| CTRI Number |
CTRI/2023/01/049350 [Registered on: 31/01/2023] Trial Registered Prospectively |
| Last Modified On: |
30/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing household expenses due to healthcare seeking in India |
|
Scientific Title of Study
|
Healthcare seeking, associated costs and its consequences on household economy in India: an observational cohort study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarmila Mazumder |
| Designation |
Senior Deputy Director and Senior Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
45, Kalu Sarai, New Delhi
South
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
sarmila.mazumder@sas.org.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarmila Mazumder |
| Designation |
Senior Deputy Director and Senior Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
45, Kalu Sarai, New Delhi
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
sarmila.mazumder@sas.org.in |
|
Details of Contact Person
Public Query
|
| Name |
Sarmila Mazumder |
| Designation |
Senior Deputy Director and Senior Scientist |
| Affiliation |
Centre for Health Research and Development, Society for Applied Studies |
| Address |
45, Kalu Sarai, New Delhi
DELHI
110016
India |
| Phone |
011-46043751-55 |
| Fax |
011-46043756 |
| Email |
sarmila.mazumder@sas.org.in |
|
|
Source of Monetary or Material Support
|
| Research Council of Norway |
|
|
Primary Sponsor
|
| Name |
Centre for Health Research and Development Society for Applied Studies |
| Address |
45, Kalu Sarai, New Delhi-110016 |
| Type of Sponsor |
Other [Research Organization] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sarmila Mazumder |
Centre for Health Research and Development, Society for Applied Studies, |
Village Jatola, District Palwal, Tatarpur
Faridabad
HARYANA |
011-46043751-55
011-46043756
sarmila.mazumder@sas.org.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Review Committee, Centre for Health Research and Development, Society for Applied Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z597||Insufficient social insurance andwelfare support, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
We will enroll households in Palwal district, Haryana who meet the inclusion criteria: do not intent to move out of the study area and consent to participate. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The proportion of households experiencing Catastrophic Healthcare Expenditure (CHE) due to healthcare seeking costs.
2. The proportion of households which face impoverishment due to healthcare seeking costs
Secondary outcomes
1. Mean direct medical, direct non-medical and indirect costs due to healthcare seeking at household level and its distribution by age group and contextually relevant sociodemographic factors.
2. Inequity in healthcare expenditure, CHE and impoverishment based on contextually relevant sociodemographic variables, care seeking pattern and specific health condition groups measured by concentration index and concentration curves.
3. Inequity in care seeking for different healthcare conditions across levels of household consumption measured by concentration index and concentration curves.
4. Choices made by the study households during healthcare seeking and its variation
|
At any time point during one year post enrolment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stated along with the Primary outcomes |
At any time point during one year post enrolment |
|
|
Target Sample Size
|
Total Sample Size="3000"
Sample Size from India="3000"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will be a prospective observational
cohort study that aims to assess healthcare expenses and its consequences on
household economy. We will estimate the
proportion of households experiencing Catastrophic Healthcare Expenditure (CHE)
and impoverishment due to healthcare seeking costs. The factors associated with
OOPE, CHE and impoverishment will also be assessed. We will also explore inequity
in health care seeking, CHE and
impoverishment across levels of household consumption and contextually relevant
socio demographic factors. We will follow a prospective observational cohort of
three thousand households with monthly follow-up for 1-year in Palwal, Haryana.
We will enroll households from the Demographic Surveillance system (DSS)
established in Palwal, Haryana. |