Condition category
Digestive System
Date applied
30/06/2003
Date assigned
14/07/2003
Last edited
02/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Elaine McColl

ORCID ID

Contact details

Centre for Health Services Research
University of Newcastle upon Tyne
21 Claremont Place
Newcastle upon Tyne
NE2 4AA
United Kingdom
+44 (0)191 222 7260
e.mccoll@newcastle.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 01/10/04

Study information

Scientific title

Acronym

LIFELAX

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.

Ethics approval

Not provided at time of registration.

Study design

Pragmatic cluster randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Chronic functional constipation

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Quality of life related to constipation.

Secondary outcome measures

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.

Overall trial start date

01/06/2003

Overall trial end date

30/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Older adults (aged 55 and over) with prevalent chronic constipation

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Added May 2008: 27 GP practices

Participant 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)

Recruitment start date

01/06/2003

Recruitment end date

30/09/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Health Services Research,
Newcastle upon Tyne
NE2 4AA
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    Speed C, Heaven B, Adamson A, Bond J, Corbett S, Lake AA, May C, Vanoli A, McMeekin P, Moynihan P, Rubin G, Steen IN, McColl E, LIFELAX - diet and LIFEstyle versus LAXatives in the management of chronic constipation in older people: randomised controlled trial., Health Technol Assess, 2010, 14, 52, 1-251, doi: 10.3310/hta14520.

  2. Lake AA, Speed C, Brookes A, Heaven B, Adamson AJ, Moynihan P, Corbett S, McColl E, Development of a series of patient information leaflets for constipation using a range of cognitive interview techniques: LIFELAX., BMC Health Serv Res, 2007, 7, 3, doi: 10.1186/1472-6963-7-3.

Additional files

Editorial Notes