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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03973606
Other study ID # HMO007819
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 30, 2020
Est. completion date December 31, 2025

Study information

Verified date April 2023
Source Hadassah Medical Organization
Contact Donna Zwas, MD,MPH
Phone +97226779451
Email dannaz@hadassah.org.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2025
Est. primary completion date June 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - All women aged 18-85 that attend and participate in the community's women's groups - They must speak Arabic Exclusion Criteria: - Not in the age range of 18-85. - Do not speak Arabic.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Heath literacy assessment in Arab women in East Jerusalem
A 4-sessions intervention to increase the participant's self-efficacy when interacting with their physician and increase their cardiovascular health knowledge.

Locations

Country Name City State
Israel Beit-Safafa community center Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. within 6 months
Primary 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. At baseline and three months after intervention
Primary 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. At baseline and three months after intervention
Primary 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. At baseline and three months after intervention
Primary 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. At baseline and three months after intervention
Primary 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. At baseline and three months after intervention
Secondary 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 At baseline and three months after intervention
Secondary 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?" At baseline and three months after intervention
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