Introduction of a community-based intervention for children with chronic constipation
| ISRCTN | ISRCTN07833068 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07833068 |
| Secondary identifying numbers | N0045126756 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 29/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Susan Protheroe
Scientific
Scientific
Birmingham Children's Hospital
Department of Gastroenterology
Steelhouse Lane
Birmingham
B4 6NH
United Kingdom
| Phone | +44 (0)121 333 8720 |
|---|---|
| Sue.protheroe@bch.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Introduction of a community-based intervention for children with chronic constipation |
| Study objectives | To assess the effect of the introduction of a primary care-based intervention for children with constipation compared to conventional hospital based management. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Digestive System: Constipation |
| Intervention | A randomised controlled trial to compare a new nurse-led service with conventional hospital-based management for children with constipation. |
| Intervention type | Other |
| Primary outcome measure | 1. Clinical outcomes: remission and relapse of symptoms 2. Quality of life/patient and parental satisfaction 3. Cost benefits: on-going treatment, nurse contacts, out-patient visits and hospital admission |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/04/2003 |
| Completion date | 31/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 40 children aged 2-15 years with moderate to severe chronic constipation referred to gastroenterologists and general paediatricians in Birmingham Children's Hospital NHS Trust. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 31/03/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Birmingham Children's Hospital
Birmingham
B4 6NH
United Kingdom
B4 6NH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Birmingham Children's Hospital NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
29/04/2016: No publications found, verifying study status with principal investigator
