Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512837
Status:
COMPLETED
Last Update Posted:
2016-01-21
First Post:
2007-08-07
Brief Title:
Mobile Phone Based Structured Intervention
Sponsor:
University of Aberdeen
Organization:
University of Aberdeen
Study Overview
Official Title:
A Mobile Phone Based Structured Intervention to Achieve Asthma Control in Patients With Uncontrolled Persistent Asthma Pragmatic Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although asthma outcomes can be improved with structured care less than half of people with asthma achieve good control Part of the problem is poor adherence with self-monitoring and preventive drug regimes This trial will test whether using mobile phone-based monitoring as part of a structured care plan improves clinical outcomes and confidence in people with poorly controlled asthma
Adults and teenagers with poorly controlled asthma will be recruited and randomly assigned to one of two groups Those in the mobile phone group will monitor their asthma daily using their mobile phone to record symptoms medication and lung function Instantaneous feedback to their phone will provide a visual indication of asthma control and prompts about therapy The patient and their clinician will have web-based access to all readings People in the control group will use traditional paper-based monitoring Under the care of their asthma nurse both groups will be treated according to the step-wise approach of the BTSSIGN asthma guideline in order to gain control
We will use the validated Asthma Control Questionnaire to measure control at baseline three and six months and compare improvement in the two groups We will also assess how confident people feel in controlling their asthma using a validated measure of self-efficacy attitudes and knowledge
Technological solutions to long-term healthcare problems are increasingly being sought by patients clinicians and policy makers If successful our trial could provide timely evidence for the use of information technology to address the long-recognised problem of poor asthma control
Adults and teenagers with poorly controlled asthma will be recruited and randomly assigned to one of two groups Those in the mobile phone group will monitor their asthma daily using their mobile phone to record symptoms medication and lung function Instantaneous feedback to their phone will provide a visual indication of asthma control and prompts about therapy The patient and their clinician will have web-based access to all readings People in the control group will use traditional paper-based monitoring Under the care of their asthma nurse both groups will be treated according to the step-wise approach of the BTSSIGN asthma guideline in order to gain control
We will use the validated Asthma Control Questionnaire to measure control at baseline three and six months and compare improvement in the two groups We will also assess how confident people feel in controlling their asthma using a validated measure of self-efficacy attitudes and knowledge
Technological solutions to long-term healthcare problems are increasingly being sought by patients clinicians and policy makers If successful our trial could provide timely evidence for the use of information technology to address the long-recognised problem of poor asthma control
Detailed Description:
A Hypothesis In teenagers and adults with poorly controlled asthma offered treatment according to BTS-SIGN guideline the use of mobile phone-based lung function and symptom monitoring with patient feedback will improve the asthma control achieved and patient self-efficacy at six-months compared to usual paper-based monitoring strategies
B Background Despite effective treatments studies continue to demonstrate that asthma is poorly controlled12 though marked variation in the control achieved in UK general practices suggests that improvement is possible for the vast majority of patients3 Psychosocial factors such as denial of illness low outcome expectations 45 and hectic lifestyles exacerbated by limited knowledge poor self-recognition of symptoms and discordant attitudes influence patients ability to engage in self-management with resultant poor concordance with monitoring and treatment67 Interventions involving biofeedback can address these barriers by objectively demonstrating symptom severity and the impact of medication compliance8 A Cochrane review demonstrates that self-management education linked with structured care improves asthma outcomes9 Despite self-management education6 in real life compliance with traditional diary monitoring can be as low as 610 and results are often fabricated11 Electronic recording may improve compliance12 with over two-thirds of potential readings recorded over a 72-week trial13 Increasingly pervasive throughout society mobile phone technology provides a convenient portable communications medium Mobile phone-based monitoring with supporting biofeedback appears able to engage patients in their management resulting in high levels of adherence and patient acceptability1314 with many patients welcoming the innovative care15161718 Integrated within a structured care protocol this has the potential to address the barriers of poor adherence and low expectations and thereby to improve patient outcomes
