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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN72253427 |
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Date of registration:
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19/02/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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Date of first enrolment:
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01/02/2003 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN72253427 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Joanne
Protheroe |
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Address:
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NPCRDC
5th Floor Williamson Building
The University of Manchester
Oxford Road
M13 9PL
Manchester
United Kingdom |
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Telephone:
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+44 (0)161 2757601 |
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Email:
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j.protheroe@man.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Women aged 30-49 years presenting to GP with heavy periods
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.
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Menorrhagia
Urological and Genital Diseases
Menorrhagia
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Intervention(s)
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1. Control group: Patient Information Leaflet (PIL)
2. Intervention group: PIL and Clinical Guidance Tree (computerised Decision Analysis)
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Primary Outcome(s)
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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).
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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G106/1048
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Source(s) of Monetary Support
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Medical Research Council (MRC) Special Training Fellowship (UK) (ref: G106/1048), National Primary Care Research And Development Centre (NPCRDC) (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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