Trial of Lay-led Individualised Self-management Education for Adults With Asthma

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT00129987
• Collaborator: BUPA Foundation (Other)
• Enrollment: 567
• Location: 1
• Arms: 2
• Actual Duration (Months): 33
• Patients Per Site Per Month: 17.2

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Behavioral: Self management education	N/A

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

• Study Type: Interventional
• Actual Enrollment: 567 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Multi-centre Randomised Trial of Lay-led Individualised Self-management Education for Adults With Asthma
• Actual Study Start Date: Nov 1, 2003
• Actual Primary Completion Date: Jul 1, 2006
• Actual Study Completion Date: Aug 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nurse group 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.	Behavioral: Self management education
Experimental: Lay educator group 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.	Behavioral: Self management education

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Unscheduled Use of Healthcare [1 year]

   Healthcare consists of one or other of hospital admission, emergency department attendance, unscheduled consultation with a GP

Secondary Outcome Measures

1. Lung Function [1 year]

   (peak flow measurement)

2. Quality of Life Questionnaires [1 year]

   (MISS-21) with Quality of life questionnaires

3. Number of Participants With Use of Asthma Medication [1 year]

   Number of participants with courses of steriod tablets

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adults step two therapy (BTS)

• Evidence of poorly controlled disease

Exclusion Criteria:

• Unable to benefit from self management education

• Other respiratory conditions other than asthma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NHLI at Charing Cross Hospital Campus	London		United Kingdom	W6 8RF

Sponsors and Collaborators

• Imperial College London
• BUPA Foundation

Investigators

• Principal Investigator: Martyn R Partridge, MD FRCP, NHLI Imperial College

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT00129987
• Other Study ID Numbers: NHLICX3224
• First Posted: Aug 12, 2005
• Last Update Posted: Jan 29, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Imperial College London: Asthma
• Additional relevant MeSH terms: Asthma

Study Results

Participant Flow

Arm/Group Title	Nurse Group	Lay Educator Group
Arm/Group Description	Consultation of asthma patients by nurse	Consultation of asthma patients by lay educator
Period Title: 1st Educational Session
STARTED	287	280
COMPLETED	146	171
NOT COMPLETED	141	109
Period Title: 1st Educational Session
STARTED	146	171
COMPLETED	114	150
NOT COMPLETED	32	21

Baseline Characteristics

Arm/Group Title	Nurse Group	Lay Educator Group	Total
Arm/Group Description	Consultation of asthma patients by nurse	Consultation of asthma patients by lay educator	Total of all reporting groups
Overall Participants	287	280	567
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	251 87.5%	254 90.7%	505 89.1%
>=65 years	36 12.5%	26 9.3%	62 10.9%
Sex: Female, Male (Count of Participants)
Female	104 36.2%	96 34.3%	200 35.3%
Male	183 63.8%	184 65.7%	367 64.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	49 17.1%	42 15%	91 16%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	26 9.1%	20 7.1%	46 8.1%
White	197 68.6%	207 73.9%	404 71.3%
More than one race	10 3.5%	4 1.4%	14 2.5%
Unknown or Not Reported	5 1.7%	7 2.5%	12 2.1%
Region of Enrollment (participants) [Number]
United Kingdom	287 100%	280 100%	567 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Unscheduled Use of Healthcare
Description	Healthcare consists of one or other of hospital admission, emergency department attendance, unscheduled consultation with a GP
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Less participants number due to missing data.

Arm/Group Title	Nurse Group	Lay Educator Group
Arm/Group Description	Consultation of asthma patients by nurse	Consultation of asthma patients by lay educator
Measure Participants	205	213
Count of Participants [Participants]	61 21.3%	65 23.2%

2. Secondary Outcome

Title	Lung Function
Description	(peak flow measurement)
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	Nurse Group	Lay Educator Group
Arm/Group Description	Consultation of asthma patients by nurse	Consultation of asthma patients by lay educator
Measure Participants	0	0

3. Secondary Outcome

Title	Quality of Life Questionnaires
Description	(MISS-21) with Quality of life questionnaires
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	Nurse Group	Lay Educator Group
Arm/Group Description	Consultation of asthma patients by nurse	Consultation of asthma patients by lay educator
Measure Participants	0	0

4. Secondary Outcome

Title	Number of Participants With Use of Asthma Medication
Description	Number of participants with courses of steriod tablets
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Less participants number due to missing data.

Arm/Group Title	Nurse Group	Lay Educator Group
Arm/Group Description	Consultation of asthma patients by nurse	Consultation of asthma patients by lay educator
Measure Participants	205	213
Count of Participants [Participants]	60 20.9%	62 22.1%

Adverse Events

Time Frame	1 year
Arm/Group Title	Nurse Group		Lay Educator Group
Arm/Group Description	Consultation of asthma patients by nurse		Consultation of asthma patients by lay educator
All Cause Mortality
	Nurse Group		Lay Educator Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/205 (0%)		0/213 (0%)
Serious Adverse Events
	Nurse Group		Lay Educator Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/205 (0%)		0/213 (0%)
Other (Not Including Serious) Adverse Events
	Nurse Group		Lay Educator Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/205 (0%)		0/213 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.