Diet and lifestyle vs laxatives in the management of chronic constipation in older people
| ISRCTN | ISRCTN73881345 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73881345 |
| Secondary identifying numbers | HTA 01/10/04 |
- Submission date
- 30/06/2003
- Registration date
- 14/07/2003
- Last edited
- 02/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Ms Elaine McColl
Scientific
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 7260 |
|---|---|
| e.mccoll@newcastle.ac.uk |
Study information
| Study design | Pragmatic cluster randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | |
| Study 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(s) | Not provided at time of registration. |
| 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 |
| Primary outcome measure | 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 study start date | 01/06/2003 |
| Overall study end date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Added May 2008: 27 GP practices |
| Participant inclusion criteria | Older adults (aged 55 and over) with prevalent chronic constipation |
| 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
- England
- United Kingdom
Study participating centre
Centre for Health Services Research,
Newcastle upon Tyne
NE2 4AA
United Kingdom
NE2 4AA
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| 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? |
|---|---|---|---|---|---|
| Protocol article | protocol on the development and piloting of the patient information leaflets | 04/01/2007 | Yes | No | |
| Results article | results | 01/11/2010 | Yes | No |
