Health Care Quality, Access, and EvaluationHMINCT02696174
Effectiveness of A Health Microinsurance Scheme for Private Primary Care in Malaysia
A study testing HMI in people with Health Care Quality, Access, and Evaluation and Insurance, Health, run by Chulalongkorn University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Care Quality, Access, and Evaluation, Insurance, Health
- What is being tested?
- HMI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- HMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMIOther
Also called Health Microinsurance Scheme
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
| Study group | Role | What they receive |
|---|---|---|
| Health Microinsurance Scheme | Experimental | Households owning the HMI package, entitling them to visit and receive treatment from the selected primary care clinic Receives: Other: HMI |
| Out-Of-Pocket | No intervention | Households who visit the selected primary care clinic, but pay by Out-Of-Pocket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-seeking behavior
Delays in seeking healthcare (days)
Measured: Change from Baseline health seeking behavior at 6 months
Monthly health expenditure
How much has been spent for monthly health expenses (in Ringgit Malaysia)
Measured: Change from Baseline Monthly Health Expenditure at 6 months
Secondary outcomes (4)
Clinical Outcome of Diabetes Mellitus
Measurement of HbA1c
Measured: Change from Baseline HbA1c at 6 months
Clinical Outcome of Hypertension
Resting mean blood pressure
Measured: Change from Baseline Resting Mean Blood Pressure at 6 months
Clinical outcome of dyslipidemia
Total serum cholesterol and LDL
Measured: Change from Baseline serum cholesterol and LDL at 6 months
Clinical outcome of bronchial Asthma
Spirometry levels
Measured: Change from Baseline spirometry levels at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Care Quality, Access, and EvaluationStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muralllitharan Munisamy, Chulalongkorn University
- Investigators
- Dr Murallitharan Munisamy, Principal investigator, College of Public Health Sciences Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696174
- Sponsor's protocol ID
- NMRR 29311
- Acronym
- HMI
- Status last verified
- Mar 2016
- First submitted
- 22 Feb 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of A Health Microinsurance Scheme in Improving Health Equity and Clinical Outcomes for Private Primary Care in Kuala Lumpur, Malaysia
- ClinicalTrials.gov ID
- NCT02696174
- Acronym / sponsor ID
- HMI / NMRR 29311
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Microinsurance Scheme | Experimental | Other: HMIHouseholds owning the HMI package, entitling them to visit and receive treatment from the selected primary care clinic |
| Out-Of-Pocket | No intervention | –Households who visit the selected primary care clinic, but pay by Out-Of-Pocket |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMIAlso: Health Microinsurance SchemeA 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 | Health Microinsurance Scheme |
Primary outcome
Health-seeking behavior
Time frame: Change from Baseline health seeking behavior at 6 months
Delays in seeking healthcare (days)
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)
4 secondary outcomes
Clinical Outcome of Diabetes Mellitus
Time frame: Change from Baseline HbA1c at 6 months
Clinical Outcome of Hypertension
Time frame: 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
Clinical outcome of bronchial Asthma
Time frame: Change from Baseline spirometry levels at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Individual participant dataSharing planned: Yes
Related trials for Health Care Quality, Access, and Evaluation
Active, not recruiting
Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers
Dementia, Dementia, Vascular
Enrolling by invitationObservational study
ESCAPE10: Epidemiology, Risk Factors, and Outcomes of Severe Community-acquired Pneumonia in Elderly Patients Acquired Pneumonia in Elderly Patients
Severe Community-Acquired Pneumonia (sCAP), Elderly Infection
Recruiting
Artificial Intelligence Satisfaction in Professionals and Patients
General Health Status
Active, not recruiting
Proactive Telemedicine to Improve Healthcare Access and Prevention in Rural Primary Care (PTM)
Primary Health Care, Telemedicine
Not yet recruiting
ICP for Patients With Complex Care Needs in Ontario and Alberta, Canada
Health Care Quality, Access, and Evaluation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Murallitharan Munisamy principal investigator
College of Public Health Sciences Chulalongkorn University
Questions about this trial
What is this clinical trial studying?
A study testing HMI in people with Health Care Quality, Access, and Evaluation and Insurance, Health, run by Chulalongkorn University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Murallitharan Munisamy (+60123173575, murallimd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-seeking behavior (time frame: Change from Baseline health seeking behavior at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.