Cognitive Intervention to Improve Memory in Heart Failure Patients

N/ACompletedNCT03035565

Indiana University276 enrolled

Overview

Cognitive Intervention to Improve Memory in Heart Failure patients

A three arm randomized controlled trial of 276 heart failure patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

276

Conditions

Heart Failure NYHA Class II Heart Failure NYHA Class III Heart Failure NYHA Class I

Interventions

Computerized Cognitive Training with Brain HQBEHAVIORAL

Computerized Cognitive Training Brain HQ activities initiated and continued 1 hour/day, 5 days/week for 8 weeks

Computerized Crossword PuzzlesBEHAVIORAL

Computerized Crossword Puzzles activities initiated and continued 1 hour/day, 5 days/week for 8 weeks

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * At least 21 years of age * Understands English * Has access to a telephone * Hears normal conversation * For patients with hearing aids, able to wear and hear through headsets * Diagnosis of chronic heart failure, stage C, NYHA I, II or III * Receiving guideline derived medical therapy * Heart failure validated by echocardiography or other method in past 2 years * Able to read a computer screen with or without glasses or lenses Exclusion Criteria: * History of drug or alcohol abuse or major psychiatric diagnosis present before the heart failure diagnosis * Alzheimer or other dementia diagnosis or central nervous system degenerative disorder * Terminal cancer * Patients with baseline Montreal Cognitive Assessment (MoCA) score of less than 19 Supplement Eligibility: First 144 patients randomized in the parent trial.

Locations (2)

Indiana University Health

Indianapolis, Indiana, United States

Methodist Hospital-Krannert Institute of Cardiology

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Change in delayed recall memory as measured by Hopkins Verbal Learning Test

Time frame: At 8 months

Change in serum brain derived neurotrophic factor ( BDNF) Level

Co-Primary Outcome

Time frame: At 8 months

Secondary Outcomes

Change in working memory as measured by CogState One Back Accuracy Task

Time frame: At 8 months

Change in instrumental activities of daily living as measured by Everyday Problems Test

Time frame: At 8 months

Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire

Time frame: At 8 months

Cost-effectiveness of the Brain HQ training intervention as measured by calculating the Incremental cost effectiveness ratios (ICERs) using medical services costs

Time frame: At 8 months

Data from ClinicalTrials.gov

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