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| Name | Class |
|---|---|
| Bupa Chile | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self management education | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Function | (peak flow measurement) | 1 year |
| Quality of Life Questionnaires | (MISS-21) with Quality of life questionnaires | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martyn R Partridge, MD FRCP | NHLI Imperial College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHLI at Charing Cross Hospital Campus | London | W6 8RF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9325984 | Background | 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. | |
| 8824121 | Background | Alter 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nurse Group | Consultation of asthma patients by nurse |
| FG001 | Lay Educator Group | Consultation of asthma patients by lay educator |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Educational Session |
|
| ||||||||||||||||||
| 1 Year |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nurse Group | Consultation of asthma patients by nurse |
| BG001 | Lay Educator Group | Consultation of asthma patients by lay educator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Less participants number due to missing data. | Posted | Count of Participants | Participants | 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nurse Group | Consultation of asthma patients by nurse | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martyn R Patridge | Imperial College London | +44 (0)20 7594 7959 | m.patridge@imperial.ac.uk |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Number of Participants With Use of Asthma Medication | Number of participants with courses of steriod tablets | 1 year |
| 8793447 | Background | Ayres 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. |
| Background | British 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 |
| Background | 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 |
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| 10679533 | Background | Partridge MR. In what way may race, ethnicity or culture influence asthma outcomes? Thorax. 2000 Mar;55(3):175-6. doi: 10.1136/thorax.55.3.175. No abstract available. |
| 10968512 | Background | Partridge MR, Hill SR. Enhancing care for people with asthma: the role of communication, education, training and self-management. 1998 World Asthma Meeting Education and Delivery of Care Working Group. Eur Respir J. 2000 Aug;16(2):333-48. doi: 10.1183/09031936.00.16233400. |
| Background | Pearson MG and Bucknall CE (1999) Measuring clinical outcome in asthma - a patient focused approach. London: Royal College of Physicians of London |
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| 18281394 | Result | Partridge MR, Caress AL, Brown C, Hennings J, Luker K, Woodcock A, Campbell M. Can lay people deliver asthma self-management education as effectively as primary care based practice nurses? Thorax. 2008 Sep;63(9):778-83. doi: 10.1136/thx.2007.084251. Epub 2008 Feb 15. |
| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Lung Function | (peak flow measurement) | Data not collected | Posted | 1 year |
|
|
| Secondary | Quality of Life Questionnaires | (MISS-21) with Quality of life questionnaires | Data not collected | Posted | 1 year |
|
|
| Secondary | Number of Participants With Use of Asthma Medication | Number of participants with courses of steriod tablets | Less participants number due to missing data. | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 205 |
| 0 |
| 205 |
| 0 |
| 205 |
| EG001 | Lay Educator Group | Consultation of asthma patients by lay educator | 0 | 213 | 0 | 213 | 0 | 213 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |