NCT02696174

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

February 22, 2016

Last Update Submit

March 9, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Health-seeking behavior

    Delays in seeking healthcare (days)

    Change from Baseline health seeking behavior at 6 months

  • Monthly health expenditure

    How much has been spent for monthly health expenses (in Ringgit Malaysia)

    Change from Baseline Monthly Health Expenditure at 6 months

Secondary Outcomes (4)

  • Clinical Outcome of Diabetes Mellitus

    Change from Baseline HbA1c at 6 months

  • Clinical Outcome of Hypertension

    Change from Baseline Resting Mean Blood Pressure at 6 months

  • Clinical outcome of dyslipidemia

    Change from Baseline serum cholesterol and LDL at 6 months

  • Clinical outcome of bronchial Asthma

    Change from Baseline spirometry levels at 6 months

Study Arms (2)

Health Microinsurance Scheme

EXPERIMENTAL

Households owning the HMI package, entitling them to visit and receive treatment from the selected primary care clinic

Other: HMI

Out-Of-Pocket

NO INTERVENTION

Households who visit the selected primary care clinic, but pay by Out-Of-Pocket

Interventions

HMIOTHER

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

Also known as: Health Microinsurance Scheme
Health Microinsurance Scheme

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Dr Murallitharan Munisamy

    College of Public Health Sciences Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Murallitharan Munisamy

CONTACT

Dr Tharini Thanapalan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Research Fellow

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 2, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

March 10, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

Available IPD Datasets

Study Protocol Access
Informed Consent Form Access
Questionnaires Access