NCT03973606

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
306

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

July 30, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

3.2 years

First QC Date

May 23, 2019

Last Update Submit

December 16, 2025

Conditions

Keywords

Health literacyEast JerusalemFocus groupsArabic Women

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Change in Self-Rated Status of Health (SRH)

    At baseline and three months after intervention

  • Change in perceived efficacy in reading and understanding the instruction for taking medications

    At baseline and three months after intervention

Study Arms (2)

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.

Other: Heath literacy assessment in Arab women in East Jerusalem

Interventions

A 4-sessions intervention to increase the participant's self-efficacy when interacting with their physician and increase their cardiovascular health knowledge.

Also known as: Health literacy workshop
Health literacy workshop

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All women aged 18-85 that attend and participate in the community's women's groups
  • They must speak Arabic

You may not qualify if:

  • Not in the age range of 18-85.
  • Do not speak Arabic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beit-Safafa community center

Jerusalem, 95822, Israel

Location

Related 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.

    PMID: 9670878BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Donna Zwas, MD MPH

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: A 4-sessions workshop to improve health literacy among Arab women in Israel, with pre-post evaluation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Linda Joy Pollin Cardiovascular Wellness Center for Women

Study Record Dates

First Submitted

May 23, 2019

First Posted

June 4, 2019

Study Start

July 30, 2020

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations