AsthmaNCT02545998
Conducting Annual Asthma Reviews Using Telehealthcare: Comparison With Standard Care (Face-to-face Consultations)
A study testing Telehealthcare in people with Asthma, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The National Report of Asthma Deaths published in 2014 highlighted significant deficiencies in both primary and secondary care resulting in one of the highest mortality rates in Europe. A key recommendation in the report is the provision of an annual asthma review in primary care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Telehealthcare
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Jun 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 and over, registered at Balham Park Surgery
- Patients diagnosed with asthma (patients on the asthma register)
- Patients with well-controlled asthma (ACT score 20 and over; no out of hours/ A\&E attendances/ PO steroids/ hospital admissions since the last asthma review in primary care)
Who cannot join
- Patients aged less than 18
- Patients with poorly controlled asthma (ACT score 19 or less; out of hours/ A\&E attendance/ hospital admission/ PO steroids since last asthma review in primary care)
- Patients with a mental health diagnosis
- Patients without an up to date contact telephone number or with communication difficulties that would prevent or restrict their use of the technology.
Trial locations and contacts
1 site in 1 country.
About this study
The National Report of Asthma Deaths published in 2014 highlighted significant deficiencies in both primary and secondary care resulting in one of the highest mortality rates in Europe. A key recommendation in the report is the provision of an annual asthma review in primary care.
Telehealthcare is an alternative means of service delivery incorporating the use of telephone and e-mail consultations which may improve access and quality of patient care. There is scant data on the role of teleheathcare in asthma care.
Read more
This is a single-centre, primary care-based, randomized controlled trial to evaluate the use of telehealthcare to conduct the annual asthma review for adult patients with well-controlled asthma. This will be compared with standard care (face-to-face consultations).
Telehealthcare will consist of a telephone consultation followed by an e-mail with an attached personalised asthma action plan and a link to a video demonstrating inhaler technique.
Standard care will involve a face-to-face consultation in primary care. The two patient groups will be compared prospectively to determine whether there is a difference in the quality of care evaluated in terms of the patient experience/ satisfaction, health-related quality of life, asthma control and frequency of asthma exacerbations over a 6 month period after the asthma review.
The data will be presented in the form of frequency tables, bar charts and pie charts. Non-parametric tests will be applied to determine whether there is a significant difference in the quality of care received.
- Conditions
- Asthma
- Being tested
- Telehealthcare
- Keywords
- Telehealthcare
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelehealthcareOther
Telephone consultation plus e-mail with attached PAAP and video link
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Patients will receive a face-to-face asthma review |
| Telehealthcare | Active comparator | Patients will receive a telephone consultation and e-mail with attached PAAP and video link Receives: Other: Telehealthcare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Experience: Overall Patient Experience Score (General Practice Assessment Questionnaire GPAQ Score)
General Practice Assessment Questionnaire (GPAQ) is a widely used questionnaire to assess the patient experience of general practice in the UK. It is designed to measure satisfaction across four domains: communication (8 items), confidence (3 items), access to care (2 items) and overall satisfaction (2 items). Patients rate their experience by selecting not of usually 5 responses (1= very good to 5= very poor). Response items were linearly rescaled to a 0-100 range (100 = most favourable response). 'Does not apply' responses were excluded from the analysis.
This yielded four median domain scores for each patient (range 0-100 per domain).
An overall patient experience score was calculated for each patient by adding the four domain scores together to give a total score out of 400 (range 0-400).
The median overall patient experience score (+/- interquartile range) was calculated for each group and the scores were compared (tele healthcare vs control)
Measured: Up to 2 weeks after the asthma review
Secondary outcomes (6)
Dropout Rate
The dropout rate is the number of patients that failed to attend for an asthma review ('Did not attend', lost to follow up, or withdrew consent) in each patient group.
Measured: Baseline
Average Consultation Length (Time)
The average time taken for a standard asthma review vs a telehealthcare review will be recorded at the time of the asthma review
Measured: Baseline
Health Related Quality of Life Score (Asthma Quality of Life Questionnaire (AQLQ))
Quality of life will be assessed using the Asthma Quality of Life Questionnaire (AQLQ) in each group at the start of the study (before the asthma review) and 6 months after the asthma review.
Asthma Quality of Life Questionnaire (AQLQ) is a valid, reliable questionnaire that measures the "functional problems" (physical, emotional, social and occupational) that are most troublesome to adults aged 17-70 years with asthma. For the purpose of this study, a 15-item mini-AQLQ was used, with scores ranging from 1 (severely impaired) to 7 (not impaired at all).
The 6 month AQLQ score is presented in each group. The p value compares the change in AQLQ score from baseline to 6 months between the two groups.
Measured: Baseline and 6 months
Asthma Control Test Score
Assessment of asthma control using validated questionnaire at baseline (before the asthma review) and 6 months after the asthma review.
The ACT score at 6 months is presented. The p value compares the change in ACT score from baseline to 6 months, in each group.
Asthma Control Test (ACT) is a simple, five-item, validated questionnaire that is designed to identify patients (>12 years old) with poorly controlled asthma. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.
