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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02696174
Other study ID # NMRR 29311
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 22, 2016
Last updated March 9, 2016
Start date April 2016
Est. completion date December 2016

Study information

Verified date March 2016
Source Chulalongkorn University
Contact Dr Murallitharan Munisamy
Phone +60123173575
Email murallimd@gmail.com
Is FDA regulated No
Health authority Malaysia: National Medical Research Register
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 114
Est. completion date December 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chulalongkorn University

Outcome

Type Measure Description Time frame Safety issue
Primary Health-seeking behavior Delays in seeking healthcare (days) Change from Baseline health seeking behavior at 6 months No
Primary Monthly health expenditure How much has been spent for monthly health expenses (in Ringgit Malaysia) Change from Baseline Monthly Health Expenditure at 6 months No
Secondary Clinical Outcome of Diabetes Mellitus Measurement of HbA1c Change from Baseline HbA1c at 6 months No
Secondary Clinical Outcome of Hypertension Resting mean blood pressure Change from Baseline Resting Mean Blood Pressure at 6 months No
Secondary Clinical outcome of dyslipidemia Total serum cholesterol and LDL Change from Baseline serum cholesterol and LDL at 6 months No
Secondary Clinical outcome of bronchial Asthma Spirometry levels Change from Baseline spirometry levels at 6 months No
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