Heart Failure NYHA Class I, Heart Failure NYHA Class II, Heart Failure NYHA Class III
Conditions
Keywords
Heart Failure, Cognition in Heart Failure
Brief summary
Cognitive Intervention to Improve Memory in Heart Failure patients
Detailed description
A three arm randomized controlled trial of 276 heart failure patients.
Interventions
BEHAVIORALComputerized Cognitive Training with Brain HQ
Computerized Cognitive Training Brain HQ activities initiated and continued 1 hour/day, 5 days/week for 8 weeks
BEHAVIORALComputerized Crossword Puzzles
Computerized Crossword Puzzles activities initiated and continued 1 hour/day, 5 days/week for 8 weeks
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum brain derived neurotrophic factor ( BDNF) Level | At 8 months | Co-Primary Outcome |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Intervention to Improve Memory in Heart Failure Patients - Supplement | Across 36 months | Risk of amnestic mild cognitive impairment, Alzheimer disease and related dementias, and memory decline across 36 months |
Countries
United States
Outcome results
None listed