Contact information
Type
Scientific
Contact name
Dr Joanne Protheroe
ORCID ID
Contact details
NPCRDC
5th Floor Williamson Building
The University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 2757601
j.protheroe@man.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
G106/1048
Study information
Scientific title
Acronym
MENTIP
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.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
GP practice
Study type
Treatment
Patient information sheet
Condition
Menorrhagia
Intervention
1. Control group: Patient Information Leaflet (PIL)
2. Intervention group: PIL and Clinical Guidance Tree (computerised Decision Analysis)
Intervention type
Other
Primary outcome measure
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 measures
Not provided at time of registration
Overall study start date
01/02/2003
Overall study end date
09/09/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women aged 30-49 years presenting to GP with heavy periods
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
300
Participant 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.
Recruitment start date
01/02/2003
Recruitment end date
09/09/2005
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
NPCRDC
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) Special Training Fellowship (UK) (ref: G106/1048)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Primary Care Research And Development Centre (NPCRDC) (UK)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/09/2007 | Yes | No |