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Cognitive Intervention to Improve Memory in Heart Failure Patients (Memoir-HF)

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ClinicalTrials.gov Identifier: NCT03035565
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
Susan Pressler, Indiana University

Brief Summary:
Cognitive Intervention to Improve Memory in Heart Failure patients

Condition or disease Intervention/treatment Phase
Heart Failure NYHA Class II Heart Failure NYHA Class III Heart Failure NYHA Class I Behavioral: Computerized Cognitive Training with Brain HQ Behavioral: Computerized Crossword Puzzles Not Applicable

Detailed Description:
A three arm randomized controlled trial of 264 heart failure patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Intervention to Improve Memory in Heart Failure Patients
Actual Study Start Date : February 22, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


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

Active Comparator: Computerized Crossword Puzzles
General cognitive stimulation puzzles intervention initiated and continued 1 hour/day, 5 days/week for 8 weeks
Behavioral: Computerized Crossword Puzzles
Computerized Crossword Puzzles activities initiated and continued 1 hour/day, 5 days/week for 8 weeks

No Intervention: Usual Care
No computerized cognitive intervention



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035565


Contacts
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Contact: Susan J Pressler, Phd, RN 317-274-4080 sjpress@iu.edu

Locations
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United States, Indiana
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Indiana University Health         
Methodist Hospital-Krannert Institute of Cardiology Recruiting
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Susan J Pressler, PhD, RN Indiana University School of Medicine

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Responsible Party: Susan Pressler, Principal Investigator, Indiana University
ClinicalTrials.gov Identifier: NCT03035565     History of Changes
Other Study ID Numbers: R01NR016116-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Susan Pressler, Indiana University:
Heart Failure
Cognition in Heart Failure

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases