NCT02545998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

February 8, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

May 21, 2015

Results QC Date

November 11, 2021

Last Update Submit

February 6, 2023

Conditions

Keywords

Telehealthcare

Outcome Measures

Primary Outcomes (1)

  • 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)

    Up to 2 weeks after the asthma review

Secondary Outcomes (6)

  • Dropout Rate

    Baseline

  • Average Consultation Length (Time)

    Baseline

  • Health Related Quality of Life Score (Asthma Quality of Life Questionnaire (AQLQ))

    Baseline and 6 months

  • Asthma Control Test Score

    6 months after asthma review.

  • Number of Exacerbations.

    In the six months after the asthma review.

  • +1 more secondary outcomes

Study Arms (2)

Standard care

NO INTERVENTION

Patients will receive a face-to-face asthma review

Telehealthcare

ACTIVE COMPARATOR

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

Other: Telehealthcare

Interventions

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

Telehealthcare

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balham Park Surgery

London, SW17 7AW, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Dr Sarah Glynne
Organization
Oxshott Medical Practice

Study Officials

  • Sarah Glynne, MRCP MRCGP

    Balham Park Surgery, Wandsworth CCG

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2015

First Posted

September 10, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 8, 2023

Results First Posted

February 8, 2023

Record last verified: 2023-02

Locations