Condition category
Musculoskeletal Diseases
Date applied
03/10/2019
Date assigned
08/10/2019
Last edited
08/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People with disability (PWD) amount to 15% of the world population and World Health Organization (WHO) estimates that 80% of them live in developing countries (World Health Organization, 2016; World Health Organization and the World Bank, 2011). In India, there are about 26.8 million persons with disability which is about 2.21% of its population (Government of India, 2011). Evidence suggests that PWDs are more likely to experience adverse socioeconomic outcomes such as less education, poorer health outcomes, lower education achievements, less employment and higher rates of poverty than persons without disability (Government of India, 2011; World Bank, 2009; World Health Organization and the World Bank, 2011). Additionally, People with disability face barriers accessing health and rehabilitation services (World Health Organization, 2018).
This study aims at understanding the potential of Disabled People’s Networks in promoting disability inclusive development in Uttarakhand state, North India.

Who can participate?
Using a lottery system, we randomly allocated 20 villages to the intervention arm and 19 to the control arm. Based on an adapted Key Informant methodology, we identified all people with disability who were not currently involved in a disabled people’s organisation to participate. The minimum age for participation was 15.

What does the study involve?
In the intervention clusters, local non-government organisations (NGOs) facilitated the formation of Disabled People’s Organisations (DPO) and motivated study participants to be involved in the activities of the DPOs. A curriculum and training program was also developed. Five NGOs, each within one of the intervention sites were selected to assist in the intervention study, involving support in DPO formation.
In the non-intervention clusters, no DPOs were facilitated but the ongoing disability work continued. The control group only received referrals for disabilities detected by RAD screening, but no additional assistance. They will receive the interventions at the end of this study.

Possible benefits and risks of participating
Disabled People’s Organisations could promote wellbeing, participation, and rights of people with a disability. DPOs also empowered people with a disability to actively express their priorities and needs.

Location of study centre
The study took place in 39 villages purposively selected from five distinct areas located in New Tehri and Dehradun districts of Uttarakhand.

Source of funding
The study was funded by Christian Blind Mission India.

Main contact
Dr Nathan Grills
ngrills@unimelb.edu.au

Trial website

Contact information

Type

Public

Primary contact

Dr Nathan Grills

ORCID ID

http://orcid.org/0000-0003-1228-3047

Contact details

Associate Prof and Public Health Physician
Nossal Institute for Global Health
University of Melbourne
333 Exhibition Street
Melbourne
3004
Australia
+61 3 8344 4299
ngrills@unimelb.edu.au

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IIPHH/TRCIEC/10/2014

Study information

Scientific title

A randomised controlled trial to assess the impact of DPO formation using the RAD and other evaluation tools

Acronym

NIDPO

Study hypothesis

Activities and services facilitated by Disabled People's Network (DPN) improve PWD's (people with a disability) well-being, community participation and access to services

Ethics approval

1. Approved 28/01/2015, Community Health Global Network, Uttarakhand Cluster (CHGN Uttarakhand Cluster, Disability Advisory Committee, India; +91 (0) 1360-253323; robert@eha-health.org), ref: n/a
2. Approved 26/06/2015, Indian Institute of Public Health – Hyderabad (ANV Arcade, Plot No.1, Amar Cooperative Society, Kavuri Hills, Madhapur, Hyderabad - 500081, A.P., INDIA; +91 40 49006003; murthy.gvs@iiphh.org), ref: IIPHH/TRCIEC/10/2014-1


Study design

Cluster randomized interventional trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please contact Dr Nathan Grills (ngrills@unimelb.edu.au) for a PIS.

Condition

Disability

Intervention

A cluster randomized interventional trial in the Dehradun district of Uttarakhand state in North India to evaluate the impact of DPOs (Disabled People's Organisations) on inclusion, wellbeing and participation.

Intervention arm: Participants in the intervention group would receive services faciliated by Disabled People's Networks. DPNs is a participatory model and participants were encouraged to ultimately determine the activities they undertake.

Uttarakhand Cluster of NGOs and Public Health Foundation of India would provide training in community mobilisation, advocacy of rights to health and education, bookkeeping, awareness-raising and access to government programs.

Local NGOs facilitated the DPO formation by regular home visits to individual families to motivate them to be involved in the activities of the DPOs. A curriculum and training program were also developed. Five NGOs were selected to assist in the intervention study, involving support in DPO formation.

The DPOs were encouraged to conduct regular disability group meetings to facilitate problem solving, advocacy and planning. As a part of the DPOs, persons with disabilities were encouraged to visit the block and district office and make at least three visits to the disability commissioner.

Control arm: For participants in the control group, current disability work would continue but no DPNs would be facilitated.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Well-being, community participation, and access to services assessed at baseline and endline (after DPN implementation) using the rapid assessment of disability (RAD) tool

Secondary outcome measures

none

Overall trial start date

01/01/2015

Overall trial end date

31/05/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Have a disability
2. Currently living in the selected villages
3. Aged >= 15 yrs
4. Not currently involved in a disabled people’s organisation

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

500

Total final enrolment

527

Participant exclusion criteria

1. Guardian unwilling or unable to give consent

Recruitment start date

01/04/2015

Recruitment end date

30/04/2017

Locations

Countries of recruitment

British Indian Ocean Territory, India

Trial participating centre

India
Community Health Global Network KHW, Rajpur Rd Rajpur
Dehradun
248139
India

Sponsor information

Organisation

Nossal Institute for Global Health

Sponsor details

University of Melbourne
333 Exhibition Street
Melbourne
3004
Australia
+61 3 8344 4299
ngrills@unimelb.edu.au

Sponsor type

University/education

Website

https://mspgh.unimelb.edu.au/centres-institutes/nossal-institute-for-global-health

Funders

Funder type

Charity

Funder name

CBM India

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Target journal for publication: BMC Public Health.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

30/11/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/10/2019: Trial’s existence confirmed by Community Health Global Network, Uttarakhand Cluster.