alone. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Women aged 30-49 years presenting to GP with heavy periods |
| Participants - exclusion criteria | 1. Women with confirmed or provisional diagnoses of physical pathology (including cancer, endometriosis, fibroids, prolapse and cysts).
2. Women considered by their GP to be unsuitable due to physical or psychological impairment.
3. Women unable to understand English. Because of the nature of the intervention (i.e. a written computer programme), some proficiency in English is required. |
| Patient information material |
|
| Anticipated start date | 01/02/2003 |
| Anticipated end date | 09/09/2005 |
| Status of trial | Completed |
| Target number of participants | 300 |
| Interventions | 1. Control group: Patient Information Leaflet (PIL)
2. Intervention group: PIL and Clinical Guidance Tree (computerised Decision Analysis) |
| Primary outcome measure(s) | The primary outcome measure will be the Decisional Conflict Scale (DCS), a questionnaire developed by O'Connor (1999) for use in studies of decision-making processes. This instrument measures a person's perception of: personal uncertainty in making a choice about health care options, the modifiable factors (such as feeling uninformed, unsupported and unclear about personal values) and the quality of the decision made (in terms of satisfaction with the choice and expectation to maintain). |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17898242 |
| Sources of funding | 1. Medical Research Council (MRC) Special Training Fellowship (UK) (ref: G106/1048)
2. National Primary Care Research And Development Centre (NPCRDC) (UK) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| Contact name | Dr Joanne Protheroe |
| Contact details | NPCRDC
5th Floor Williamson Building
The University of Manchester
Oxford Road
Manchester
United Kingdom
M13 9PL |
| Contact telephone | +44 (0)161 2757601 |
| Contact fax | +44 (0)161 2757600 |
| Contact email | j.protheroe@man.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN72253427 |
| Date last extracted from ISRCTN register | 17/04/2008 |
