Clinical trial NCT03035565: Cognitive Intervention to Improve Memory in Heart Failure Patients
Official title: Cognitive Intervention to Improve Memory in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure NYHA Class II
Heart Failure NYHA Class III
Heart Failure NYHA Class I
Keywords: Heart Failure
Cognition in Heart Failure
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 276
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

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

Eligibility 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

Supplement Eligibility: First 144 patients randomized in the parent trial.

Primary outcomes:
measure: Change in delayed recall memory as measured by Hopkins Verbal Learning Test
timeFrame: At 8 months
measure: Change in serum brain derived neurotrophic factor ( BDNF) Level
timeFrame: At 8 months
Secondary outcomes:
measure: Change in working memory as measured by CogState One Back Accuracy Task
timeFrame: At 8 months
measure: Change in instrumental activities of daily living as measured by Everyday Problems Test
timeFrame: At 8 months
measure: Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire
timeFrame: At 8 months
measure: Cost-effectiveness of the Brain HQ training intervention as measured by calculating the Incremental cost effectiveness ratios (ICERs) using medical services costs
timeFrame: At 8 months
Other outcomes:
measure: Cognitive Intervention to Improve Memory in Heart Failure Patients - Supplement
timeFrame: Across 36 months
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Indianapolis
country: United States
facility: Methodist Hospital-Krannert Institute of Cardiology
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Susan J Pressler, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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):519-530. doi: 10.1016/j.cardfail.2021.10.008. Epub 2021 Nov 8.