NCT03035565

Brief Summary

Cognitive Intervention to Improve Memory in Heart Failure patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
23 days until next milestone

Study Start

First participant enrolled

February 22, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

February 17, 2023

Status Verified

February 1, 2023

Enrollment Period

3.7 years

First QC Date

January 12, 2017

Last Update Submit

February 15, 2023

Conditions

Keywords

Heart FailureCognition in Heart Failure

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

    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

    At 8 months

Other Outcomes (1)

  • Cognitive Intervention to Improve Memory in Heart Failure Patients - Supplement

    Across 36 months

Study Arms (3)

Computerized Cognitive Training Brain HQ

EXPERIMENTAL

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 Crossword Puzzles

ACTIVE COMPARATOR

General cognitive stimulation puzzles intervention initiated and continued 1 hour/day, 5 days/week for 8 weeks

Behavioral: Computerized Crossword Puzzles

Usual Care

NO INTERVENTION

No computerized cognitive intervention

Interventions

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

Computerized Cognitive Training Brain HQ

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

Computerized Crossword Puzzles

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Indiana University Health

Indianapolis, Indiana, 46202, United States

Location

Methodist Hospital-Krannert Institute of Cardiology

Indianapolis, Indiana, 46202, United States

Location

Related Publications (5)

  • Pressler SJ, Giordani B, Titler M, Gradus-Pizlo I, Smith D, Dorsey SG, Gao S, Jung M. Design and Rationale of the Cognitive Intervention to Improve Memory in Heart Failure Patients Study. J Cardiovasc Nurs. 2018 Jul/Aug;33(4):344-355. doi: 10.1097/JCN.0000000000000463.

    PMID: 29601367BACKGROUND
  • Algashgari EY, Jung M, Von Ah D, Stewart JC, Pressler SJ. Perceived Facilitators and Barriers to Treatment Fidelity in Computerized Cognitive Training Interventions. J Cardiovasc Nurs. 2022 Apr 20. doi: 10.1097/JCN.0000000000000916. Online ahead of print.

    PMID: 35467571BACKGROUND
  • Halloway S, Jung M, Yeh AY, Liu J, McAdams E, Barley M, Dorsey SG, Pressler SJ. An Integrative Review of Brain-Derived Neurotrophic Factor and Serious Cardiovascular Conditions. Nurs Res. 2020 Sep/Oct;69(5):376-390. doi: 10.1097/NNR.0000000000000454.

    PMID: 32555009BACKGROUND
  • Pressler SJ, Jung M, Gradus-Pizlo I, Titler MG, Smith DG, Gao S, Lake KR, Burney H, Clark DG, Wierenga KL, Dorsey SG, Giordani B. Randomized Controlled Trial of a Cognitive Intervention to Improve Memory in Heart Failure. J Card Fail. 2022 Apr;28(4):519-530. doi: 10.1016/j.cardfail.2021.10.008. Epub 2021 Nov 8.

  • Smith AB, Jung M, Pressler SJ, Mocci E, Dorsey SG. Differential Gene Expression Among Patients With Heart Failure Experiencing Pain. Nurs Res. 2023 May-Jun 01;72(3):175-184. doi: 10.1097/NNR.0000000000000648. Epub 2023 Feb 26.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Susan J Pressler, PhD, RN

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 30, 2017

Study Start

February 22, 2017

Primary Completion

November 6, 2020

Study Completion

September 30, 2021

Last Updated

February 17, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Locations