AsthmaNCT00129987
Trial of Lay-led Individualised Self-management Education for Adults With Asthma
A study testing Self management education in people with Asthma, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Long term conditions often necessitate long term care. In many cases, giving control of their conditions to the patients themselves produces the best outcomes. Such patient education and the acquisition of self-management skills can be time consuming and the evidence suggests that the process is often not undertaken… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Self management education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 567 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2003to Aug 2006
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults step two therapy (BTS)
- Evidence of poorly controlled disease
Who cannot join
- Unable to benefit from self management education
- Other respiratory conditions other than asthma
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NHLI at Charing Cross Hospital Campus
London, W6 8RF
About this study
Official title: A Multi-centre Randomised Trial of Lay-led Individualised Self-management Education for Adults With Asthma
Long term conditions often necessitate long term care. In many cases, giving control of their conditions to the patients themselves produces the best outcomes. Such patient education and the acquisition of self-management skills can be time consuming and the evidence suggests that the process is often not undertaken by doctors. Sometimes it is delegated to nursing colleagues, but all health professionals are in short supply. Patients carry credibility as a resource and this project is designed to determine, by means of a multi-centre randomised controlled trial, whether well trained lay educators can deliver training in self-management education to others with asthma, with outcomes equivalent to those achievable by a nurse.
Read the detailed description
This study will be a randomised controlled trial looking for equivalence; the investigators' central hypothesis is that lay-led education will be at least equivalent to professional-led education in terms of patient outcomes. Patients will be randomised to receive either lay-led or professional led self-management education. Patients will be followed up longitudinally for 12 months from initial intervention. Two sites were studied; Manchester and London. It is anticipated that 16 sites will be recruited in each of the two geographical areas; all sites will have an asthma register. Individuals will be eligible for inclusion if they are adults; have clinician diagnosed asthma; have persistent disease and require regular therapy, with some evidence of variability in their disease, such that a self management plan would be appropriate. Both genders will be eligible, as will those unable to see or read. Individuals will be excluded if they have severe cognitive impairment; they decline to be randomised; they decline to receive asthma education and follow-up solely from the designated educator, other than in an emergency situation, or their condition does not show variability.
The intervention in the study will be a disease-specific asthma self-management education programme delivery either by a professional (ie practice nurse) or a lay educator. Both lay and professional trainers will receive specific training in the content and delivery of this intervention. The intervention will consist of an initial 45 minute training session (including receipt of a written personal asthma action plan); a second face to face reinforcing session 3 weeks after the first session; 3 monthly telephone follow-up appointments to reinforce messages and to give ongoing advice with availability of the nurse or lay educator as a source of advice at all other times. Data will be collected on unscheduled use of health care, peak flow readings, patients' self-reporting of "adverse events", RCP three questions, perceptions of the interviews using MISS-21, QOL questionnaire and AQLQ. Demographics for all patients will also be recorded.
- Conditions
- Asthma
- Being tested
- Self management education
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self management educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Nurse group | Experimental | An initial consultation of up to 45 min offered either by a practice based primary care nurse, followed by a second shorter face to face consultation and telephone follow-up for 1 year. Receives: Behavioral: Self management education |
| Lay educator group | Experimental | An initial consultation of up to 45 min offered either by a lay educator, followed by a second shorter face to face consultation and telephone follow-up for 1 year. Receives: Behavioral: Self management education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Unscheduled Use of Healthcare
Healthcare consists of one or other of hospital admission, emergency department attendance, unscheduled consultation with a GP
Measured: 1 year
Secondary outcomes (3)
Lung Function
(peak flow measurement)
Measured: 1 year
Quality of Life Questionnaires
(MISS-21) with Quality of life questionnaires
Measured: 1 year
Number of Participants With Use of Asthma Medication
Number of participants with courses of steriod tablets
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2005 (estimated)
- Study startNov 2003
- Primary completionJul 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Bupa Chile
- Responsible party
- Sponsor
- Investigators
- Martyn R Partridge, MD FRCP, Principal investigator, NHLI Imperial College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129987
- Sponsor's protocol ID
- NHLICX3224
- Status last verified
- Jan 2020
- First submitted
- 11 Aug 2005
- Last updated
- 29 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allen D. Telephone follow up for older people discharged from A&E. Nurs Stand. 1997 Aug 6;11(46):34-7. doi: 10.7748/ns1997.08.11.46.34.c2470.
PubMed 9325984Alter CL, Fleishman SB, Kornblith AB, Holland JC, Biano D, Levenson R, Vinciguerra V, Rai KR. Supportive telephone intervention for patients receiving chemotherapy. A pilot study. Psychosomatics. 1996 Sep-Oct;37(5):425-31. doi: 10.1016/S0033-3182(96)71529-3.
