- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03203018
Health Literacy and Cardiovascular Knowledge Workshop in Women From Disadvantaged Communities
The current health literacy (HL) pilot intervention was designed through focus groups with women in low socio-economic status (SES) communities. The primary HL issue identified was communication challenges at doctors' visits. As a unique HL intervention tailored to the participants' preferences, this intervention can serve as a model for improving HL in similar communities worldwide.
Objectives include increasing the percentage of women who utilize patient-doctor communication skills and increasing their cardiovascular disease (CVD) knowledge. A unique HL intervention tailored to the participants' preferences was designed which consisted of three workshops conducted in municipality-sponsored women's groups in low SES Jerusalem communities. Questionnaires were 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 low SES women?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The current health literacy (HL) pilot intervention was designed through focus groups with women in low socio-economic status (SES) communities. The primary HL issue identified was communication challenges at doctors' visits. As a unique HL intervention tailored to the participants' preferences, this intervention can serve as a model for improving HL in similar communities worldwide.
Objectives include increasing the percentage of women who utilize patient-doctor communication skills, prepare for their doctor's visit, and increase their cardiovascular disease (CVD) knowledge.
In order to accomplish these objectives, a unique HL intervention tailored to the participants' preferences was designed which consisted of three workshops conducted in municipality-sponsored women's groups in low SES Jerusalem communities. This intervention consisted of a three consecutive weekly workshop conducted in women's support groups in disadvantaged communities in Jerusalem. The workshop includes women's heart health sessions, as well as sessions about how to make the most of a doctor's visit, which includes role play and teach back method practice. A self-admitted questionnaire regarding CVD and relevant HL knowledge and behaviors was completed at the beginning of the intervention, and three months after the last session.
This study answers the question of whether a three session HL workshop for women can successfully raise their CVD knowledge and awareness, as well as change behaviors of women in terms of preparing for doctor's visits.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Jerusalem, Israel, 91120
- Hadassah Medical Organization, Jerusalem, Israel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women from Jerusalem
- Hebrew and Arabic speakers
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Women participating in HL intervention
Groups of women from disadvantaged communities will participate in a three session health literacy workshop
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Intervention components will include lecture on women's CVD, workshop on how to prepare for a doctor's visit, patient's rights and patient-doctor communication skills, and a "know your numbers" workshop, including understanding blood test results.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in preparation for doctor's visit
Time Frame: Before intervention and three months after intervention
|
Women complete self report survey indicating if whether or not they prepared for their doctor's visit, whether or not they prepared a list of questions for their doctor's visit, a list of symptoms, a list of medications, and their medical background information
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Before intervention and three months after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cardiovascular disease knowledge
Time Frame: At baseline and three month after intervention
|
Cardiovascular disease knowledge will be assessed through a self report questionnaire based on the American Heart Association's Cardiovascular disease knowledge survey items
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At baseline and three month after intervention
|
Change in perceived efficacy in patient-physician interaction
Time Frame: At baseline and three month after intervention
|
Perceived efficacy in patient-physician interaction (PEPPI) will be assessed via PEPPI self report scale (Maly, Frank, Marshall, Diametteo, Reuben, 1998)
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At baseline and three month after intervention
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Change in knowledge of health measures
Time Frame: At baseline and three month after intervention
|
Knowledge of health measures will be assessed through self report questionnaire
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At baseline and three month after intervention
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Change in reading blood test results
Time Frame: At baseline and three month after intervention
|
Reading blood test results will be assessed through self report questionnaire
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At baseline and three month after intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Donna Zwas, MD, MPH, Hadassah Medical Organization
Publications and helpful links
General Publications
- Institute of Medicine (US) Committee on Health Literacy; Nielsen-Bohlman L, Panzer AM, Kindig DA, editors. Health Literacy: A Prescription to End Confusion. Washington (DC): National Academies Press (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK216032/
- Dewalt DA, Berkman ND, Sheridan S, Lohr KN, Pignone MP. Literacy and health outcomes: a systematic review of the literature. J Gen Intern Med. 2004 Dec;19(12):1228-39. doi: 10.1111/j.1525-1497.2004.40153.x.
- Baker DW, Parker RM, Williams MV, Clark WS. Health literacy and the risk of hospital admission. J Gen Intern Med. 1998 Dec;13(12):791-8. doi: 10.1046/j.1525-1497.1998.00242.x.
- Safeer RS, Keenan J. Health literacy: the gap between physicians and patients. Am Fam Physician. 2005 Aug 1;72(3):463-8.
- Peerson A, Saunders M. Health literacy revisited: what do we mean and why does it matter? Health Promot Int. 2009 Sep;24(3):285-96. doi: 10.1093/heapro/dap014. Epub 2009 Apr 16.
- Williams MV, Davis T, Parker RM, Weiss BD. The role of health literacy in patient-physician communication. Fam Med. 2002 May;34(5):383-9.
- Martin LR, Williams SL, Haskard KB, Dimatteo MR. The challenge of patient adherence. Ther Clin Risk Manag. 2005 Sep;1(3):189-99.
- Greenberg KL, Leiter E, Donchin M, Agbaria N, Karjawally M, Zwas DR. Cardiovascular health literacy and patient-physician communication intervention in women from disadvantaged communities. Eur J Prev Cardiol. 2019 Nov;26(16):1762-1770. doi: 10.1177/2047487319853900. Epub 2019 Jun 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 235HLT-HMO-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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