Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Health Literacy in Patients With Congestive Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Griffin Hospital.
Recruitment status was  Active, not recruiting
Connecticut Health Foundation
Information provided by (Responsible Party):
Dorothea Wild, MD, Griffin Hospital Identifier:
First received: July 26, 2007
Last updated: October 25, 2012
Last verified: October 2012

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 Intervention
Congestive Heart Failure
Behavioral: Health Literacy-Tailored Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Griffin Hospital:

Primary Outcome Measures:
  • Difference in the proportions of patients in the educational and usual care groups who are re-hospitalized or die within 90 days of discharge [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knowledge of CHF at study enrollment and following discharge by calculating a continuous change score based on the two administrations of the knowledge of CHF questionnaire [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 116
Study Start Date: March 2007
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A
Usual Care
Experimental: B
Tailored Intervention for patients with low health literacy and nurse-directed teachback
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.

  Show Detailed Description


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00508716

United States, Connecticut
Griffin Hospital
Derby, Connecticut, United States, 06418
Sponsors and Collaborators
Griffin Hospital
Connecticut Health Foundation
Principal Investigator: Dorothea M Wild, MD MPH Griffin Hospital
  More Information

No publications provided

Responsible Party: Dorothea Wild, MD, Principal Investigator, Griffin Hospital Identifier: NCT00508716     History of Changes
Other Study ID Numbers: 2007-03
Study First Received: July 26, 2007
Last Updated: October 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Griffin Hospital:
Congestive Heart Failure
Health Literacy
Health Education
Congestive Heart Failure (inpatients)

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases processed this record on March 03, 2015