Condition category
Urological and Genital Diseases
Date applied
19/02/2003
Date assigned
19/02/2003
Last edited
03/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/02/2003

Overall trial end date

09/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Women aged 30-49 years presenting to GP with heavy periods

Participant type

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17898242

Publication citations

  1. Results

    Protheroe J, Bower P, Chew-Graham C, Peters TJ, Fahey T, Effectiveness of a computerized decision aid in primary care on decision making and quality of life in menorrhagia: results of the MENTIP randomized controlled trial., Med Decis Making, 27, 5, 575-584, doi: 10.1177/0272989X07306785.

Additional files

Editorial Notes