Condition category
Respiratory
Date applied
27/11/2018
Date assigned
28/12/2018
Last edited
28/12/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The burden of asthma remains a major public health issue in Malaysia, thus, steps to lighten the burden must be cost effective, multimodal and patient-centred. Asthma self-management improves asthma control, reduces attacks and hospitalisation, as well as improving quality of life. It has been shown that self-management education on asthma improves clinical outcomes and reduces healthcare costs.

An asthma action plan is part of self-management education that enable individuals with asthma to adjust their own treatments according to changes in their condition. But, in Malaysia, less than 1 in 10 people with asthma have a written asthma management plan. Pictorial representations have been shown to improve recall of medical instructions in a clinical setting and pictograms have been shown to be an effective tool, enhancing consultations and facilitating understanding. Therefore, this study aims to find out whether a supported self-management intervention incorporating the pictorial asthma action plan is feasible for adult patients with asthma.

Who can participate?
Patients aged 18 years and over with asthma who attend the participating primary healthcare clinic.

What does this study involve?
Participants will be randomly divided into two groups. Group 1 will receive usual asthma care. Group 2 will use a pictorial asthma action plan for their asthma self-management taught by a trained clinic nurse, in addition to the usual care. After enrolment, participants will receive four telephone calls by a researcher at 1, 3, 6 and 12 months. During each of the telephone calls, all participants will be asked about their asthma control, any unscheduled visits to their health care provider,changes on their medication regimes, hospitalisation and number of routine follow up appointments. Participants in Group 2 will also be asked about the use of pictorial asthma action plan tool. The telephone call may take about 10 minutes.

After the 12-month follow-up, participants in Group 2 may be invited to take part in a focus group discussion. The researcher will ask more questions about topics related to their experience in using the pictorial asthma action plan for asthma self-management. The discussion will be recorded using an audio voice recorder. The interview will take about 60 minutes.

What are the possible benefits and risks of participating?
All participants will receive usual asthma care. There may or may not be any benefits to the participants. Information obtained from this study will help improve the management of other participants with the same disease or condition. Participants will be able to contribute significantly to the development of an intervention to improve asthma self-management. The researcher will also be able to contribute to the larger body of medical knowledge in the field of asthma self-management.

There is no risk involved in this study as participants only need to answer questions, and the questions do not provoke any unpleasant feelings or any unnecessary concern. Also, the clinical assessments would not provoke any unnecessary discomfort.

Where is the study run from?
The enrolment of this study takes place at a primary healthcare clinic, Bandar Botanik Health Clinic in Klang, Selangor, Malaysia.

When is the study starting and how long is it expected to run for?
The enrolment of study participants will take place between February 2019 and March 2019 with follow-ups in April 2019, July 2019, October 2019 and January 2020..

Who is funding the study?
National Institute of Health Research, funding reference: GHR 16/136/109.

Who is the main contact?
Dr Sazlina Shariff Ghazali at +6012 232 5659

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sazlina Shariff Ghazali

ORCID ID

http://orcid.org/0000-0002-5737-7226

Contact details

Department of Family Medicine
Faculty of Medicine and Health Sciences
Universiti Putra Malaysia
Serdang
43400
Malaysia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study protocol Version 1

Study information

Scientific title

A pictorial asthma action plan to improve asthma control in adults with asthma: a pilot randomized controlled trial

Acronym

Study hypothesis

A pictorial asthma action plan tool is feasible to be used by adults with asthma in primary care setting.

Ethics approval

The Medical Research Ethics Committee, Ministry of Health, Malaysia - approval pending.

Sponsorship review will be carried out by the University of Edinburgh Academic and Clinical Central Office for Research and Development (ACCORD) who will advise as to whether additional UK ethics approvals should be sought.

Study design

Pilot randomized controlled trial, feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Asthma

Intervention

This study will be divided into two parts, which involves
1. the development of a brief pictorial asthma action plan, and
2. the assessment of acceptability, demand and practicability of a pictorial asthma action plan as an interventional tool to improve asthma control in adults with asthma.

