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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.
 
ClinicalTrials.gov Identifier: NCT00508716
Recruitment Status : Completed
First Posted : July 30, 2007
Results First Posted : March 25, 2015
Last Update Posted : April 15, 2015
Sponsor:
Collaborator:
Connecticut Health Foundation
Information provided by (Responsible Party):
Dorothea Wild, MD, Griffin Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Congestive Heart Failure
Intervention Behavioral: Health Literacy-Tailored Education
Enrollment 124
Recruitment Details Recruited from inpatients at a small community Hospital March 1, 2007-July 31 2010.
Pre-assignment Details  
Arm/Group Title Usual Care Tailored Low Health Literacy Intervention
Hide Arm/Group Description Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.

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.

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.

Period Title: Overall Study
Started 61 63
Completed 61 63
Not Completed 0 0
Arm/Group Title Usual Care Tailored Intervention for Patients With Low Health Literacy an Total
Hide Arm/Group Description CHF Education by usual Nurse without teach-back or Video.

Tailored Intervention for patients with low health literacy and nurse-directed teachback

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.

Total of all reporting groups
Overall Number of Baseline Participants 61 63 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 63 participants 124 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  27.9%
20
  31.7%
37
  29.8%
>=65 years
44
  72.1%
43
  68.3%
87
  70.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 63 participants 124 participants
Female
35
  57.4%
30
  47.6%
65
  52.4%
Male
26
  42.6%
33
  52.4%
59
  47.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 61 participants 63 participants 124 participants
61 63 124
1.Primary Outcome
Title Re-hospitalization or Death
Hide Description Number of participants who are re-hospitalized or die within 90 days of discharge
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Tailored Low Health Literacy Intervention
Hide Arm/Group Description:
Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.

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.

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.

Overall Number of Participants Analyzed 61 63
Measure Type: Number
Unit of Measure: participants
48 48
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Usual Care Teilored Intervention
Hide Arm/Group Description Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.

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.

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.

All-Cause Mortality
Usual Care Teilored Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Usual Care Teilored Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/63 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Usual Care Teilored Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/63 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Dorothea Wild
Organization: Griffin Hospital
Phone: 203 7327327
EMail: dwild@griffinhealth.org
Layout table for additonal information
Responsible Party: Dorothea Wild, MD, Griffin Hospital
ClinicalTrials.gov Identifier: NCT00508716    
Other Study ID Numbers: 2007-03
First Submitted: July 26, 2007
First Posted: July 30, 2007
Results First Submitted: March 15, 2015
Results First Posted: March 25, 2015
Last Update Posted: April 15, 2015