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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

88 participants

Primary outcome timeframe

Up to 2 weeks after the asthma review

Results posted on

2023-02-08

Participant Flow

Participant milestones

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

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

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 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)

Outcome measures

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: 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.

Outcome measures

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: Baseline

The average time taken for a standard asthma review vs a telehealthcare review will be recorded at the time of the asthma review

Outcome measures

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 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.

Outcome measures

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

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

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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Telehealthcare

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Sarah Glynne

Oxshott Medical Practice

Phone: 01372 844000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place