Health LiteracyNCT03973606
Assessment of the Health Literacy Among Arab Women in East Jerusalem
A study testing Heath literacy assessment in Arab women in East Jerusalem in people with Health Literacy and Cardiovascular Diseases, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
This is a two-stage study: The objective of the first stage is to explore health literacy (HL) needs and preferences of Arab women through conducting Focus Group Discussions (FGDs). The second stage will employ conducting a HL intervention tailored to the participants' needs and preferences as presented in the FGDs. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Literacy, Cardiovascular Diseases
- What is being tested?
- Heath literacy assessment in Arab women in East Jerusalem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Jul 2020to 30 Sep 2023
- 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 18 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All women aged 18-85 that attend and participate in the community's women's groups
- They must speak Arabic
Who cannot join
- Not in the age range of 18-85.
- Do not speak Arabic.
Trial locations and contacts
1 site in 1 country.
About this study
This is a two-stage study: The objective of the first stage is to explore health literacy (HL) needs and preferences of Arab women through conducting Focus Group Discussions (FGDs).
The second stage will employ conducting a HL intervention tailored to the participants' needs and preferences as presented in the FGDs. Objectives include increasing the percentage of women who utilize patient-doctor communication skills and increasing their cardiovascular disease (CVD) knowledge.The intervention consists of four sessions that will be conducted in municipality-sponsored women's groups in Jerusalem and other Arab communities. Questionnaires will be completed before and three months after the intervention. The study answers the following: Can HL workshops improve patient-doctor communication skills and CVD knowledge in Arab women.
Read the detailed description
Arab women in Israel are at high risk of low health literacy due to lower levels of education and low socio-economic status. Health literacy (HL) refers to the skills and competencies enabling people to obtain and interpret health information and apply their knowledge to inform health-related decision-making. It's also defined as "the degree to which individuals have the capacity to obtain, understand, and process basic health information and services needed to make appropriate health decisions".
The objective of the first stage of the study is to explore health literacy needs and preferences of Arab women through conducting Focus Group Discussions (FGDs) with women in East Jerusalem. Six different focus groups will be conducted at three of the six municipality community centers in East Jerusalem. Participants will be recruited through identified community centers.
Each group will meet once for up to two hours. The study will be explained to them by an investigator who has been trained in the administration of focus groups, and they will be asked to sign a consent form. Discussions will be recorded without the names of the participants (they will be instructed not to use their names once the recording begins). At the end of the meeting, each participant will receive a bag and pamphlets with information regarding women's health.
The second stage will employ conducting a HL intervention tailored to the participants' needs and preferences as presented in the FGDs. Objectives include increasing the percentage of women who utilize patient-doctor communication skills and increasing their cardiovascular disease (CVD) knowledge.The intervention consists of four sessions that will be conducted in municipality-sponsored women's groups in Jerusalem and other Arab communities. Questionnaires will be completed before and three months after the intervention. The study answers the following: Can HL workshops improve patient-doctor communication skills and CVD knowledge in Arab women.
- Conditions
- Health Literacy, Cardiovascular Diseases
- Being tested
- Heath literacy assessment in Arab women in East Jerusalem
- Keywords
- Health literacy, East Jerusalem, Focus groups, Arabic Women
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heath literacy assessment in Arab women in East JerusalemOther
Also called Health literacy workshop
A 4-sessions intervention to increase the participant's self-efficacy when interacting with their physician and increase their cardiovascular health knowledge.
| Study group | Role | What they receive |
|---|---|---|
| Arab Women health literacy focus groups | No intervention | Arab women in East Jerusalem will be part of focus groups. During the focus groups, a set of pre-prepared questions will be presented to the participants. The focus groups will be recorded and analyzed verbatim. |
| Health literacy workshop | Experimental | Women from East-Jerusalem and other Arab communities in Israel will be invited to participate in a 4-sessions workshop designed to improve health literacy, self-efficacy when interacting with their physician and increase their cardiovascular health knowledge. Receives: Other: Heath literacy assessment in Arab women in East Jerusalem |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of health literacy level and elucidate factors that will improve health literacy (barriers, incentives, etc.…) among Arab women in East Jerusalem
The assessment will be done through conduction of focus groups. Focus groups will be audio- recorded, transcribed and analyzed using Systematic text condensation, a descriptive and explorative analysis strategy. Which consists of four steps: 1) total impression - from chaos to themes; 2) identifying and sorting meanings units - from themes to codes; 3) condensation - from code to meaning; 4) synthesizing - from condensation to descriptions and concepts. It is expected that six focus groups will be sufficient to achieve saturation of themes. If results are not sufficient, investigators will ask to increase the number of focus groups.
