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

February 15, 2023 updated by: Susan Pressler, Indiana University
Cognitive Intervention to Improve Memory in Heart Failure patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health
      • Indianapolis, Indiana, United States, 46202
        • Methodist Hospital-Krannert Institute of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 8 months
Change in serum brain derived neurotrophic factor ( BDNF) Level
Time Frame: At 8 months
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
Time Frame: At 8 months
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
Time Frame: At 8 months
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
Time Frame: At 8 months
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
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
At 8 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Across 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Susan J Pressler, PhD, RN, Indiana University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2017

Primary Completion (Actual)

November 6, 2020

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 26, 2017

First Posted (Estimate)

January 30, 2017

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01NR016116-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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