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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18598681
Enrollment
640
Registered
2003-04-25
Start date
1999-01-01
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease Digestive System Crohn's disease [regional enteritis]

Interventions

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 questionnair

Sponsors

Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Not provided at time of registration—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026