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Digital Health Literacy Intervention for Disadvantaged Women During Corona

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ClinicalTrials.gov Identifier: NCT04603092
Recruitment Status : Not yet recruiting
First Posted : October 26, 2020
Last Update Posted : February 3, 2021
Sponsor:
Collaborators:
doctHERs
Saglik Bilimleri Universitesi
Information provided by (Responsible Party):
Sara Rizvi Jafree, Forman Christian College, Pakistan

Brief Summary:
The aim is to deliver a digital health literacy intervention to disadvantaged women to improve their health behaviors with regard to (i) hygiene and sanitation, and (ii) coronavirus awareness and prevention in four provinces of Pakistan through women community health workers.

Condition or disease Intervention/treatment Phase
Health Literacy Behavioral: Digital Health Literacy Intervention Not Applicable

Detailed Description:
There is a need to continue primary healthcare services through digital communication for disadvantaged women living in underdeveloped areas of Pakistan, especially in the age of coronavirus pandemic, social distancing, and lockdown of communities. This project will be the first of its kind in aiming to provide women with a smartphone and digital access for a digital health literacy intervention through community healthcare workers. The majority of poor women in Pakistan who are dependent on primary health services: 1. suffer from health challenges more than men due to multiple social and structural disadvantages, 2. are the dominant care-providers and nurturers in the home, and 3. need support in understanding public health messages during health crises due to low health literacy and awareness. The digital health literacy intervention will be delivered in target two areas: (i) hygiene and sanitation, and (ii) coronavirus awareness and prevention. Women will be sampled from disadvantaged areas across the four provinces of Pakistan- Baluchistan, KPK, Punjab, and Sindh. A target of 1,000 women will comprise the sample with 500 women each assigned to the control and experiment group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The control and experiment group will both be provided a hard-copy of a health literacy booklet and electronically administered the: (a) base-line survey, and (b) the pre-test survey and the post-test survey.

The experiment group will receive a digital health literacy intervention in two target areas: (i) hygiene and sanitation, and (ii) coronavirus awareness and prevention.

Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Prevention
Official Title: Digital Health Literacy Intervention by Community Health Workers for Corona Preventive Behaviors for Disadvantaged Women at Primary Level
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Literacy

Arm Intervention/treatment
Experimental: Disadvantaged women in primary setting receiving digital health literacy intervention
The study population will comprise of disadvantaged women dependent on primary healthcare services, who do not have access to digital tools (smartphone, computer, laptop) or Wifi in their home. This group will receive the digital health literacy intervention.
Behavioral: Digital Health Literacy Intervention

Willing women participants will be provided equipment with instructions for the intervention, including a smartphone and a 4G Wifi gadget. The health literacy intervention, delivered to the experiment group, will last three months and will include a combination of the following four components:

Component 1: Health literacy video tutorial. Component 2: Virtual one-on-one weekly meetings. Component 3: Monthly group virtual meetings and Whatsapp group. Component 4: Provision and guidance of a self-management chart.


No Intervention: Disadvantaged women in primary setting not receiving digital health literacy intervention
The study population will comprise of disadvantaged women dependent on primary healthcare services, who do not have access to digital tools (smartphone, computer, laptop) or Wifi in their home. This control group will not receive the digital health literacy intervention.



Primary Outcome Measures :
  1. Changes in health directed behavior [ Time Frame: 3 months ]
    A total of 135 questions will be used, with five domains being covered through the following surveys: (i) Health Education Impact Questionnaire, (ii) Survey on Hygiene Knowledge, Attitude and Practice, (iii) Homecare of Covid Survey, (iv) Survey for mobile u-Health program by Ahn, Bae, and Kim and (v) Women's Health Care Experiences Survey. It is a five-point Likert-type scale (strongly agree - agree - neutral - disagree - strongly disagree). The highest value of the scale is 6 and the lowest value is 1; with 6 points showing strong agreement with the item statement (E.g. Q80. We are cleaning the eating, drinking, and cooking utensil with dish detergent after every use).



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Disadvantaged women dependent on primary healthcare services
  • Women of the reproductive age group, 15 years to 49 years

Exclusion Criteria:

  • Women above 49 years
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sara Rizvi Jafree, Assistant Professor, Department of Sociology, Forman Christian College, Pakistan
ClinicalTrials.gov Identifier: NCT04603092    
Other Study ID Numbers: FormanChristianC
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The SPSS data set will be publicly available. No names of participants will be taken during data collection. Participants will be allocated a code.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 6 months

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sara Rizvi Jafree, Forman Christian College, Pakistan:
digital health literacy
community healthcare workers
coronavirus
primary healthcare
maternal and child health