Cognitive Intervention to Improve Memory in Heart Failure Patients

Not Applicable

Completed

• Conditions: Heart Failure NYHA Class III; Heart Failure NYHA Class II; Heart Failure NYHA Class I
• Interventions: Behavioral: Computerized Cognitive Training with Brain HQ; Behavioral: Computerized Crossword Puzzles

• Registration Number: NCT03035565
• Lead Sponsor: Indiana University

Brief Summary

Cognitive Intervention to Improve Memory in Heart Failure patients

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-30
• Study Start: 2017-02-22
• Primary Completion: 2020-11-06
• Study Completion: 2021-09-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Computerized Cognitive Training Brain HQ	Computerized Cognitive Training with Brain HQ	Computerized cognitive training intervention using Brain HQ initiated and continued 1 hour/day, 5 days/week for 8 weeks
Computerized Crossword Puzzles	Computerized Crossword Puzzles	General cognitive stimulation puzzles intervention initiated and continued 1 hour/day, 5 days/week for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in delayed recall memory as measured by Hopkins Verbal Learning Test	At 8 months	Change in delayed recall memory as measured by Hopkins Verbal Learning Test
Change in serum brain derived neurotrophic factor ( BDNF) Level	At 8 months	Co-Primary Outcome

Secondary Outcome Measures

Name	Time	Method
Change in working memory as measured by CogState One Back Accuracy Task	At 8 months	Change in working memory as measured by CogState One Back Accuracy Task
Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire	At 8 months	Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire
Cost-effectiveness of the Brain HQ training intervention as measured by calculating the Incremental cost effectiveness ratios (ICERs) using medical services costs	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
Change in instrumental activities of daily living as measured by Everyday Problems Test	At 8 months	Change in instrumental activities of daily living as measured by Everyday Problems Test

Trial Locations

Locations (2)

Indiana University Health; 🇺🇸 Indianapolis, Indiana, United States

Methodist Hospital-Krannert Institute of Cardiology; 🇺🇸 Indianapolis, Indiana, United States