Asthma
Conditions
Keywords
Telehealthcare
Brief 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. 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.
Interventions
OTHERTelehealthcare
Telephone consultation plus e-mail with attached PAAP and video link
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Experience: Overall Patient Experience Score (General Practice Assessment Questionnaire GPAQ Score) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Consultation Length (Time) | Baseline | The average time taken for a standard asthma review vs a telehealthcare review will be recorded at the time of the asthma review |
| Health Related Quality of Life Score (Asthma Quality of Life Questionnaire (AQLQ)) | 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. |
| Dropout Rate | 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. |
| Number of Exacerbations. | In the six months after the asthma review. | 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. |
| Future Preference | Within 2 weeks of the asthma review. | 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. |
| Asthma Control Test Score | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care Patients received a face-to-face asthma review | 33 |
| Telehealthcare Patients received a telehealthcare asthma review consisting of a telephone consultation and an e-mail with attached PAAP and video link. | 42 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 12 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Standard Care | Telehealthcare | Total |
|---|---|---|---|
| Age, Customized | 38.0 years | 38.5 years | 38.0 years |
| Median ACT score | 24 units on a scale | 23 units on a scale | 23 units on a scale |
| Median AQLQ score | 5.9 units on a scale | 6.2 units on a scale | 6.2 units on a scale |
| Median length of time since last asthma review | 32 months | 25 months | 30 months |
| Occupation Employed/ full time education | 29 participants | 37 participants | 66 participants |
| Occupation Unemployed/ retired | 4 participants | 5 participants | 9 participants |
| Race/Ethnicity, Customized Non-white | 4 participants | 2 participants | 6 participants |
| Race/Ethnicity, Customized White | 29 participants | 40 participants | 69 participants |
| Sex: Female, Male Female | 20 Participants | 24 Participants | 44 Participants |
| Sex: Female, Male Male | 13 Participants | 18 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 42 |
| serious Total, serious adverse events | 0 / 33 | 0 / 42 |
Outcome results
Primary
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)
Time frame: Up to 2 weeks after the asthma review
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Patient Experience: Overall Patient Experience Score (General Practice Assessment Questionnaire GPAQ Score) | 390.0 score on a scale |
| Telehealthcare | Patient Experience: Overall Patient Experience Score (General Practice Assessment Questionnaire GPAQ Score) | 400.0 score on a scale |
p-value: 0.51Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: 6 months after asthma review.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Asthma Control Test Score | 24 score on a scale |
| Telehealthcare | Asthma Control Test Score | 23 score on a scale |
p-value: 0.471Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Average Consultation Length (Time) | 20.0 minutes |
| Telehealthcare | Average Consultation Length (Time) | 15.0 minutes |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Dropout Rate | 11 Participants |
| Telehealthcare | Dropout Rate | 2 Participants |
p-value: 0.014Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Within 2 weeks of the asthma review.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Future Preference | 26 Participants |
| Telehealthcare | Future Preference | 38 Participants |
Secondary
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.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Health Related Quality of Life Score (Asthma Quality of Life Questionnaire (AQLQ)) | 6.4 units on a scale |
| Telehealthcare | Health Related Quality of Life Score (Asthma Quality of Life Questionnaire (AQLQ)) | 6.4 units on a scale |
p-value: 0.589Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: In the six months after the asthma review.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard Care | Number of Exacerbations. | 0 exacerbations |
| Telehealthcare | Number of Exacerbations. | 0 exacerbations |
p-value: 0.264Sign test