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Diet and lifestyle vs laxatives in the management of chronic constipation in older people
DOI 10.1186/ISRCTN73881345
ClinicalTrials.gov identifier
EudraCT number
Public title Diet and lifestyle vs laxatives in the management of chronic constipation in older people
Scientific title
Serial number at source HTA 01/10/04
Study hypothesis Constipation is a common chronic condition, with considerable costs to the NHS in terms of GP consultations and prescribed laxatives. A systematic literature review has found weak evidence that laxatives can improve stool frequency and consistency and can alleviate related symptoms in older people. Dietary and lifestyle interventions have also been shown to alleviate constipation. More generally, in studies aimed at the modification of individual health-related behaviour, brief interventions have been shown to have limited effect while intensive, patient-tailored interventions have been more effective though costly. The proposed study will compare the effectiveness and cost-effectiveness of brief and intensive lifestyle interventions with medical management in treating chronic constipation in older people.

Main aims:
1. To investigate the clinical and cost-effectiveness of laxatives versus dietary and lifestyle advice.
2. To investigate the clinical and cost-effectiveness of brief, standardised versus personalised dietary and lifestyle advice.

Secondary aims:
1. To describe the adherence by patients to treatment protocols and to estimate its impact on cost-effectiveness.
2. To describe the adherence by health care professionals to intervention protocols.

More information can be found at: http://www.hta.ac.uk/1310
Protocol can be found at: http://www.hta.ac.uk/protocols/200100100004.pdf

Please note that, as of 17 January 2008, the start and anticipated end date of this trial have been updated from 1 October 2002 and 30 April 2006 to 1 June 2003 and 30 September 2008, respectively.

Please note that, as of 24/08/2009, the HTA reference number has been amended from HTA 10/01/04 to HTA 01/10/04.
Lay summary
Ethics approval Not provided at time of registration.
Study design Pragmatic cluster randomised trial
Countries of recruitment United Kingdom
Disease/condition/study domain Chronic functional constipation
Participants - inclusion criteria Older adults (aged 55 and over) with prevalent chronic constipation
Participants - exclusion criteria Added May 2008:
1. Patients resident in long-term care
2. Patients with inflammatory bowel disease, intestinal obstruction/bowel strictures, known colonic carcinoma and conditions contra-indicative to the prescription of laxative preparations
3. Inability to read and understand written treatment plans and educational material
4. Inability to complete outcome assessments, even with assistance (eg major cognitive impairment, lack of understanding of English)
Anticipated start date 01/06/2003
Anticipated end date 30/09/2008
Status of trial Completed
Patient information material
Target number of participants Added May 2008: 27 GP practices
Interventions A prospective, pragmatic cluster randomised (at the level of the general practice) trial, with three arms: 1. Laxatives of GP's choice 2. Brief, standardised dietary and lifestyle advice 3. Intensive, personalised dietary and lifestyle advice. The trial will incorporate an economic evaluation and patients will be followed up for 12 months post-enrolment.
A qualitative component will investigate barriers to and facilitators of adherence to treatment protocols and interventions from the perspective of both patients and practice staff.
Primary outcome measure(s) Quality of life related to constipation.
Secondary outcome measure(s) Frequency and severity of symptoms of constipation; subjective perceptions of whether constipated; satisfaction with bowel function; compliance with therapy; treatment side effects and adverse events; relapse and re-consultation rates.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 1. 2007 protocol on the development and piloting of the patient information leaflets in http://www.ncbi.nlm.nih.gov/pubmed/17204144
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21059322
Contact name Ms  Elaine  McColl
  Address Centre for Health Services Research,
University of Newcastle upon Tyne,
21 Claremont Place
  City/town Newcastle upon Tyne
  Zip/Postcode NE2 4AA
  Country United Kingdom
  Tel +44 (0)191 222 7260
  Fax +44 (0)191 222 6043
  Email e.mccoll@newcastle.ac.uk
Sponsor Department of Health (UK)
  Address Quarry House
Quarry Hill
  City/town Leeds
  Zip/Postcode LS2 7UE
  Country United Kingdom
  Tel +44 (0)1132 545 843
  Email Sheila.Greener@doh.gsi.gov.uk
  Sponsor website: http://www.dh.gov.uk/en/index.htm
Date applied 30/06/2003
Last edited 02/03/2011
Date ISRCTN assigned 14/07/2003
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