Health Literacy in Patients With Congestive Heart Failure

NCT00508716 | Completed Results

• 1 other identifier: 2007-03
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure; Health Literacy; Health Education; Congestive Heart Failure (inpatients)

Outcome Measures

Primary Outcomes (1)

• Re-hospitalization or Death

  Number of participants who are re-hospitalized or die within 90 days of discharge

  90 days

Study Arms (2)

A

NO INTERVENTION

Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.

B

EXPERIMENTAL

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

Interventions

Health Literacy-Tailored Education BEHAVIORAL

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.

B

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Griffin Hospital: lead
• Connecticut Health Foundation: collaborator

Study Sites (1)

Griffin Hospital

Derby, Connecticut, 06418, United States

Location

MeSH Terms

Conditions

Heart Failure; Health Education

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Dorothea Wild
• Organization: Griffin Hospital

dwild@griffinhealth.org

203 7327327

Study Officials

• NAVITHA WODDOR, MD MPH

  Griffin Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 30, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2012
• Last Updated: April 15, 2015
• Results First Posted: March 25, 2015

Record last verified: 2015-03

Locations

US (1)