Measured: within 6 months
Change in cardiovascular disease knowledge
A self report questionnaire based on the American Heart Association's Cardiovascular, and assess the knowledge regarding heart attack symptoms, by answering yes/no to each item.
Measured: At baseline and three months after intervention
Change in perceived efficacy in patient-physician interaction
Will be assessed using the 10-item Perceived Efficacy in Patient-Physician Interaction (PEPPI) (Maly, Frank, Marshall, Diametteo, Reuben, 1998). Participants respond to each question on a scale of 1 to 10, with 10 representing "very confident,'' and 1 representing "not at all confident". Higher scores represent positive outcome.
Measured: At baseline and three months after intervention
Change in remembering doctor's recommendations and reading blood test results
A 2-item version derived from the Perceived Efficacy in Patient-Physician Interaction (PEPPI). Participants respond to each question on a scale of 1 to 5, with 5 representing "very confident,'' and 1 representing "not at all confident". Higher scores represent positive outcome.
Measured: At baseline and three months after intervention
change in health literacy
Will be assessed using the Health Literacy Survey-Europe-Q16 (HLS-EU-Q16) a 16 question research instrument adapted for use in Israel. Participants respond to each question on a scale of 1 to 4, with 4 representing "fairly easy,'' and 1 representing "very difficult". Higher scores represent positive outcome.
Measured: At baseline and three months after intervention
Change in preparation for doctor's visit
A 6-item questionnaire represents preferred actions that participant\pants do before their doctor appointment. The more items are selected, the higher the score is, hence representing a positive outcome.
Measured: At baseline and three months after intervention
Secondary outcomes (2)
Change in Self-Rated Status of Health (SRH)
A validated single item health measure in which participants rate the current status of their own health on a five-point scale, from excellent to poor
Measured: At baseline and three months after intervention
Change in perceived efficacy in reading and understanding the instruction for taking medications
Participants will be asked "how confident do you feel you are able to follow the instructions on the label of a medication bottle?"
Measured: At baseline and three months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start30 Jul 2020
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
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.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Model description
- A 4-sessions workshop to improve health literacy among Arab women in Israel, with pre-post evaluation.
- Masking
- None (open label)
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donna R Zwas, Hadassah Medical Organization
- Investigators
- Donna Zwas, MD MPH, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03973606
- Sponsor's protocol ID
- HMO007819
- Status last verified
- Dec 2025
- First submitted
- 23 May 2019
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998 Jul;46(7):889-94. doi: 10.1111/j.1532-5415.1998.tb02725.x.
PubMed 9670878
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Health Literacy Among Arab Women in East Jerusalem
- ClinicalTrials.gov ID
- NCT03973606
- Acronym / sponsor ID
- HMO007819
- Conditions
- Health Literacy, Cardiovascular Diseases
- Keywords
- Health literacy, East Jerusalem, Focus groups, Arabic Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 4 Jun 2019 (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.
This is a two-stage study: The objective of the first stage is to explore health literacy (HL) needs and preferences of Arab women through conducting Focus Group Discussions (FGDs).
The second stage will employ conducting a HL intervention tailored to the participants' needs and preferences as presented in the FGDs. Objectives include increasing the percentage of women who utilize patient-doctor communication skills and increasing their cardiovascular disease (CVD) knowledge.The intervention consists of four sessions that will be conducted in municipality-sponsored women's groups in Jerusalem and other Arab communities. Questionnaires will be completed before and three months after the intervention. The study answers the following: Can HL workshops improve patient-doctor communication skills and CVD knowledge in Arab women.
Detailed description
Arab women in Israel are at high risk of low health literacy due to lower levels of education and low socio-economic status. Health literacy (HL) refers to the skills and competencies enabling people to obtain and interpret health information and apply their knowledge to inform health-related decision-making. It's also defined as "the degree to which individuals have the capacity to obtain, understand, and process basic health information and services needed to make appropriate health decisions".
The objective of the first stage of the study is to explore health literacy needs and preferences of Arab women through conducting Focus Group Discussions (FGDs) with women in East Jerusalem. Six different focus groups will be conducted at three of the six municipality community centers in East Jerusalem. Participants will be recruited through identified community centers.
Each group will meet once for up to two hours. The study will be explained to them by an investigator who has been trained in the administration of focus groups, and they will be asked to sign a consent form. Discussions will be recorded without the names of the participants (they will be instructed not to use their names once the recording begins). At the end of the meeting, each participant will receive a bag and pamphlets with information regarding women's health.