Measured: 6 months after asthma review.
Number of Exacerbations.
Number of exacerbations (unscheduled asthma consultations in primary care, courses of systemic steroids, out of hour attendances, hospital admissions) in the six months after the asthma review in each group.
Measured: In the six months after the asthma review.
Future Preference
After the asthma review, patients were asked whether they would prefer a tele healthcare asthma review in future.
Percentage of patients that expressed preference for THC review is presented.
Measured: Within 2 weeks of the asthma review.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionJun 2016
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.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Glynne, MRCP MRCGP, Principal investigator, Balham Park Surgery, Wandsworth CCG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545998
- Sponsor's protocol ID
- 15IC2535
- Status last verified
- Feb 2023
- First submitted
- 21 May 2015
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conducting Annual Asthma Reviews Using Telehealthcare: Comparison With Standard Care (Face-to-face Consultations)
- ClinicalTrials.gov ID
- NCT02545998
- Acronym / sponsor ID
- 15IC2535
- Conditions
- Asthma
- Keywords
- Telehealthcare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Posted 8 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The National Report of Asthma Deaths published in 2014 highlighted significant deficiencies in both primary and secondary care resulting in one of the highest mortality rates in Europe. A key recommendation in the report is the provision of an annual asthma review in primary care.
Telehealthcare is an alternative means of service delivery incorporating the use of telephone and e-mail consultations which may improve access and quality of patient care. There is scant data on the role of teleheathcare in asthma care.
This is a single-centre, primary care-based, randomized controlled trial to evaluate the use of telehealthcare to conduct the annual asthma review for adult patients with well-controlled asthma. This will be compared with standard care (face-to-face consultations).
Telehealthcare will consist of a telephone consultation followed by an e-mail with an attached personalised asthma action plan and a link to a video demonstrating inhaler technique.
Standard care will involve a face-to-face consultation in primary care. The two patient groups will be compared prospectively to determine whether there is a difference in the quality of care evaluated in terms of the patient experience/ satisfaction, health-related quality of life, asthma control and frequency of asthma exacerbations over a 6 month period after the asthma review.
The data will be presented in the form of frequency tables, bar charts and pie charts. Non-parametric tests will be applied to determine whether there is a significant difference in the quality of care received.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Patients will receive a face-to-face asthma review |
| Telehealthcare | Active comparator | Other: TelehealthcarePatients will receive a telephone consultation and e-mail with attached PAAP and video link |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 and over, registered at Balham Park Surgery
- Patients diagnosed with asthma (patients on the asthma register)
- Patients with well-controlled asthma (ACT score 20 and over; no out of hours/ A\&E attendances/ PO steroids/ hospital admissions since the last asthma review in primary care)
Key exclusion criteria (4 listed)
- Patients aged less than 18
- Patients with poorly controlled asthma (ACT score 19 or less; out of hours/ A\&E attendance/ hospital admission/ PO steroids since last asthma review in primary care)
- Patients with a mental health diagnosis
- Patients without an up to date contact telephone number or with communication difficulties that would prevent or restrict their use of the technology.
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 |
|---|---|---|
| TelehealthcareTelephone consultation plus e-mail with attached PAAP and video link | Other | Telehealthcare |
Primary outcome
Patient Experience: Overall Patient Experience Score (General Practice Assessment Questionnaire GPAQ Score)
Time frame: Up to 2 weeks after the asthma review
General Practice Assessment Questionnaire (GPAQ) is a widely used questionnaire to assess the patient experience of general practice in the UK. It is designed to measure satisfaction across four domains: communication (8 items), confidence (3 items), access to care (2 items) and overall satisfaction (2 items). Patients rate their experience by selecting not of usually 5 responses (1= very good to 5= very poor). Response items were linearly rescaled to a 0-100 range (100 = most favourable response). 'Does not apply' responses were excluded from the analysis. This yielded four median domain scores for each patient (range 0-100 per domain). An overall patient experience score was calculated for each patient by adding the four domain scores together to give a total score out of 400 (range 0-400). The median overall patient experience score (+/- interquartile range) was calculated for each group and the scores were compared (tele healthcare vs control)
6 secondary outcomes
Dropout Rate
Time frame: Baseline
Average Consultation Length (Time)
Time frame: Baseline
Health Related Quality of Life Score (Asthma Quality of Life Questionnaire (AQLQ))
Time frame: Baseline and 6 months
Asthma Control Test Score
Time frame: 6 months after asthma review.
Number of Exacerbations.
Time frame: In the six months after the asthma review.
Future Preference
Time frame: Within 2 weeks of the asthma review.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Sarah Glynne, MRCP MRCGP principal investigator
Balham Park Surgery, Wandsworth CCG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealthcare 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 3 inclusion and 4 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 8 Feb 2023. 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 8 Feb 2023). 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?
Patient Experience: Overall Patient Experience Score (General Practice Assessment Questionnaire GPAQ Score) (time frame: Up to 2 weeks after the asthma review). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2023.