Monitoring is in itself an intervention which alters behaviour The theoretical model developed by Glasziou et al describes the complementary and evolving roles of periodic professional reviews and on-going patient self-monitoring19 The monitoring of asthma with lung function andor symptoms is cited as a well-defined exemplar of this concept Our recent qualitative study suggests that people with asthma perceive a role for mobile technology in aiding transition from clinician-supported phases while control is gained to effective self-management during maintenance phases20 This approach resonates with two key health service policies the drive for technological solutions to healthcare problems21 and the importance of expert patients and self-management of long-term conditions2223 Our proposed trial tests the hypothesis that through engaging the patient in self-monitoring with timely biofeedback mobile phone technology can improve the asthma control achieved at six months compared to usual paper-based monitoring
Our multi-disciplinary team has extensive experience of tele-care delivery of primary care respiratory services patient self-management and research within general practice settings Building on extensive background work313-15171820 we offer expertise in respiratory and health services research and social science and are ideally placed to undertake this trial
Description of the mobile phone-based monitoring system see figure The system software T asthma Oxford UK can be loaded onto any web-enabled mobile phone It permits recording of symptoms medication usage and lung function Measurements are made with a Piko meter a prescribable electronic meter which records both FEV1 and peak expiratory flow PEF We have opted to record FEV1 because it is a component of the ACQ24 and the correlation between Piko and spirometry FEV1 is excellent r0982526 Data transmitted to a remote server are analysed and the latest reading returned to the mobile phone compared with the preceding weeks recordings and a prompt for using preventer medication In addition the patient and their clinician can access the record via a password-protected websiteC Design of the research A six month single-blinded randomised controlled trial
Practice recruitment Sixeight practices total list 72000 patients will be recruited from the Leicester area local to the practice of a lead co-applicant Eligible practices will have an asthma-trained nurse able to commit to the additional clinical workload
Participant recruitment Practices will use the Minimal Asthma Assessment Tool MAAT which interrogates routinely collected data on their computer database using patterns of medication usage symptom control and biometric data to identify patients 12 years and over with poorly controlled asthma3 Potential eligibility will be confirmed by inspection of manualcomputer records checking and documenting exclusion criteria other significant lung disease under specialist care for severedifficult asthma unable to communicate in English or use a mobile phone and at the request of the GP for other significant socialclinical problems The practice will invite all potentially eligible patients by post to participate
Confirmation of eligibility and baseline assessment Potential participants will attend a screening assessment normally in their practice at which eligibility will be confirmed their current asthma control assessed using the ACQ24 and suitability of their mobile phone established All patients with poorly controlled asthma defined as ACQ15 27 will be entered in the trial and a baseline assessment undertakensee summary table
Randomisation Patients will be allocated using centralised randomisation stratified by practice to mobile phone or paper-based monitoring The University of Aberdeens Health Services Research Unit will provide a 24hr telephone randomisation service
Intervention group Mobile phone based monitoring Patients in the intervention group will be issued with a Piko meter and the T software loaded onto their mobile phone They will be asked to monitor symptoms medication usage and FEV1 twice a day and submit the readings The web-record will be available to patient and asthma nurse to aid assessment of control during routine reviews and to the patients GP in the event of unscheduled asthma consultations
Control group paper-based monitoring Patients in the control group will be issued with a Piko meter and asked to keep a paper diary recording symptoms medication usage and FEV1 readings twice a day
Clinical care and self-management education in both groups Structured care will be provided by the practices asthma nurses trained in all aspects of the trial
Clinical care in both groups will be in accordance with the step-wise approach of the BTS-SIGN Guideline28 Patients will be reviewed monthly until control is achieved as judged by the nurse on the basis of clinical monitoring
All patients will receive a one-to-one standardised asthma education session including information on asthma asthma treatment inhaler technique monitoring and when to seek urgent assistance
B Background Despite effective treatments studies continue to demonstrate that asthma is poorly controlled12 though marked variation in the control achieved in UK general practices suggests that improvement is possible for the vast majority of patients3 Psychosocial factors such as denial of illness low outcome expectations 45 and hectic lifestyles exacerbated by limited knowledge poor self-recognition of symptoms and discordant attitudes influence patients ability to engage in self-management with resultant poor concordance with monitoring and treatment67 Interventions involving biofeedback can address these barriers by objectively demonstrating symptom severity and the impact of medication compliance8 A Cochrane review demonstrates that self-management education linked with structured care improves asthma outcomes9 Despite self-management education6 in real life compliance with traditional diary monitoring can be as low as 610 and results are often fabricated11 Electronic recording may improve compliance12 with over two-thirds of potential readings recorded over a 72-week trial13 Increasingly pervasive throughout society mobile phone technology provides a convenient portable communications medium Mobile phone-based monitoring with supporting biofeedback appears able to engage patients in their management resulting in high levels of adherence and patient acceptability1314 with many patients welcoming the innovative care15161718 Integrated within a structured care protocol this has the potential to address the barriers of poor adherence and low expectations and thereby to improve patient outcomes
Monitoring is in itself an intervention which alters behaviour The theoretical model developed by Glasziou et al describes the complementary and evolving roles of periodic professional reviews and on-going patient self-monitoring19 The monitoring of asthma with lung function andor symptoms is cited as a well-defined exemplar of this concept Our recent qualitative study suggests that people with asthma perceive a role for mobile technology in aiding transition from clinician-supported phases while control is gained to effective self-management during maintenance phases20 This approach resonates with two key health service policies the drive for technological solutions to healthcare problems21 and the importance of expert patients and self-management of long-term conditions2223 Our proposed trial tests the hypothesis that through engaging the patient in self-monitoring with timely biofeedback mobile phone technology can improve the asthma control achieved at six months compared to usual paper-based monitoring
Our multi-disciplinary team has extensive experience of tele-care delivery of primary care respiratory services patient self-management and research within general practice settings Building on extensive background work313-15171820 we offer expertise in respiratory and health services research and social science and are ideally placed to undertake this trial
Description of the mobile phone-based monitoring system see figure The system software T asthma Oxford UK can be loaded onto any web-enabled mobile phone It permits recording of symptoms medication usage and lung function Measurements are made with a Piko meter a prescribable electronic meter which records both FEV1 and peak expiratory flow PEF We have opted to record FEV1 because it is a component of the ACQ24 and the correlation between Piko and spirometry FEV1 is excellent r0982526 Data transmitted to a remote server are analysed and the latest reading returned to the mobile phone compared with the preceding weeks recordings and a prompt for using preventer medication In addition the patient and their clinician can access the record via a password-protected websiteC Design of the research A six month single-blinded randomised controlled trial
Practice recruitment Sixeight practices total list 72000 patients will be recruited from the Leicester area local to the practice of a lead co-applicant Eligible practices will have an asthma-trained nurse able to commit to the additional clinical workload
Participant recruitment Practices will use the Minimal Asthma Assessment Tool MAAT which interrogates routinely collected data on their computer database using patterns of medication usage symptom control and biometric data to identify patients 12 years and over with poorly controlled asthma3 Potential eligibility will be confirmed by inspection of manualcomputer records checking and documenting exclusion criteria other significant lung disease under specialist care for severedifficult asthma unable to communicate in English or use a mobile phone and at the request of the GP for other significant socialclinical problems The practice will invite all potentially eligible patients by post to participate
Confirmation of eligibility and baseline assessment Potential participants will attend a screening assessment normally in their practice at which eligibility will be confirmed their current asthma control assessed using the ACQ24 and suitability of their mobile phone established All patients with poorly controlled asthma defined as ACQ15 27 will be entered in the trial and a baseline assessment undertakensee summary table
Randomisation Patients will be allocated using centralised randomisation stratified by practice to mobile phone or paper-based monitoring The University of Aberdeens Health Services Research Unit will provide a 24hr telephone randomisation service
Intervention group Mobile phone based monitoring Patients in the intervention group will be issued with a Piko meter and the T software loaded onto their mobile phone They will be asked to monitor symptoms medication usage and FEV1 twice a day and submit the readings The web-record will be available to patient and asthma nurse to aid assessment of control during routine reviews and to the patients GP in the event of unscheduled asthma consultations
Control group paper-based monitoring Patients in the control group will be issued with a Piko meter and asked to keep a paper diary recording symptoms medication usage and FEV1 readings twice a day
Clinical care and self-management education in both groups Structured care will be provided by the practices asthma nurses trained in all aspects of the trial
Clinical care in both groups will be in accordance with the step-wise approach of the BTS-SIGN Guideline28 Patients will be reviewed monthly until control is achieved as judged by the nurse on the basis of clinical monitoring
All patients will receive a one-to-one standardised asthma education session including information on asthma asthma treatment inhaler technique monitoring and when to seek urgent assistance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None