Effectiveness of A Health Microinsurance Scheme for Private Primary Care in Malaysia (HMI)

March 9, 2016 updated by: Muralllitharan Munisamy, Chulalongkorn University

Effectiveness of A Health Microinsurance Scheme in Improving Health Equity and Clinical Outcomes for Private Primary Care in Kuala Lumpur, Malaysia

This is the Phase 3 of a 3 phase study to determine the feasibility, acceptability and effectiveness of a health microinsurance scheme in improving health equity and clinical outcomes for private primary care (PPC) in Kuala Lumpur, Malaysia. This two-arm, pre-post, quasi-experimental trial consisted of utilizing a HMI scheme (experimental clinic) and normal OOP payments (control clinic) for 6 months. The HMI scheme enabled subscribed households to access a defined benefit package at a selected PPC for treatment and follow-up.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be a quasi-experimental study designed to determine the effectiveness of a community health microinsurance scheme (HMI) in private primary care clinics in Malaysia via a pre-post study of an experimental and control clinic. A proposed HMI scheme, whose price and benefit package have been defined through the earlier Phases 1 and 2, will be accessible to subscribed households at the experimental clinic, while the control clinic has subscribed patients paying as per normal practise, which is by Out-Of-Pocket payment. The HMI scheme enabled subscribers to visit the selected clinic chosen for any form of primary care diagnosis, treatment and follow-up. Both the clinics are located in the Jalan Ipoh area, a suburb of Kuala Lumpur, and have common sociodemographic characteristics. A pre-intervention questionnaire will aim to capture health seeking behaviour, delay in seeking medical care, monthly health expenditure and improvements in clinical outcome (assessed by clinical test results). After six months, a post-intervention questionnaire is administered again to the respondents which then allows assessment of the outcome variables.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Households were located in the study area
  2. Method of payment to clinic is by out-of-pocket
  3. This is household's regular choice of primary care provider.
  4. Patient has been seen in the clinic since at least the past two years i.e from before Jan 1, 2014

Exclusion Criteria:

  1. Households had members who died in the year 2014.
  2. Households had members who were away from this place of residence for work/transferred for more than 1 month in 2014.
  3. Households had 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Health Microinsurance Scheme
Households owning the HMI package, entitling them to visit and receive treatment from the selected primary care clinic
Other: HMI
A defined priced package of primary care services, including investigation and treatment such as procedures and medication, available at a selected clinic for 6 months
Other Names:
  • Health Microinsurance Scheme
No Intervention: Out-Of-Pocket
Households who visit the selected primary care clinic, but pay by Out-Of-Pocket

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Health-seeking behavior
Time Frame: Change from Baseline health seeking behavior at 6 months
Delays in seeking healthcare (days)
Change from Baseline health seeking behavior at 6 months
Monthly health expenditure
Time Frame: Change from Baseline Monthly Health Expenditure at 6 months
How much has been spent for monthly health expenses (in Ringgit Malaysia)
Change from Baseline Monthly Health Expenditure at 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Outcome of Diabetes Mellitus
Time Frame: Change from Baseline HbA1c at 6 months
Measurement of HbA1c
Change from Baseline HbA1c at 6 months
Clinical Outcome of Hypertension
Time Frame: Change from Baseline Resting Mean Blood Pressure at 6 months
Resting mean blood pressure
Change from Baseline Resting Mean Blood Pressure at 6 months
Clinical outcome of dyslipidemia
Time Frame: Change from Baseline serum cholesterol and LDL at 6 months
Total serum cholesterol and LDL
Change from Baseline serum cholesterol and LDL at 6 months
Clinical outcome of bronchial Asthma
Time Frame: Change from Baseline spirometry levels at 6 months
Spirometry levels
Change from Baseline spirometry levels at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chulalongkorn University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr Murallitharan Munisamy, College of Public Health Sciences Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NMRR 29311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Study Data/Documents

  1. Study Protocol
    Information comments: Username: HMI Password: insurance Total protocol FILE named protocol.pdf
  2. Informed Consent Form
    Information comments: Username: HMI Password: insurance Patient Information Sheet and Consent forms in English and Bahasa Malaysia
  3. Questionnaires
    Information comments: Username: HMI Password: insurance All questionnaires (English) uploaded

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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