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

NCT00378950 | Completed DMC

• 2 other identifiers: 439R01HL081257-01A1
• Study Type: interventional
• Target: 605
• Locations: 1 country
• Sites: 4

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.

Conditions

Heart Failure, Congestive

Keywords

Congestive Heart Failure

Outcome Measures

Primary Outcomes (2)

• All cause hospitalization

  Measured at 12 months

• All cause mortality

  Measured at 12 months

Secondary Outcomes (3)

• Heart failure quality-of-life

  Measured at 1, 6, 12 months

• Heart failure-related hospitalizations

  Measured at 12 months

• Difference between groups for adoption of appropriate self-management knowledge and behaviors

  Measured at 12 months

Study Arms (2)

1

ACTIVE COMPARATOR

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

Behavioral: Brief Educational Intervention (BEI)

2

EXPERIMENTAL

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.

Behavioral: Teach to Goal (TTG)

Interventions

Teach to Goal (TTG) BEHAVIORAL

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.

Also known as: TTG

2

Brief Educational Intervention (BEI) BEHAVIORAL

The BEI is a one hour educational session on CHF, symptom recognition, diet, exercise, and daily checkups.

Also known as: BEI

1

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

University of California - Los Angeles (UCLA)

Los Angeles, California, 90024, United States

Location

University of California at San Francisco, San Francisco General Hospital

San Francisco, California, 94143, United States

Location

Northwestern Medical Faculty Foundation Clinics & Northwestern Memorial Hospital Chicago

Chicago, Illinois, 60611, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (5)

• 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.

  PMID: 19519904 BACKGROUND

• 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.

  PMID: 21951244 BACKGROUND

• 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.

  PMID: 21962415 RESULT

• 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.

  PMID: 21369770 RESULT

• 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.

  PMID: 22572916 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Mike Pignone, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2006
• First Posted: September 21, 2006
• Study Start: March 1, 2007
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: May 4, 2017

Record last verified: 2016-05

Locations

US (4)