Working… Menu

Health Literacy in Patients With Congestive Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00508716
Recruitment Status : Completed
First Posted : July 30, 2007
Results First Posted : March 25, 2015
Last Update Posted : April 15, 2015
Connecticut Health Foundation
Information provided by (Responsible Party):
Dorothea Wild, MD, Griffin Hospital

Brief Summary:

The primary aim of this project is to test the efficacy of an inpatient congestive heart failure (CHF) educational intervention compared with usual care among inpatients at Griffin Hospital, who are largely drawn from the population of the Naugatuck Valley in Connecticut.

The educational intervention will utilize:

  • written educational materials suitable for patients with low health literacy - alternatives to written materials (e.g., video- and audiotapes) that may more effectively communicate health information to elderly patients and those with low health literacy
  • a one-on-one educational session with a nurse patient educator. The educational session will use as its framework guidelines provided by the America Medical Association (AMA) to improve communication between healthcare providers and low health literacy patients. The investigators hypothesize that CHF patients who receive this educational intervention will have fewer hospital readmissions or deaths than the usual care group. The investigators further hypothesize that patients with low health literacy will derive more benefit from the intervention than patients with higher literacy.

The secondary aims of the project are to:

  • assess whether patients in the education and usual care groups differ on post-discharge CHF knowledge and on satisfaction with hospital care. Compared with usual care, the investigators hypothesize that CHF patients who receive the educational intervention will have better knowledge of CHF and will be more satisfied with the care they received in the hospital.

The potential impact of the proposed project may be to increase disease knowledge and health literacy, and improve adherence to CHF treatments. This, in turn, may contribute to improved medical outcomes and reduced hospital readmissions for CHF patients. In addition, if this preliminary study provides evidence of a promising educational intervention suitable for patients with low health literacy, th investigators will endeavor to test the intervention in ethnically diverse populations throughout Connecticut.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Behavioral: Health Literacy-Tailored Education Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized-Controlled Trial of a Health Literacy Tailored Educational Intervention for Hospitalized Congestive Heart Failure Patients
Study Start Date : March 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: A
Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
Experimental: B
Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for "teachback after Intervention". This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.
Behavioral: Health Literacy-Tailored Education
Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials.

Primary Outcome Measures :
  1. Re-hospitalization or Death [ Time Frame: 90 days ]
    Number of participants who are re-hospitalized or die within 90 days of discharge

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Eligible consecutive patients aged 50 years and over admitted with a primary diagnosis of CHF at Griffin Hospital will be invited to participate regardless of age, gender, race, or education level.
  • Because dietary and medication non-compliance affect patients with both systolic and diastolic heart failure, the investigators will include patients with both of these conditions, regardless of their ejection fraction.

Exclusion Criteria:

  • The investigators will exclude patients with clinical conditions and communication barriers that would limit their ability to participate in and/or benefit from this educational intervention.
  • The investigators will also exclude patients whose planned discharge is to another hospital or to a structured setting in which medical personnel are responsible for their care (e.g., a skilled nursing facility), thus limiting their ability to implement a largely self-directed self-care regimen upon leaving the hospital.
  • In addition, the investigators will exclude any patient who does not have a telephone and cannot, therefore, be contacted to obtain post-discharge follow-up data.

Specific exclusion criteria include:

  • A diagnosis of dementia or other severe mental disorder (e.g., acute delirium, psychosis)
  • Clinical instability or need for transfer to another hospital for acute intervention (e.g., experiencing cardiogenic shock, or needing valve surgery or acute coronary intervention)
  • Terminal illness or intubation
  • Moderate to severe uncorrected vision or hearing problems
  • Inability to speak English or to provide informed consent
  • Lack of access to a telephone
  • Planned discharge to a structured facility (e.g., skilled nursing facility, intermediate care facility)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00508716

Layout table for location information
United States, Connecticut
Griffin Hospital
Derby, Connecticut, United States, 06418
Sponsors and Collaborators
Griffin Hospital
Connecticut Health Foundation
Layout table for investigator information
Principal Investigator: NAVITHA WODDOR, MD MPH Griffin Hospital
Layout table for additonal information
Responsible Party: Dorothea Wild, MD, Principal Investigator, Griffin Hospital Identifier: NCT00508716    
Other Study ID Numbers: 2007-03
First Posted: July 30, 2007    Key Record Dates
Results First Posted: March 25, 2015
Last Update Posted: April 15, 2015
Last Verified: March 2015
Keywords provided by Dorothea Wild, MD, Griffin Hospital:
Congestive Heart Failure
Health Literacy
Health Education
Congestive Heart Failure (inpatients)
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases