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NCT Number: 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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Balham Park Surgery

London, SW17 7AW, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telehealthcare

Other

Telephone consultation plus e-mail with attached PAAP and video link

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. Average Consultation Length (Time)

    Time frame: Baseline

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

  3. 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.

  4. 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.

  5. Number of Exacerbations.

    Time frame: 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.

  6. Future Preference

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 10, 2015
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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