STOOL - Stepped Treatment of Older adults On Laxatives

ISRCTN	ISRCTN11557289
DOI	https://doi.org/10.1186/ISRCTN11557289
Secondary identifying numbers	HTA 98/32/99

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

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

Prof John Bond
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
Email	john.bond@newcastle.ac.uk

Study information

Study design	Pragmatic factorial randomised trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
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	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.
Secondary outcome measures	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
Overall study start date	01/10/2002
Completion date	30/04/2006
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	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

England
United Kingdom

Study participating centre

Centre for Health Services Research

Newcastle upon Tyne
NE2 4AA
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2008		Yes	No