The second stage will employ conducting a HL intervention tailored to the participants' needs and preferences as presented in the FGDs. Objectives include increasing the percentage of women who utilize patient-doctor communication skills and increasing their cardiovascular disease (CVD) knowledge.The intervention consists of four sessions that will be conducted in municipality-sponsored women's groups in Jerusalem and other Arab communities. Questionnaires will be completed before and three months after the intervention. The study answers the following: Can HL workshops improve patient-doctor communication skills and CVD knowledge in Arab women.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A 4-sessions workshop to improve health literacy among Arab women in Israel, with pre-post evaluation.
| Arm | Type | Receives |
|---|---|---|
| Arab Women health literacy focus groups | No intervention | –Arab women in East Jerusalem will be part of focus groups. During the focus groups, a set of pre-prepared questions will be presented to the participants. The focus groups will be recorded and analyzed verbatim. |
| Health literacy workshop | Experimental | Other: Heath literacy assessment in Arab women in East JerusalemWomen from East-Jerusalem and other Arab communities in Israel will be invited to participate in a 4-sessions workshop designed to improve health literacy, self-efficacy when interacting with their physician and increase their cardiovascular health knowledge. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All women aged 18-85 that attend and participate in the community's women's groups
- They must speak Arabic
Key exclusion criteria (2 listed)
- Not in the age range of 18-85.
- Do not speak Arabic.
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 |
|---|---|---|
| Heath literacy assessment in Arab women in East JerusalemAlso: Health literacy workshopA 4-sessions intervention to increase the participant's self-efficacy when interacting with their physician and increase their cardiovascular health knowledge. | Other | Health literacy workshop |
Primary outcome
assessment of health literacy level and elucidate factors that will improve health literacy (barriers, incentives, etc.…) among Arab women in East Jerusalem
Time frame: within 6 months
The assessment will be done through conduction of focus groups. Focus groups will be audio- recorded, transcribed and analyzed using Systematic text condensation, a descriptive and explorative analysis strategy. Which consists of four steps: 1) total impression - from chaos to themes; 2) identifying and sorting meanings units - from themes to codes; 3) condensation - from code to meaning; 4) synthesizing - from condensation to descriptions and concepts. It is expected that six focus groups will be sufficient to achieve saturation of themes. If results are not sufficient, investigators will ask to increase the number of focus groups.
Change in cardiovascular disease knowledge
Time frame: At baseline and three months after intervention
A self report questionnaire based on the American Heart Association's Cardiovascular, and assess the knowledge regarding heart attack symptoms, by answering yes/no to each item.
Change in perceived efficacy in patient-physician interaction
Time frame: At baseline and three months after intervention
Will be assessed using the 10-item Perceived Efficacy in Patient-Physician Interaction (PEPPI) (Maly, Frank, Marshall, Diametteo, Reuben, 1998). Participants respond to each question on a scale of 1 to 10, with 10 representing "very confident,'' and 1 representing "not at all confident". Higher scores represent positive outcome.
Change in remembering doctor's recommendations and reading blood test results
Time frame: At baseline and three months after intervention
A 2-item version derived from the Perceived Efficacy in Patient-Physician Interaction (PEPPI). Participants respond to each question on a scale of 1 to 5, with 5 representing "very confident,'' and 1 representing "not at all confident". Higher scores represent positive outcome.
change in health literacy
Time frame: At baseline and three months after intervention
Will be assessed using the Health Literacy Survey-Europe-Q16 (HLS-EU-Q16) a 16 question research instrument adapted for use in Israel. Participants respond to each question on a scale of 1 to 4, with 4 representing "fairly easy,'' and 1 representing "very difficult". Higher scores represent positive outcome.
Change in preparation for doctor's visit
Time frame: At baseline and three months after intervention
A 6-item questionnaire represents preferred actions that participant\pants do before their doctor appointment. The more items are selected, the higher the score is, hence representing a positive outcome.
2 secondary outcomes
Change in Self-Rated Status of Health (SRH)
Time frame: At baseline and three months after intervention
Change in perceived efficacy in reading and understanding the instruction for taking medications
Time frame: At baseline and three months after intervention
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 22 Dec 2025.
- Background: PubMed 9670878Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998 Jul;46(7):889-94. doi: 10.1111/j.1532-5415.1998.tb02725.x.
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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.
Donna Zwas, MD MPH principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heath literacy assessment in Arab women in East Jerusalem in people with Health Literacy and Cardiovascular Diseases, run by Hadassah Medical Organization at 1 site in Israel.
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 2 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 22 Dec 2025. 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 Israel. 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?
assessment of health literacy level and elucidate factors that will improve health literacy (barriers, incentives, etc.…) among Arab women in East Jerusalem (time frame: within 6 months). The study lists 6 primary outcomes in all. 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 NCT03973606, 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 22 Dec 2025.