Cognitive Intervention to Improve Memory in Heart Failure Patients

Heart Failure NYHA Class III Clinical Trial

— Memoir-HF  

Official title:

Cognitive Intervention to Improve Memory in Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03035565
• Other study ID #: R01NR016116-01A1
• Status: Completed
• Phase: N/A
• Start date: February 22, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cognitive Intervention to Improve Memory in Heart Failure patients

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: September 30, 2021
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Indiana University Health	Indianapolis	Indiana
United States	Methodist Hospital-Krannert Institute of Cardiology	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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):519-5 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognitive Intervention to Improve Memory in Heart Failure Patients - Supplement	Risk of amnestic mild cognitive impairment, Alzheimer disease and related dementias, and memory decline across 36 months	Across 36 months
Primary	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
Primary	Change in serum brain derived neurotrophic factor ( BDNF) Level	Co-Primary Outcome	At 8 months
Secondary	Change in working memory as measured by CogState One Back Accuracy Task	Change in working memory as measured by CogState One Back Accuracy Task	At 8 months
Secondary	Change in instrumental activities of daily living as measured by Everyday Problems Test	Change in instrumental activities of daily living as measured by Everyday Problems Test	At 8 months
Secondary	Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire	Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire	At 8 months
Secondary	Cost-effectiveness of the Brain HQ training intervention as measured by calculating the Incremental cost effectiveness ratios (ICERs) using medical services costs	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