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Conducting Annual Asthma Reviews Using Telehealthcare: Comparison With Standard Care (Face-to-face Consultations)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Telehealthcare
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring Telehealthcare

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Balham Park Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard care

Telehealthcare

Arm Description

Patients will receive a face-to-face asthma review

Patients will receive a telephone consultation and e-mail with attached PAAP and video link

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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
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.
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.
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.
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.

Full Information

First Posted
May 21, 2015
Last Updated
February 6, 2023
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT02545998
Brief Title
Conducting Annual Asthma Reviews Using Telehealthcare: Comparison With Standard Care (Face-to-face Consultations)
Official Title
Conducting Annual Asthma Reviews Using Telehealthcare: Comparison With Standard Care (Face-to-face Consultations)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Telehealthcare

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Patients will receive a face-to-face asthma review
Arm Title
Telehealthcare
Arm Type
Active Comparator
Arm Description
Patients will receive a telephone consultation and e-mail with attached PAAP and video link
Intervention Type
Other
Intervention Name(s)
Telehealthcare
Intervention Description
Telephone consultation plus e-mail with attached PAAP and video link
Primary Outcome Measure Information:
Title
Patient Experience: Overall Patient Experience Score (General Practice Assessment Questionnaire GPAQ Score)
Description
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
Secondary Outcome Measure Information:
Title
Dropout Rate
Description
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
Title
Average Consultation Length (Time)
Description
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
Title
Health Related Quality of Life Score (Asthma Quality of Life Questionnaire (AQLQ))
Description
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
Title
Asthma Control Test Score
Description
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.
Title
Number of Exacerbations.
Description
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.
Title
Future Preference
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Glynne, MRCP MRCGP
Organizational Affiliation
Balham Park Surgery, Wandsworth CCG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Balham Park Surgery
City
London
ZIP/Postal Code
SW17 7AW
Country
United Kingdom

12. IPD Sharing Statement

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Conducting Annual Asthma Reviews Using Telehealthcare: Comparison With Standard Care (Face-to-face Consultations)

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