Condition category
Not Applicable
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Many people living in Malaysia are unable to access adequate healthcare. It is a growing problem, especially for families on a low income with children or a member suffering from a long-term (chronic) disease, such as diabetes or asthma. Despite healthcare services being available almost free of charge from the government, many citizens are still unable to be seen because of long waiting times and lack of specialized and personalized care. As a result of this, private healthcare clinics in which a patient needs to pay for healthcare (out-of-pocket financing, OOP) are becoming more common. This can be very difficult for those on a low income, as they may not be able to afford to get treatment as often as they need if they are suffering from a chronic disease. Microinsurance schemes are a type of financial protection for people on a low income, in which health insurance to low-income households in developing countries. The aim of this study is to find out whether a Health Microinsurance Scheme (HMI) at a private healthcare clinic is an effective way to encourage Malaysians to seek healthcare more often as needed.

Who can participate?
Members of households in Kuala Lumpur (Malaysia) that pay for their own medical care and have been seen in a participating private healthcare clinic within the last two years.

What does the study involve?
Fifty seven households who usually attend each of the two participating private healthcare clinics are randomly selected. Those who attend one clinic are given full access to the Health Microinsurance Scheme (HMI) for free for six months. This allows them to visit the healthcare clinic and use their services as much as they like within the six months. Those who attend the other clinic continue to seek treatment in the normal way, paying for the healthcare services they used (out-of-pocket). At the start of the study and then again after six months, the head of each household completes a number of questionnaires in order to assess how much they have used healthcare services in the last six months.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
1. Klinik Suria (Malaysia)
2. Klinik Mediprima (Malaysia)

When is the study starting and how long is it expected to run for?
December 2015 to December 2016

Who is funding the study?
Chulalongkorn University (Thailand)

Who is the main contact?
Dr Murallitharan Munisamy

Trial website

Contact information



Primary contact

Dr Murallitharan Munisamy


Contact details

College of Public Health Sciences Institute
Building 3 (10th – 11th floor)
Chulalongkorn Soi 62
Phyathai Road
+66 2 218 8193

Additional identifiers

EudraCT number number

Protocol/serial number

NMRR 29311

Study information

Scientific title

Effectiveness of a health microinsurance scheme in improving health equity and clinical outcomes for private primary care in Kuala Lumpur, Malaysia


Study hypothesis

A Health Microinsurance Scheme (HMI) is more effective compared to Out-of-Pocket (OOP) payments in improving health equity and clinical outcomes for private primary care clinics in Kuala Lumpur, Malaysia.

Ethics approval

Malaysian Research Ethics Committee, Ministry of Health Malaysia, 04/03/2016, ref: NMRR-16-172-29311(IIR)

Study design

Multi-centre quasi-experimental two arm pre-post intervention trial

Primary study design


Secondary study design

Randomised parallel trial

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Financing primary healthcare


From each clinic, the list of patients who pay Out-Of-Pocket for consultation/treatment (current practice in Private Primary Care clinics in Malaysia) are compiled by family. These are patients who are already regular clients of these clinics and no outside populations are being recruited. Fifty seven households are then randomly selected from each clinic. Once the heads of the households provide informed consent, all participants answer a detailed questionnaire to capture their health-seeking behaviour, monthly health expenditure and through patient records at the clinic, capture changes in clinical outcomes for those with chronic disease. Participants attending one clinic take part in the Health Microinsurance Scheme (HMI) and those attending the other take part in a control arm.

Health Microinsurance Scheme (HMI) - Participants are provided with a fully-paid Health Microinsurance Scheme for 6 months. This scheme covers all their treatment and consultation costs, including drugs at the experimental clinic site. Participants are allowed to visit and receive all treatment and services at the clinic as and when they require it.

Control - Patients visiting the control clinic are also free to visit and receive all treatment and services at the clinic as and when they require it, but will pay for it as per usual prices without any change.

After six months, the questionnaire completed at baseline is repeated for all participants.

Intervention type



Drug names

Primary outcome measure

Health-seeking behaviour is measured as the delay in seeking care in days at baseline and 6 months.

Secondary outcome measures

1. Monthly household health expenditure is measured using the self-estimated in Ringgit Malaysia (RM) at baseline and 6 months
2. Quantifiable validated results for chronic diseases (such as HbA1c for DM, mean resting blood pressure for hypertension, Total serum cholesterol and LDL for dyslipidemia, spirometry for Bronchial Asthma) are recorded at baseline and 6 months

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Households were located in the study area
2. Method of payment to clinic is by out-of-pocket
3. Members of the household’s regular choice of primary care provider
4. Patient has been seen in the clinic within the past two years
provided with a fully-paid Health Microinsurance Scheme for 6 months. This scheme covers all their treatment and consultation costs, including drugs at the experimental clinic site. Participants are allowed to visit and receive all treatment and services at the clinic as and when they require it.

Participant type


Age group




Target number of participants

There will be 57 households in each arm with 114 households to be included in the two arms. With expected a minimum of 3 people per household, it is estimated that there will be 342 participants in the trial.

Participant exclusion criteria

1. Households with members who died in the year 2014
2. Households with members who were away from this place of residence for work/transferred for more than 1 month in 2014
3. Households with members who had regular follow-up in public facilities for chronic disease
4. Households with members who have switched methods of payment in the last year (e.g. newly bought insurance or retired and lost health benefits so paying OOP)
5. Patients who refuse consent

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Klinik Suria
Jalan Ipoh
Kuala Lumpur

Trial participating centre

Klinik Mediprima
Jalan Ipoh
Kuala Lumpur

Sponsor information


Chulalongkorn University

Sponsor details

College of Public Health Sciences
Chulalongkorn University Institute Building 2-3
Soi Chulalongkorn 62
+66 2218 8193

Sponsor type




Funder type


Funder name

Chulalongkorn University

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype




Results and Publications

Publication and dissemination plan

Planned publication of at least four papers in a peer reviewed journal involving:
1. Baseline results of trial - economics
2. Total results of trial -economics
3. Total results of trial - clinical outcomes
4. Policy paper

Intention to publish date


Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/03/2016: Ethics approval information added.