Trial Outcomes & Findings for Conducting Annual Asthma Reviews Using Telehealthcare: Comparison With Standard Care (Face-to-face Consultations) (NCT NCT02545998)
NCT ID: NCT02545998
Last Updated: 2023-02-08
Results Overview
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)
COMPLETED
NA
88 participants
Up to 2 weeks after the asthma review
2023-02-08
Participant Flow
Participant milestones
| Measure |
Standard Care
Patients received a face-to-face asthma review
|
Telehealthcare
Patients received a telehealthcare asthma review consisting of a telephone consultation and an e-mail with attached PAAP and video link.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
|
Overall Study
Received the Intervention
|
33
|
42
|
|
Overall Study
COMPLETED
|
29
|
39
|
|
Overall Study
NOT COMPLETED
|
15
|
5
|
Reasons for withdrawal
| Measure |
Standard Care
Patients received a face-to-face asthma review
|
Telehealthcare
Patients received a telehealthcare asthma review consisting of a telephone consultation and an e-mail with attached PAAP and video link.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Conducting Annual Asthma Reviews Using Telehealthcare: Comparison With Standard Care (Face-to-face Consultations)
Baseline characteristics by cohort
| Measure |
Standard Care
n=33 Participants
Patients received a face-to-face asthma review
|
Telehealthcare
n=42 Participants
Patients received a telehealthcare asthma review consisting of a telephone consultation and an e-mail with attached PAAP and video link.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
38.0 years
n=5 Participants
|
38.5 years
n=7 Participants
|
38.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
29 participants
n=5 Participants
|
40 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-white
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Occupation
Employed/ full time education
|
29 participants
n=5 Participants
|
37 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Occupation
Unemployed/ retired
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Median ACT score
|
24 units on a scale
n=5 Participants
|
23 units on a scale
n=7 Participants
|
23 units on a scale
n=5 Participants
|
|
Median AQLQ score
|
5.9 units on a scale
n=5 Participants
|
6.2 units on a scale
n=7 Participants
|
6.2 units on a scale
n=5 Participants
|
|
Median length of time since last asthma review
|
32 months
n=5 Participants
|
25 months
n=7 Participants
|
30 months
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 weeks after the asthma reviewGeneral 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)
Outcome measures
| Measure |
Standard Care
n=33 Participants
Patients received a face-to-face asthma review
|
Telehealthcare
n=42 Participants
Patients received a telehealthcare asthma review consisting of a telephone consultation and an e-mail with attached PAAP and video link.
|
|---|---|---|
|
Patient Experience: Overall Patient Experience Score (General Practice Assessment Questionnaire GPAQ Score)
|
390.0 score on a scale
Interval 367.5 to 400.0
|
400.0 score on a scale
Interval 377.5 to 400.0
|
SECONDARY outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
Standard Care
n=44 Participants
Patients received a face-to-face asthma review
|
Telehealthcare
n=44 Participants
Patients received a telehealthcare asthma review consisting of a telephone consultation and an e-mail with attached PAAP and video link.
|
|---|---|---|
|
Dropout Rate
|
11 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: BaselineThe average time taken for a standard asthma review vs a telehealthcare review will be recorded at the time of the asthma review
Outcome measures
| Measure |
Standard Care
n=33 Participants
Patients received a face-to-face asthma review
|
Telehealthcare
n=42 Participants
Patients received a telehealthcare asthma review consisting of a telephone consultation and an e-mail with attached PAAP and video link.
|
|---|---|---|
|
Average Consultation Length (Time)
|
20.0 minutes
Interval 18.0 to 23.0
|
15.0 minutes
Interval 12.0 to 17.0
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsQuality 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.
Outcome measures
| Measure |
Standard Care
n=29 Participants
Patients received a face-to-face asthma review
|
Telehealthcare
n=39 Participants
Patients received a telehealthcare asthma review consisting of a telephone consultation and an e-mail with attached PAAP and video link.
|
|---|---|---|
|
Health Related Quality of Life Score (Asthma Quality of Life Questionnaire (AQLQ))
|
6.4 units on a scale
Interval 6.0 to 6.8
|
6.4 units on a scale
Interval 6.1 to 6.8
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard Care
n=29 Participants
Patients received a face-to-face asthma review
|
Telehealthcare
n=39 Participants
Patients received a telehealthcare asthma review consisting of a telephone consultation and an e-mail with attached PAAP and video link.
|
|---|---|---|
|
Asthma Control Test Score
|
24 score on a scale
Interval 23.0 to 25.0
|
23 score on a scale
Interval 22.0 to 25.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard Care
n=33 Participants
Patients received a face-to-face asthma review
|
Telehealthcare
n=42 Participants
Patients received a telehealthcare asthma review consisting of a telephone consultation and an e-mail with attached PAAP and video link.
|
|---|---|---|
|
Number of Exacerbations.
|
0 exacerbations
Interval 0.0 to 0.0
|
0 exacerbations
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard Care
n=33 Participants
Patients received a face-to-face asthma review
|
Telehealthcare
n=42 Participants
Patients received a telehealthcare asthma review consisting of a telephone consultation and an e-mail with attached PAAP and video link.
|
|---|---|---|
|
Future Preference
|
26 Participants
|
38 Participants
|
Adverse Events
Standard Care
Telehealthcare
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place