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Health LiteracyNCT03203018

Health Literacy and Cardiovascular Knowledge Workshop in Women From Disadvantaged Communities

A study testing Interactive workshop based on community specific needs in people with Health Literacy and Communication, run by Hadassah Medical Organization at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 90 years, women onlyHealthy volunteers can take part
Conditions the study is for
Health Literacy, Communication
What is being tested?
Interactive workshop based on community specific needs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
407 participants
Where
1 siteIsrael
Study dates
Sep 2015to Aug 2018
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 20 to 90 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women from Jerusalem
  • Hebrew and Arabic speakers

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Hadassah Medical Organization, Jerusalem, Israel

    Jerusalem, 91120

Other trials in Israel

About this study

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?

Read the 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.

Being tested
Interactive workshop based on community specific needs
Keywords
Cardiovascular Diseases (CVD), Community-based intervention, Socio-economic status (SES), Health literacy (HL)
Medical subject headings
Communication, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interactive workshop based on community specific needsBehavioural

    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.

Study groups in NCT03203018
Study groupRoleWhat they receive
Women participating in HL interventionExperimentalGroups of women from disadvantaged communities will participate in a three session health literacy workshop
Receives: Behavioral: Interactive workshop based on community specific needs

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Before intervention and three months after intervention

Secondary outcomes (4)

  1. Change in cardiovascular disease knowledge

    Cardiovascular disease knowledge will be assessed through a self report questionnaire based on the American Heart Association's Cardiovascular disease knowledge survey items

    Measured: At baseline and three month after intervention

  2. Change in perceived efficacy in patient-physician interaction

    Perceived efficacy in patient-physician interaction (PEPPI) will be assessed via PEPPI self report scale (Maly, Frank, Marshall, Diametteo, Reuben, 1998)

    Measured: At baseline and three month after intervention

  3. Change in knowledge of health measures

    Knowledge of health measures will be assessed through self report questionnaire

    Measured: At baseline and three month after intervention

  4. Change in reading blood test results

    Reading blood test results will be assessed through self report questionnaire

    Measured: At baseline and three month after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2017
  2. Study startSep 2015
  3. Primary completionAug 2018
  4. Study completionAug 2018

Resources

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
Not applicable
Intervention model
Single group
Model description
This is a pre/post study.
Masking
None (open label)
Enrolment
407 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03203018
Sponsor's protocol ID
235HLT-HMO-CTIL
Status last verified
Jan 2019
First submitted
26 Jun 2017
Last updated
23 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19372101

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

    PubMed 16100861

  • 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/

    PubMed 25009856

  • 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.

    PubMed 12038721

  • 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.

    PubMed 15610334

  • 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.

    PubMed 9844076

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

    PubMed 18360559

  • 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.

    PubMed 31189377

Questions about this trial

What is this clinical trial studying?

A study testing Interactive workshop based on community specific needs in people with Health Literacy and Communication, 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 1 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 23 Jan 2019. 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?

Change in preparation for doctor's visit (time frame: Before intervention and three months after intervention). 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 NCT03203018, which also lists 8 linked publications.

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 23 Jan 2019.

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