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OpenTrials
Completed

NCT Number: NCT03035565

Cognitive Intervention to Improve Memory in Heart Failure Patients

Cognitive Intervention to Improve Memory in Heart Failure patients

Completed

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Key information

Conditions

Heart Failure NYHA Class II Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure NYHA Class I Heart Failure NYHA Class III

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health, Indianapolis, Indiana, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computerized Cognitive Training with Brain HQ

Behavioral

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

Computerized Crossword Puzzles

Behavioral

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

Primary outcomes

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

    Time frame: At 8 months

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

  2. Change in serum brain derived neurotrophic factor ( BDNF) Level

    Time frame: At 8 months

    Co-Primary Outcome

Secondary outcomes

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

    Time frame: At 8 months

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

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

    Time frame: At 8 months

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

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

    Time frame: At 8 months

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

  4. 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

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

Other outcomes

  1. Cognitive Intervention to Improve Memory in Heart Failure Patients - Supplement

    Time frame: Across 36 months

    Risk of amnestic mild cognitive impairment, Alzheimer disease and related dementias, and memory decline across 36 months

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Acronym: Memoir-HF

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jan 30, 2017
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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