STOOL - Stepped Treatment of Older adults On Laxatives
| ISRCTN | ISRCTN11557289 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11557289 |
| Protocol serial number | HTA 98/32/99 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 25/08/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Digestive System
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Centre for Health Services Research
University of Newcastle upon Tyne
21 Claremont Place
Newcastle upon Tyne
NE2 4AA
United Kingdom
| Phone | +44 (0)191 222 6777 |
|---|---|
| john.bond@newcastle.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pragmatic factorial randomised trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | STOOL |
| Study objectives | 1. To investigate the clinical and cost effectiveness of bulk forming, stimulant and osmotic laxatives prescribed by primary care to ambulant older people living at home. 2. To investigate the clinical and cost effectiveness of prescribing an additional second type of laxative agent in the treatment of patients whose constipation is not resolved by a single agent. 3. To describe the adherence by patients to treatment protocols. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Constipation |
| Intervention | Different forms of stepped pharmacological treatment of constipation with economic evaluation. An add-on qualitative study of the meaning and experience of constipation to older people and the views of general practitioners. Added as of 25/08/2009: the trial was closed after recruiting 19 participants due to problem with recruitment. |
| Intervention type | Other |
| Primary outcome measure(s) |
The primary clinical outcome is the reported number of bowel movements per week at the end of each step (6 and 10 weeks after randomisation) and at six months follow-up. |
| Key secondary outcome measure(s) |
Secondary clinical outcomes include the presence/absence of the other Rome criteria for constipation; adverse effects of treatment (although some of these may also be symptoms of constipation); and relapse rates. In addition to the measurement of these clinical outcomes, patient satisfaction and the impact of the treatment on costs and quality of life will be assessed |
| Completion date | 30/04/2006 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 19 |
| Key inclusion criteria | People aged 55 or over with chronic constipation living in private households. |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/10/2002 |
| Date of final enrolment | 30/04/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
NE2 4AA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2008 | Yes | No |
