- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02696174
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
Unknown
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
114
Phase
- 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.
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Households were located in the study area
- Method of payment to clinic is by out-of-pocket
- This is household's regular choice of primary care provider.
- Patient has been seen in the clinic since at least the past two years i.e from before Jan 1, 2014
Exclusion Criteria:
- Households had members who died in the year 2014.
- Households had members who were away from this place of residence for work/transferred for more than 1 month in 2014.
- Households had members who had regular follow-up in public facilities for chronic disease.
- 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)
- 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 |
Intervention / Treatment |
|---|---|
|
Experimental: Health Microinsurance Scheme
Households owning the HMI package, entitling them to visit and receive treatment from the selected primary care clinic
|
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:
|
|
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
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
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
Investigators
- 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
April 1, 2016
Primary Completion (Anticipated)
September 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
February 22, 2016
First Submitted That Met QC Criteria
February 25, 2016
First Posted (Estimate)
March 2, 2016
Study Record Updates
Last Update Posted (Estimate)
March 10, 2016
Last Update Submitted That Met QC Criteria
March 9, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- NMRR 29311
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Study Data/Documents
-
Study Protocol
Information comments: Username: HMI Password: insurance Total protocol FILE named protocol.pdf
-
Informed Consent Form
Information comments: Username: HMI Password: insurance Patient Information Sheet and Consent forms in English and Bahasa Malaysia
-
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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