NCT03203018

Brief Summary

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?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
407

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

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

Study Start

First participant enrolled

September 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

2.9 years

First QC Date

June 26, 2017

Last Update Submit

January 22, 2019

Conditions

Keywords

Cardiovascular Diseases (CVD)Community-based interventionSocio-economic status (SES)Health literacy (HL)

Outcome Measures

Primary Outcomes (1)

  • Change in preparation for doctor's visit

    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

    Before intervention and three months after intervention

Secondary Outcomes (4)

  • Change in cardiovascular disease knowledge

    At baseline and three month after intervention

  • Change in perceived efficacy in patient-physician interaction

    At baseline and three month after intervention

  • Change in knowledge of health measures

    At baseline and three month after intervention

  • Change in reading blood test results

    At baseline and three month after intervention

Study Arms (1)

Women participating in HL intervention

EXPERIMENTAL

Groups of women from disadvantaged communities will participate in a three session health literacy workshop

Behavioral: Interactive workshop based on community specific needs

Interventions

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.

Women participating in HL intervention

Eligibility Criteria

Age20 Years - 90 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women from Jerusalem
  • Hebrew and Arabic speakers

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, 91120, Israel

Location

Related Publications (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.

    PMID: 19372101BACKGROUND
  • Safeer RS, Keenan J. Health literacy: the gap between physicians and patients. Am Fam Physician. 2005 Aug 1;72(3):463-8.

    PMID: 16100861BACKGROUND
  • 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/

    PMID: 25009856BACKGROUND
  • 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.

    PMID: 12038721BACKGROUND
  • 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.

    PMID: 15610334BACKGROUND
  • 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.

    PMID: 9844076BACKGROUND
  • Martin LR, Williams SL, Haskard KB, Dimatteo MR. The challenge of patient adherence. Ther Clin Risk Manag. 2005 Sep;1(3):189-99.

    PMID: 18360559BACKGROUND
  • 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.

MeSH Terms

Conditions

CommunicationCardiovascular Diseases

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Donna Zwas, MD, MPH

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This is a pre/post study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Linda Joy Pollin Cardiovascular Wellness Center for Women

Study Record Dates

First Submitted

June 26, 2017

First Posted

June 29, 2017

Study Start

September 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations