- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02545998
Conducting Annual Asthma Reviews Using Telehealthcare: Comparison With Standard Care (Face-to-face Consultations)
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 Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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London, United Kingdom, SW17 7AW
- Balham Park Surgery
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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NO_INTERVENTION: Standard care
Patients will receive a face-to-face asthma review
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ACTIVE_COMPARATOR: Telehealthcare
Patients will receive a telephone consultation and e-mail with attached PAAP and video link
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Telephone consultation plus e-mail with attached PAAP and video link
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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) |
Up to 2 weeks after the asthma review
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dropout Rate
Time Frame: Baseline
|
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.
|
Baseline
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Average Consultation Length (Time)
Time Frame: Baseline
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The average time taken for a standard asthma review vs a telehealthcare review will be recorded at the time of the asthma review
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Baseline
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Health Related Quality of Life Score (Asthma Quality of Life Questionnaire (AQLQ))
Time Frame: Baseline and 6 months
|
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. |
Baseline and 6 months
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Asthma Control Test Score
Time Frame: 6 months after asthma review.
|
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. |
6 months after asthma review.
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|
Number of Exacerbations.
Time Frame: In the six months after the asthma review.
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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.
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In the six months after the asthma review.
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Future Preference
Time Frame: Within 2 weeks of the asthma review.
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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. |
Within 2 weeks of the asthma review.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15IC2535
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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