PubMed 8824121Ayres JG, Campbell LM. A controlled assessment of an asthma self-management plan involving a budesonide dose regimen. OPTIONS Research Group. Eur Respir J. 1996 May;9(5):886-92. doi: 10.1183/09031936.96.09050886.
PubMed 8793447British Thoracic Society, National Asthma Campaign et al (1997) The British Guidelines on Asthma Management 1995 Review and Position Statement Thorax 52 (suppl 1): S1 -S21
Caress A, Beaver K, Woodcock A, Luker K (2002a) A descriptive study of treatment decision-making role preference in adult asthma patients American Journal of Respiratory and Critical Care Medicine 165 (8) A420
Caress A, Beaver K, Luker K and Woodcock A (2002b) A cross-sectional survey of priority information needs in adult asthma patients American Journal of Respiratory and Critical Care Medicine 165 (8) A43
Chen JT, Krieger N, Van Den Eeden SK, Quesenberry CP. Different slopes for different folks: socioeconomic and racial/ethnic disparities in asthma and hay fever among 173,859 U.S. men and women. Environ Health Perspect. 2002 Apr;110 Suppl 2(Suppl 2):211-6. doi: 10.1289/ehp.02110s2211.
PubMed 11929730Crone S. Launching a national helpline. Health Visit. 1993 Mar;66(3):94-6.
PubMed 8491650Degner LF, Davison BJ, Sloan JA, Mueller B. Development of a scale to measure information needs in cancer care. J Nurs Meas. 1998 Winter;6(2):137-53.
PubMed 10028780Denzin N. (1970) The Research Act: A Theoretical Introduction to Social Research Chicago: Aldine
Department of Health (2001) The Expert Patient: a New Approach to Chronic Disease Management for the 21st Century London: The Stationery Office
Drummond MF, O'Brien B, Stoddart GL, Torrance GW (1997) Methods for the Economic Evaluation of Healthcare Programmes Oxford: Oxford University Press
Field KS, Briggs DJ. Socio-economic and locational determinants of accessibility and utilization of primary health-care. Health Soc Care Community. 2001 Sep;9(5):294-308. doi: 10.1046/j.0966-0410.2001.00303.x.
PubMed 11560745Gibson PG, Coughlan J, Wilson AJ, Abramson M, Bauman A, Hensley MJ, Walters EH. Self-management education and regular practitioner review for adults with asthma. Cochrane Database Syst Rev. 2000;2002(2):CD001117. doi: 10.1002/14651858.CD001117.
PubMed 10796600Gilthorpe MS, Lay-Yee R, Wilson RC, Walters S, Griffiths RK, Bedi R. Variations in hospitalization rates for asthma among black and minority ethnic communities. Respir Med. 1998 Apr;92(4):642-8. doi: 10.1016/s0954-6111(98)90511-x.
PubMed 9659530
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Randomised Trial of Lay-led Individualised Self-management Education for Adults With Asthma
- ClinicalTrials.gov ID
- NCT00129987
- Acronym / sponsor ID
- NHLICX3224
- Conditions
- Asthma
- Keywords
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Bupa Chile
- Study start
- Nov 2003 (actual)
- Primary completion
- Jul 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 12 Aug 2005 (estimated)
- Results
- Posted 29 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long term conditions often necessitate long term care. In many cases, giving control of their conditions to the patients themselves produces the best outcomes. Such patient education and the acquisition of self-management skills can be time consuming and the evidence suggests that the process is often not undertaken by doctors. Sometimes it is delegated to nursing colleagues, but all health professionals are in short supply. Patients carry credibility as a resource and this project is designed to determine, by means of a multi-centre randomised controlled trial, whether well trained lay educators can deliver training in self-management education to others with asthma, with outcomes equivalent to those achievable by a nurse.
Detailed description
This study will be a randomised controlled trial looking for equivalence; the investigators' central hypothesis is that lay-led education will be at least equivalent to professional-led education in terms of patient outcomes. Patients will be randomised to receive either lay-led or professional led self-management education. Patients will be followed up longitudinally for 12 months from initial intervention. Two sites were studied; Manchester and London. It is anticipated that 16 sites will be recruited in each of the two geographical areas; all sites will have an asthma register. Individuals will be eligible for inclusion if they are adults; have clinician diagnosed asthma; have persistent disease and require regular therapy, with some evidence of variability in their disease, such that a self management plan would be appropriate. Both genders will be eligible, as will those unable to see or read. Individuals will be excluded if they have severe cognitive impairment; they decline to be randomised; they decline to receive asthma education and follow-up solely from the designated educator, other than in an emergency situation, or their condition does not show variability.
The intervention in the study will be a disease-specific asthma self-management education programme delivery either by a professional (ie practice nurse) or a lay educator. Both lay and professional trainers will receive specific training in the content and delivery of this intervention. The intervention will consist of an initial 45 minute training session (including receipt of a written personal asthma action plan); a second face to face reinforcing session 3 weeks after the first session; 3 monthly telephone follow-up appointments to reinforce messages and to give ongoing advice with availability of the nurse or lay educator as a source of advice at all other times. Data will be collected on unscheduled use of health care, peak flow readings, patients' self-reporting of "adverse events", RCP three questions, perceptions of the interviews using MISS-21, QOL questionnaire and AQLQ. Demographics for all patients will also be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse group | Experimental | Behavioral: Self management educationAn initial consultation of up to 45 min offered either by a practice based primary care nurse, followed by a second shorter face to face consultation and telephone follow-up for 1 year. |
| Lay educator group | Experimental | Behavioral: Self management educationAn initial consultation of up to 45 min offered either by a lay educator, followed by a second shorter face to face consultation and telephone follow-up for 1 year. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults step two therapy (BTS)
- Evidence of poorly controlled disease
Key exclusion criteria (2 listed)
- Unable to benefit from self management education
- Other respiratory conditions other than asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self management education | Behavioural | Lay educator group, Nurse group |
Primary outcome
Number of Participants With Unscheduled Use of Healthcare
Time frame: 1 year
Healthcare consists of one or other of hospital admission, emergency department attendance, unscheduled consultation with a GP
3 secondary outcomes
Lung Function
Time frame: 1 year
Quality of Life Questionnaires
Time frame: 1 year
Number of Participants With Use of Asthma Medication
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9325984Allen D. Telephone follow up for older people discharged from A&E. Nurs Stand. 1997 Aug 6;11(46):34-7. doi: 10.7748/ns1997.08.11.46.34.c2470.
- Background: PubMed 8824121Alter CL, Fleishman SB, Kornblith AB, Holland JC, Biano D, Levenson R, Vinciguerra V, Rai KR. Supportive telephone intervention for patients receiving chemotherapy. A pilot study. Psychosomatics. 1996 Sep-Oct;37(5):425-31. doi: 10.1016/S0033-3182(96)71529-3.
- Background: PubMed 8793447Ayres JG, Campbell LM. A controlled assessment of an asthma self-management plan involving a budesonide dose regimen. OPTIONS Research Group. Eur Respir J. 1996 May;9(5):886-92. doi: 10.1183/09031936.96.09050886.
- BackgroundBritish Thoracic Society, National Asthma Campaign et al (1997) The British Guidelines on Asthma Management 1995 Review and Position Statement Thorax 52 (suppl 1): S1 -S21
- BackgroundCaress A, Beaver K, Woodcock A, Luker K (2002a) A descriptive study of treatment decision-making role preference in adult asthma patients American Journal of Respiratory and Critical Care Medicine 165 (8) A420
- BackgroundCaress A, Beaver K, Luker K and Woodcock A (2002b) A cross-sectional survey of priority information needs in adult asthma patients American Journal of Respiratory and Critical Care Medicine 165 (8) A43
- Background: PubMed 11929730Chen JT, Krieger N, Van Den Eeden SK, Quesenberry CP. Different slopes for different folks: socioeconomic and racial/ethnic disparities in asthma and hay fever among 173,859 U.S. men and women. Environ Health Perspect. 2002 Apr;110 Suppl 2(Suppl 2):211-6. doi: 10.1289/ehp.02110s2211.
- Background: PubMed 8491650Crone S. Launching a national helpline. Health Visit. 1993 Mar;66(3):94-6.
- Background: PubMed 10028780Degner LF, Davison BJ, Sloan JA, Mueller B. Development of a scale to measure information needs in cancer care. J Nurs Meas. 1998 Winter;6(2):137-53.
- BackgroundDenzin N. (1970) The Research Act: A Theoretical Introduction to Social Research Chicago: Aldine
- BackgroundDepartment of Health (2001) The Expert Patient: a New Approach to Chronic Disease Management for the 21st Century London: The Stationery Office
- BackgroundDrummond MF, O'Brien B, Stoddart GL, Torrance GW (1997) Methods for the Economic Evaluation of Healthcare Programmes Oxford: Oxford University Press
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martyn R Partridge, MD FRCP principal investigator
NHLI Imperial College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self management education in people with Asthma, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Unscheduled Use of Healthcare (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00129987, which also lists 47 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.