Health LiteracyNCT04603092
Digital Health Literacy Intervention for Disadvantaged Women During Corona
A study testing Digital Health Literacy Intervention in people with Health Literacy, run by Forman Christian College, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Health Literacy
- What is being tested?
- Digital Health Literacy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,010 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Disadvantaged women dependent on primary healthcare services
- Women of the reproductive age group, 15 years to 49 years
Who cannot join
- Women above 49 years
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Forman Christian College University
Lahore, Punjab Province, 54000
About this study
Official title: Digital Health Literacy Intervention by Community Health Workers for Corona Preventive Behaviors for Disadvantaged Women at Primary Level
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.
Read the 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.
- Conditions
- Health Literacy
- Being tested
- Digital Health Literacy Intervention
- Keywords
- digital health literacy, community healthcare workers, coronavirus, primary healthcare, maternal and child health
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health Literacy InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Disadvantaged women in primary setting receiving digital health literacy intervention | Experimental | 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. Receives: Behavioral: Digital Health Literacy Intervention |
| Disadvantaged women in primary setting not receiving digital health literacy intervention | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in health directed behavior
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start1 Mar 2021
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health LiteracyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forman Christian College, Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- doctHERs, Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Sara Rizvi Jafree, Forman Christian College, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603092
- Sponsor's protocol ID
- FormanChristianC
- Status last verified
- May 2022
- First submitted
- 19 Oct 2020
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The SPSS data set will be publicly available. No names of participants will be taken during data collection. Participants will be allocated a code.
Publications
Jafree SR, Bukhari N, Muzamill A, Tasneem F, Fischer F. Digital health literacy intervention to support maternal, child and family health in primary healthcare settings of Pakistan during the age of coronavirus: study protocol for a randomised controlled trial. BMJ Open. 2021 Mar 2;11(3):e045163. doi: 10.1136/bmjopen-2020-045163.
PubMed 33653760
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Health Literacy Intervention by Community Health Workers for Corona Preventive Behaviors for Disadvantaged Women at Primary Level
- ClinicalTrials.gov ID
- NCT04603092
- Acronym / sponsor ID
- FormanChristianC
- Conditions
- Health Literacy
- Keywords
- digital health literacy, community healthcare workers, coronavirus, primary healthcare, maternal and child health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- Forman Christian College, PakistanUniversity, hospital or other
- Collaborators
- doctHERs, Saglik Bilimleri Universitesi
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Disadvantaged women in primary setting receiving digital health literacy intervention | Experimental | Behavioral: Digital Health Literacy InterventionThe 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. |
| Disadvantaged women in primary setting not receiving digital health literacy intervention | No 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. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Disadvantaged women dependent on primary healthcare services
- Women of the reproductive age group, 15 years to 49 years
Key exclusion criteria (1 listed)
- Women above 49 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Health Literacy InterventionWilling 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. | Behavioural | Disadvantaged women in primary setting receiving digital health literacy intervention |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Derived from this study: PubMed 33653760Jafree SR, Bukhari N, Muzamill A, Tasneem F, Fischer F. Digital health literacy intervention to support maternal, child and family health in primary healthcare settings of Pakistan during the age of coronavirus: study protocol for a randomised controlled trial. BMJ Open. 2021 Mar 2;11(3):e045163. doi: 10.1136/bmjopen-2020-045163.
- Individual participant dataSharing planned: Yes. The SPSS data set will be publicly available. No names of participants will be taken during data collection. Participants will be allocated a code.
Related trials for Health Literacy
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Not yet recruiting
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
Physical Activity, Intellectual Disabilities
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Not yet recruiting
Sperm, Exposure and Endocrine Disruptors
Fertility, Male Fertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health Literacy Intervention in people with Health Literacy, run by Forman Christian College, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in health directed behavior (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04603092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.