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Educational Program for Various Health Literacy Levels to Improve the Health of Individuals With Heart Failure

Primary Purpose

Heart Failure, Congestive

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Teach to Goal (TTG)
Brief Educational Intervention (BEI)
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure, Congestive focused on measuring Congestive Heart Failure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of HF
  • Currently prescribed a Loop diuretic medication
  • At least one of the following findings:

    1. Chest x-ray consistent with HF (current or past x-ray with probable or definite pulmonary edema)
    2. Reduced ejection fraction on echocardiogram (ECHO), multiple gate acquisition scan (MUGA), or cardiac catheterization (less than 50%)
    3. Left ventricular hypertrophy (LVH) or diastolic filling pattern on ECHO
    4. Elevated B-type natriuretic peptide
  • Currently experiencing New York Heart Association Class II-IV symptoms or has experienced these symptoms in the 6 months prior to study entry
  • Has a working telephone
  • Speaks English or Spanish

Exclusion Criteria:

  • Patients will be ineligible if they meet ONE the following criteria:

    1. Sight - Inability to see printed educational material well enough to utilize it
    2. Cognition - Moderate to severe dementia (If medical notes state "Severe Dementia" or as determined by administering the study's cognitive screener)
    3. Surgery -Valuvular disease rated as severe (mitral stenosis, aortic stenosis or aortic regurgitation) or valuvular surgery planned within a year (i.e., bypass, angioplasty, valve replacement, heart transplant)
    4. Terminal Illness - Possessing a terminal illness with prognosis of 1 year or less
    5. Dialysis - Currently on dialysis or anticipated to start dialysis within 1 year
    6. Oxygen Dependant - Using concentrate oxygen intermittent or continuously for COPD
    7. Management of Care - Not able to control medications
    8. Other Studies -Patient enrolled (past or present) in another study where intervention status would interfere with pure outcome of this or other study

Sites / Locations

  • University of California - Los Angeles (UCLA)
  • University of California at San Francisco, San Francisco General Hospital
  • Northwestern Medical Faculty Foundation Clinics & Northwestern Memorial Hospital Chicago
  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Participants will receive a 1-hour education session about CHF, symptom recognition, diet, exercise, and daily check ups.

Participants will receive a 1-hour education session about CHF, symptom recognition, diet, exercise, and daily check ups, as well as additional information on diuretic self adjustment. This group will then get several follow-up phone calls over the course of the year to reinforce these topics and help them master the knowledge and encourage behavior and lifestyle changes to align with these topics.

Outcomes

Primary Outcome Measures

All cause hospitalization
All cause mortality

Secondary Outcome Measures

Heart failure quality-of-life
Heart failure-related hospitalizations
Difference between groups for adoption of appropriate self-management knowledge and behaviors

Full Information

First Posted
September 20, 2006
Last Updated
May 1, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00378950
Brief Title
Educational Program for Various Health Literacy Levels to Improve the Health of Individuals With Heart Failure
Official Title
Health Literacy and Self-Management in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Heart failure (HF) affects 5 million people in the United States. Health literacy, which is the ability to read and comprehend important medical information, plays an important role in the health of individuals with HF. This study will evaluate the effectiveness of an educational program developed for various levels of health literacy at improving medical outcomes and quality of life in individuals with HF.
Detailed Description
HF is a complicated disease that often requires individuals to carefully monitor their condition. Individuals with HF must follow strict medication regimens, adhere to diet and exercise recommendations, and closely monitor symptoms and changes in weight. Individuals with low health literacy skills may have a harder time comprehending medication dosing instructions, educational materials, and the overall complexity of managing HF than individuals with higher health literacy skills. Programs that focus on building self-care skills have been proven to reduce the rate of hospitalizations among individuals with HF; only one study, however, has specifically examined the importance of health literacy in the effectiveness of these programs. Teach to Goal (TTG), a program that focuses on developing self-care skills while incorporating medical information for various health literacy levels, may improve medical outcomes in individuals with HF. The purpose of this study is to evaluate the effectiveness of TTG at improving hospitalization and death rates, quality of life, and self-care behaviors among individuals with HF. This 1-year study will enroll individuals with HF. Eligible participants will attend a baseline study visit and complete survey questionnaires. Participants will then be randomly assigned to either TTG or a control group. The TTG group will partake in a 30- to 60-minute educational session, which will focus on improving self-care skills. They will also receive literacy-sensitive printed materials about monitoring body weight and swelling in the legs, medication administration, and a sodium reduction and exercise plan. Control group participants will partake in a shorter educational session and will receive fewer printed materials. All participants will be provided with a digital scale to self-monitor their weight at home. The TTG group will receive follow-up phone calls on Days 3, 7, 14, 21, and 28, during which study staff will assess participants' progress and will provide additional support and training as necessary. Both groups will receive phone calls at Months 1, 6, and 12. During these calls, number of hospitalizations, quality of life, and changes in self-care behavior and knowledge will be evaluated, but participants will not receive any additional training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
Congestive Heart Failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
605 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Participants will receive a 1-hour education session about CHF, symptom recognition, diet, exercise, and daily check ups.
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will receive a 1-hour education session about CHF, symptom recognition, diet, exercise, and daily check ups, as well as additional information on diuretic self adjustment. This group will then get several follow-up phone calls over the course of the year to reinforce these topics and help them master the knowledge and encourage behavior and lifestyle changes to align with these topics.
Intervention Type
Behavioral
Intervention Name(s)
Teach to Goal (TTG)
Other Intervention Name(s)
TTG
Intervention Description
The TTG program includes the Brief Educational Intervention (BEI) educational intervention, as well as education about diuretic self adjustment. In addition, follow-up phone calls are given to the TTG group to further reinforce the initial training and provide further training so participants will master the task.
Intervention Type
Behavioral
Intervention Name(s)
Brief Educational Intervention (BEI)
Other Intervention Name(s)
BEI
Intervention Description
The BEI is a one hour educational session on CHF, symptom recognition, diet, exercise, and daily checkups.
Primary Outcome Measure Information:
Title
All cause hospitalization
Time Frame
Measured at 12 months
Title
All cause mortality
Time Frame
Measured at 12 months
Secondary Outcome Measure Information:
Title
Heart failure quality-of-life
Time Frame
Measured at 1, 6, 12 months
Title
Heart failure-related hospitalizations
Time Frame
Measured at 12 months
Title
Difference between groups for adoption of appropriate self-management knowledge and behaviors
Time Frame
Measured at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of HF Currently prescribed a Loop diuretic medication At least one of the following findings: Chest x-ray consistent with HF (current or past x-ray with probable or definite pulmonary edema) Reduced ejection fraction on echocardiogram (ECHO), multiple gate acquisition scan (MUGA), or cardiac catheterization (less than 50%) Left ventricular hypertrophy (LVH) or diastolic filling pattern on ECHO Elevated B-type natriuretic peptide Currently experiencing New York Heart Association Class II-IV symptoms or has experienced these symptoms in the 6 months prior to study entry Has a working telephone Speaks English or Spanish Exclusion Criteria: Patients will be ineligible if they meet ONE the following criteria: Sight - Inability to see printed educational material well enough to utilize it Cognition - Moderate to severe dementia (If medical notes state "Severe Dementia" or as determined by administering the study's cognitive screener) Surgery -Valuvular disease rated as severe (mitral stenosis, aortic stenosis or aortic regurgitation) or valuvular surgery planned within a year (i.e., bypass, angioplasty, valve replacement, heart transplant) Terminal Illness - Possessing a terminal illness with prognosis of 1 year or less Dialysis - Currently on dialysis or anticipated to start dialysis within 1 year Oxygen Dependant - Using concentrate oxygen intermittent or continuously for COPD Management of Care - Not able to control medications Other Studies -Patient enrolled (past or present) in another study where intervention status would interfere with pure outcome of this or other study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Pignone, MD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California - Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University of California at San Francisco, San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Northwestern Medical Faculty Foundation Clinics & Northwestern Memorial Hospital Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19519904
Citation
DeWalt DA, Broucksou KA, Hawk V, Baker DW, Schillinger D, Ruo B, Bibbins-Domingo K, Holmes M, Weinberger M, Macabasco-O'Connell A, Pignone M. Comparison of a one-time educational intervention to a teach-to-goal educational intervention for self-management of heart failure: design of a randomized controlled trial. BMC Health Serv Res. 2009 Jun 11;9:99. doi: 10.1186/1472-6963-9-99.
Results Reference
background
PubMed Identifier
21951244
Citation
Baker DW, DeWalt DA, Schillinger D, Hawk V, Ruo B, Bibbins-Domingo K, Weinberger M, Macabasco-O'Connell A, Pignone M. "Teach to goal": theory and design principles of an intervention to improve heart failure self-management skills of patients with low health literacy. J Health Commun. 2011;16 Suppl 3(Suppl 3):73-88. doi: 10.1080/10810730.2011.604379.
Results Reference
background
PubMed Identifier
21962415
Citation
Baker DW, Dewalt DA, Schillinger D, Hawk V, Ruo B, Bibbins-Domingo K, Weinberger M, Macabasco-O'Connell A, Grady KL, Holmes GM, Erman B, Broucksou KA, Pignone M. The effect of progressive, reinforcing telephone education and counseling versus brief educational intervention on knowledge, self-care behaviors and heart failure symptoms. J Card Fail. 2011 Oct;17(10):789-96. doi: 10.1016/j.cardfail.2011.06.374. Epub 2011 Jul 23.
Results Reference
result
PubMed Identifier
21369770
Citation
Macabasco-O'Connell A, DeWalt DA, Broucksou KA, Hawk V, Baker DW, Schillinger D, Ruo B, Bibbins-Domingo K, Holmes GM, Erman B, Weinberger M, Pignone M. Relationship between literacy, knowledge, self-care behaviors, and heart failure-related quality of life among patients with heart failure. J Gen Intern Med. 2011 Sep;26(9):979-86. doi: 10.1007/s11606-011-1668-y. Epub 2011 Mar 3.
Results Reference
result
PubMed Identifier
22572916
Citation
DeWalt DA, Schillinger D, Ruo B, Bibbins-Domingo K, Baker DW, Holmes GM, Weinberger M, Macabasco-O'Connell A, Broucksou K, Hawk V, Grady KL, Erman B, Sueta CA, Chang PP, Cene CW, Wu JR, Jones CD, Pignone M. Multisite randomized trial of a single-session versus multisession literacy-sensitive self-care intervention for patients with heart failure. Circulation. 2012 Jun 12;125(23):2854-62. doi: 10.1161/CIRCULATIONAHA.111.081745. Epub 2012 May 9.
Results Reference
derived

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Educational Program for Various Health Literacy Levels to Improve the Health of Individuals With Heart Failure

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