Condition category
Not Applicable
Date applied
15/10/2010
Date assigned
22/10/2010
Last edited
22/10/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Sapna Desai

ORCID ID

Contact details

SEWA Health
Chanda Niwas
Nr. Hariharanand Ashram
Ahmedabad
380006
India
sapna.i.desai@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Experimental cluster randomised study to assess how a community health education intervention affects the health seeking behaviour of women insured by VimoSEWA and non-insured women

Acronym

VSAS (VimoSEWA Arogya Sanshodan)

Study hypothesis

A significant proportion of health insurance hospitalisation claims by the poor are for primary illnesses - waterborne illness and fever/malaria - and hysterectomy (hereafter referred to as commonly claimed for conditions) which may not require hospitalisation. We assess if a targeted health education intervention delivered by community health workers impacts on hospitalisation claim patterns, health seeking behaviour and expenditure for commonly claimed for conditions amongst insured and uninsured women and their families.

Ethics approval

Executive Committee of the SEWA Health Cooperative (Shri Gujarat Swashrayi Mahila Lok Swasthya Sahakari Mandli Ltd) approved on the 14th October 2010.

Study design

Cluster randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Health seeking behaviour for commonly claimed for illnesses

Intervention

Interventions in the treatment group are:
1. Focused group health education sessions for women, delivered by community health workers, and community media on commonly claimed for conditions (waterborne disease, fever/malaria and hysterectomy)
2. Facilitated referral to outpatient facilities by community health workers
3. Additional capacity building and support for community health workers

In control areas, SEWA health cooperative's ongoing community health activities and VimoSEWA insurance programs will continue.

Treatment duration: At least 18 months.
Follow-up duration: 6 monthly follow-ups throughout intervention, to a total of 2 years.

Joint Sponsor:
VimoSEWA (India)
Chanda Niwas
Near Hariharanand Ashram
Ellis Bridge
Ahmedabad 380006
India

Additional scientific contact details:
Dr Ajay Mahal
Alan and Elizabeth Finkel Chair of Global Health
School of Public Health and Preventive Medicine, Monash University
Third Floor, Burnet Building
Alfred Hospital
Melbourne, VIC 3004
Australia
T: +61 (0)3 990 30 028
E: amahal@hsph.harvard.edu

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Hospitalisation patterns for primary illness and hysterectomy, measured by household surveys and VimoSEWA claims records. Measured 6-monthly for 2 years.

Secondary outcome measures

1. Health seeking behaviour for primary illness and management of gynecological conditions
2. Health care related expenditure
3. Incidence (reported) of common illness

Measured 6-monthly for 2 years.

Overall trial start date

15/11/2010

Overall trial end date

15/05/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Cluster inclusion:
1. Village and urban settlement clusters
2. Served by SEWA community health workers
3. Covered by VimoSEWA insurance
4. Area membership of at least 30 policies

Individual inclusion:
1. SEWA members (adult women aged 18 to 60 years) currently enrolled in VimoSEWA insurance (for insured group)
2. Women residents of the same area not insured by VimoSEWA (control group)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1980

Participant exclusion criteria

Cluster exclusion:
Village and slum clusters not covered by both SEWA community health workers and VimoSEWA insurance.

Individual exclusion:
Women whose homes could not be located from the insurance registry or women who no longer reside at the given address.

Recruitment start date

15/11/2010

Recruitment end date

15/05/2012

Locations

Countries of recruitment

India

Trial participating centre

SEWA Health
Ahmedabad
380006
India

Sponsor information

Organisation

SEWA Health Cooperative (India)

Sponsor details

Shri Gujarat Swashrayi Mahlia Lok Swasthya Sahakari Mandli Ltd
Chanda Niwas
Near Hariharanand Ashram
Ellis Bridge
Ahmedabad
380006
India
+91 (0)79 265 80 530
social@sewass.org

Sponsor type

Research organisation

Website

http://www.sewainsurance.org

Funders

Funder type

Research organisation

Funder name

International Labour Organisation (ILO) (Switzerland) - Microinsurance Innovation Facility (ref: R2-149)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes