Cognitive Intervention to Improve Memory in Heart Failure Patients

NCT ID: NCT03035565

Last Updated: 2023-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-22

Study Completion Date

2021-09-30

Brief Summary

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Cognitive Intervention to Improve Memory in Heart Failure patients

Detailed Description

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

Conditions

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Heart Failure NYHA Class II Heart Failure NYHA Class III Heart Failure NYHA Class I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Computerized Cognitive Training Brain HQ

Computerized cognitive training intervention using Brain HQ initiated and continued 1 hour/day, 5 days/week for 8 weeks

Group Type EXPERIMENTAL

Computerized Cognitive Training with Brain HQ

Intervention Type BEHAVIORAL

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

Computerized Crossword Puzzles

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

Group Type ACTIVE_COMPARATOR

Computerized Crossword Puzzles

Intervention Type BEHAVIORAL

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

Usual Care

No computerized cognitive intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Computerized Cognitive Training with Brain HQ

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

Intervention Type BEHAVIORAL

Computerized Crossword Puzzles

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Susan Pressler

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan J Pressler, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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Indiana University Health

Indianapolis, Indiana, United States

Site Status

Methodist Hospital-Krannert Institute of Cardiology

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 29601367 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35467571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32555009 (View on PubMed)

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.

Reference Type RESULT
PMID: 34763080 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36920122 (View on PubMed)

Other Identifiers

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R01NR016116-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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