Cognitive Intervention to Improve Memory in Heart Failure Patients

Study Overview
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Brief Summary
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Cognitive Intervention to Improve Memory in Heart Failure patients

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

Official Title
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Cognitive Intervention to Improve Memory in Heart Failure Patients

Conditions
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Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class I

Intervention / Treatment
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* Behavioral: Computerized Cognitive Training with Brain HQ
* Behavioral: Computerized Crossword Puzzles


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computerized Cognitive Training Brain HQ<br>Computerized cognitive training intervention using Brain HQ initiated and continued 1 hour/day, 5 days/week for 8 weeks | Behavioral: Computerized Cognitive Training with Brain HQ<br>* Computerized Cognitive Training Brain HQ activities initiated and continued 1 hour/day, 5 days/week for 8 weeks<br>|
| Active Comparator: Computerized Crossword Puzzles<br>General cognitive stimulation puzzles intervention initiated and continued 1 hour/day, 5 days/week for 8 weeks | Behavioral: Computerized Crossword Puzzles<br>* Computerized Crossword Puzzles activities initiated and continued 1 hour/day, 5 days/week for 8 weeks<br>|
| No Intervention: Usual Care<br>No computerized cognitive intervention | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in working memory as measured by CogState One Back Accuracy Task | Change in working memory as measured by CogState One Back Accuracy Task | At 8 months | 
| Change in instrumental activities of daily living as measured by Everyday Problems Test | Change in instrumental activities of daily living as measured by Everyday Problems Test | At 8 months | 
| Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire | Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Cognition in Heart Failure