The intervention will be conducted in an urban primary health care clinic in the district of Klang, Selangor, Malaysia. The recruitment process for eligible participants will commence in January 2019 to March 2019. An independent statistician from our Clinical Research Center will sequentially number the eligible participants and they will be allocated into two groups using a computer generated blocked randomization of four with an allocation ratio of 1:1 to create the randomization schedule. The group allocation will be concealed from the other research team involved in the recruitment and those involved in the assessments of outcomes at baseline and at every assessment time points. An independent clinic staff not part of the research team or involved in the intervention will conduct the assignment of interventions after the baseline assessment. Blinding of the participants will not be possible owing to the nature of the intervention as the participants in the intervention group will know that they will receive the pictorial asthma action plan. Blinding of assessor is possible as the assessments will be conducted by the enumerators who will not know if the participants are in the intervention or the control group. We will record any events that result in loss of blinding in order to inform the process for a full trial.

The intervention will involve a pictorial asthma action plan tool. The participants in the intervention group will be taught how to use a brief pictorial asthma action plan tool at home by trained clinic medical officers in a one-to-one encounter at the clinic.

Participants in the control group will receive the usual asthma care during the study and act as a comparison group to the intervention group. The context of usual care in this study may be either with or without follow up care.

The treatment duration is one month and the total follow up duration is 11 months for both study arms.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Asthma control is measured using ACQ mean score at baseline and 1-, 3-, 6- and -12 month post intervention.
2. Whether trial participation leads to serious negative consequences for participants.
3. Any serious concerns about the acceptability and feasibility of the trial procedures that can be rectified prior to a full trial.
4. Whether follow up data is available from at least 60% of participants at 12 months post intervention.

Secondary outcome measures

1. Unscheduled health care utilization will be measured using patient interview via telephone call and from the patient’s medical notes at baseline and 1-, 3-, 6- and -12 month post intervention.
2. Number of courses of oral steroids used will be measured using patient interview via telephone call and from the patient’s medical notes at baseline and 1-, 3-, 6- and -12 month post intervention.
3. Hospitalization will be measured using patient interview via telephone call and from the patient’s medical notes at baseline and 1-, 3-, 6- and -12 month post intervention.
4. Frequency of reliever medication use will be measured using patient interview via telephone call and from the patient’s medical notes at baseline and 1-, 3-, 6- and -12 month post intervention.
5. Frequency of controller medication use will be measured using patient interview via telephone call and from the patient’s medical notes at baseline and 1-, 3-, 6- and -12 month post intervention.
6. Frequency of utilizing the brief pictorial asthma plan will be measured using patient interview via telephone call and from the patient’s medical notes at baseline and 1-, 3-, 6- and -12 month post intervention.
7. Number of routine follow up appointments will be measured using patient interview via telephone call and from the patient’s medical notes at baseline and 1-, 3-, 6- and -12 month post intervention.

Overall trial start date

01/12/2018

Overall trial end date

31/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Known asthma diagnosed by a healthcare practitioner.
2. Taking inhaled corticosteroids.
3. Aged 18 years and older.
4. Able to understand the Malay and English languages.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant exclusion criteria

1. Known colour-blindness.
2. Severe exacerbations requiring admission.
3. Known self-reported condition prohibiting participation such as cognitive impairment, and severe communication problems

Recruitment start date

01/02/2019

Recruitment end date

30/03/2019

Locations

Countries of recruitment

Malaysia

Trial participating centre

Klinik Kesihatan Bandar Botanik Klang
Blok A, Jalan Langat, Bandar Botanic
Klang
41200
Malaysia

Sponsor information

Organisation

The University of Edinburgh, United Kingdom

Sponsor details

5 Roxburgh Street
University of Edinburgh
Edinburgh
EH8 9TA
United Kingdom

Sponsor type

University/education

Website

https://www.ed.ac.uk/usher/respire

Funders

Funder type

Government

Funder name

National Institute of Health Research, funding reference: GHR 16/136/109.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A study protocol and findings of this study will be published in academic journals and will be presented at conferences.

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/03/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes