NCT05389501

Brief Summary

Some of the challenges Pakistan faces in priority areas of national relevance include absence of social policy to improve innovative governance and reform of the primary healthcare system, especially for maternal and child health. One integral tool for development of social policy in a country is the integration of the social work profession at primary level. Developed countries have progressed by strengthening the primary workforce with social workers, who have contributed by developing a social policy protection floor for mother and child in primary level communities through: (i) assessment of community needs (e.g. for housing, health, education, and employment), (ii) robust data collection, (iii) political advocacy, and (iv) supporting literacy and counseling . In this way, there is potential to fill a gap by adding Social Workers to the primary health force team in Pakistan to investigate the following research questions:

  1. 1.Can a robust, objective, third-party Community Needs Assessment Report (by Social Workers) help to mobilize governments and policy-makers for improve planning and protective policies for disadvantaged communities?
  2. 2.Can a more comprehensive health electronic database be developed with both health and social variables to better plan policy development and develop a much-needed regional Index for Maternal Health and Wellbeing?
  3. 3.Can maternal and health outcomes be impacted positively by the following intervention this project plans to deliver: (i) Reproductive and Child Health; (ii) Hygiene and Sanitation \& Nutrition and Immunity Building; (iii) Health-Risk Behavior Modification; and (iv) Psychosocial Needs Assessment and Mental Health Awareness?
  4. 4.Can primary healthcare services become more efficient and effective (in teamwork and improved care plans for client) through interprofessional health workforce collaboration and supplementation of social workers to the team? The proposed project, lasting 24 months, will aid socio-economic development of the country by improving primary healthcare services, improving maternal and child health outcomes, improving preventive behavior overall in families, and strengthening the health workforce team. Improving preventive health also reduces national health costs in the long-run at an estimated USD 45 billion. Building an electronic database with both health and social indicators is integral for the planning of a more effective social and health policy in the future. Integrating social workers at primary level will create thousands of jobs per year for Pakistan and help develop the educations sector as well and provide opportunities for more health workforce development, like public health officers.
  5. 5.Development of a digital app and finalization of an Index for Maternal Health and Wellbeing
  6. 6.Preparation of a Community Assessment Needs Report for mobilization of social protection floor
  7. 7.A Pre-Post Test Survey to measure changes caused by intervention for: (i) Basic Clinical Health Indicators, (ii) Reproductive and Child Health, (iii) Hygiene and Sanitation \& Nutrition and Immunity Building, (iv) Health-Risk Behavior Modification; and (v) Psychosocial Assessment and Therapy needs.
  8. 8.Dissemination of findings to government bodies, policy-makers, scholars, and researchers to mobilize social policy support and improved governance at primary level through the project pilot model.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

May 9, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

1.9 years

First QC Date

May 9, 2022

Last Update Submit

May 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in health literacy of women of reproductive years over 24 months

    We will use the standardized international survey: "Knowledge and Reported Practices of Women on Maternal and Child Health" (Kanu, Tang, \& Liu, 2014). The following domain areas will be measured including: (i) Pregnancy and antenatal care; (ii) Health knowledge; (iii) Accessing health care; (iv) Vaccinations coverage; (v) Child's father/husband's involvement in maternal and child care; and (vi) Household factors (e.g. hygiene, water and food preparation, waste disposable, and toilet quality, etc.).

    2 years

Study Arms (2)

Intervention Group

EXPERIMENTAL

The Experiment Group will receive the following services from the community social worker: 1\. Developing Database on Digital App 2. Community Needs Assessment 3 Pre-Post Test Survey 4. Existing services by government of Pakistan (BHU/ LHW) Additionally, the Experiment Group will receive the following services from the health social worker: 1. Psychosocial needs assessment and mental health awareness 2. Measurement of Basic Health Clinical Indicators 33\. Health Awareness \& Literacy for following areas: 1. Reproductive and Child Health 2. Hygiene and Sanitation \& Nutrition and Immunity Building 3. Health-Risk Behavior Modification

Behavioral: Social policy intervention to support women of reproductive years

Control Group

ACTIVE COMPARATOR

The Control Group will receive the following services from the community social worker: 1. Developing Database on Digital App 2. Community Needs Assessment 3 Pre-Post Test Survey 4\. Existing services by government of Pakistan (BHU/ LHW)

Behavioral: Social policy intervention to support women of reproductive years

Interventions

The project team will attempt to address this challenge by delivering the following interventions through social workers in underdeveloped primary healthcare settings to promote maternal and child health: 1. Developing a database on a digital app of participants in the study and use the data for development of an Index for Maternal Health and Wellbeing 2. Conducting a Community Assessment Needs 3. Conduct a psychosocial needs assessment 4. Develop interprofessional health workforce collaboration 5. Measure basic clinical health indicators 6. Provide health awareness and literacy training to participants

Control GroupIntervention Group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Poor women of reproductive years
  • Existing clients of doorstep visiting lady health workers (LHWs)

You may not qualify if:

  • \- Women not of reproductive years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Forman Christian College University

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Forman Christian College

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Study Officials

  • Kauser R Abdullah Malik, PhD

    Forman Christian College, Pakistan

    STUDY CHAIR

Central Study Contacts

Sara Rizvi Jafree, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor & Chair, Department of Sociology

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 25, 2022

Study Start

June 1, 2022

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations