Condition category
Digestive System
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
02/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.npcrdc.man.ac.uk/ResearchDetail.cfm?ID=8

Contact information

Type

Scientific

Primary contact

Dr Anne Kennedy

ORCID ID

Contact details

National Primary Care Research & Development Centre
University of Manchester
5th Floor
Williamson Building
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 7620
akennedy@fs1.cprc.man.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 96/11/02

Study information

Scientific title

Acronym

Study hypothesis

To determine if an expensive, comprehensive guidebook promoting patient choice combined with physicians trained in patient-centred care and use of the guidebook improves patient satisfaction, health, quality of life, perceptions of control, anxiety levels, ability to self-treat and leads to cost effective use of NHS services.

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Inflammatory bowel disease

Intervention

A multi-centre (16 centres, 40 subjects from each centre, 640 in total) 2-armed RCT, comparing benefits of guidebook plus patient-centred care versus standard patient care using validated questionnaires, patients diaries and qualitative interviews with patients and clinicians.
1. Guidebook plus patient-centred care
2. Standard patient care using validated questionnaires, patients diaries and qualitative interviews with patients and clinicians.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Patient satisfaction
2. Health
3. Quality of life
4. Perceptions of control
5. Anxiety levels
6. Ability to self-treat
7. Cost effective use of NHS services.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1999

Overall trial end date

31/12/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Established ulcerative colitis or Crohn's disease
2. 16 years +
3. Able to write English
4. Attending follow-up clinics

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

640

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1999

Recruitment end date

31/12/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

National Primary Care Research & Development Centre
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

2003 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/14567905

Publication citations

  1. HTA monograph

    Kennedy A, Nelson E, Reeves D, Richardson G, Roberts C, Robinson A, Rogers A, Sculpher M, Thompson D, A randomised controlled trial to assess the impact of a package comprising a patient-orientated, evidence-based self-help guidebook and patient-centred consultations on disease management and satisfaction in inflammatory bowel disease., Health Technol Assess, 2003, 7, 28, iii, 1-113.

Additional files

Editorial Notes