Back to resultsCognitive Intervention to Improve Memory in Heart Failure Patients (Memoir-HF)
Primary Purpose
Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class I
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Cognitive Training with Brain HQ
Computerized Crossword Puzzles
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure NYHA Class II focused on measuring Heart Failure, Cognition in Heart Failure
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.
Sites / Locations
- Indiana University Health
- Methodist Hospital-Krannert Institute of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Computerized Cognitive Training Brain HQ
Computerized Crossword Puzzles
Usual Care
Arm Description
Computerized cognitive training intervention using Brain HQ initiated and continued 1 hour/day, 5 days/week for 8 weeks
General cognitive stimulation puzzles intervention initiated and continued 1 hour/day, 5 days/week for 8 weeks
No computerized cognitive intervention
Outcomes
Primary Outcome Measures
Change in delayed recall memory as measured by Hopkins Verbal Learning Test
Change in delayed recall memory as measured by Hopkins Verbal Learning Test
Change in serum brain derived neurotrophic factor ( BDNF) Level
Co-Primary Outcome
Secondary Outcome Measures
Change in working memory as measured by CogState One Back Accuracy Task
Change in working memory as measured by CogState One Back Accuracy Task
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03035565
Brief Title
Cognitive Intervention to Improve Memory in Heart Failure Patients
Acronym
Memoir-HF
Official Title
Cognitive Intervention to Improve Memory in Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
November 6, 2020 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cognitive Intervention to Improve Memory in Heart Failure patients
Detailed Description
A three arm randomized controlled trial of 276 heart failure patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure NYHA Class II, Heart Failure NYHA Class III, Heart Failure NYHA Class I
Keywords
Heart Failure, Cognition in Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
276 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computerized Cognitive Training Brain HQ
Arm Type
Experimental
Arm Description
Computerized cognitive training intervention using Brain HQ initiated and continued 1 hour/day, 5 days/week for 8 weeks
Arm Title
Computerized Crossword Puzzles
Arm Type
Active Comparator
Arm Description
General cognitive stimulation puzzles intervention initiated and continued 1 hour/day, 5 days/week for 8 weeks
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
No computerized cognitive intervention
Intervention Type
Behavioral
Intervention Name(s)
Computerized Cognitive Training with Brain HQ
Intervention Description
Computerized Cognitive Training Brain HQ activities initiated and continued 1 hour/day, 5 days/week for 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Computerized Crossword Puzzles
Intervention Description
Computerized Crossword Puzzles activities initiated and continued 1 hour/day, 5 days/week for 8 weeks
Primary Outcome Measure Information:
Title
Change in delayed recall memory as measured by Hopkins Verbal Learning Test
Description
Change in delayed recall memory as measured by Hopkins Verbal Learning Test
Time Frame
At 8 months
Title
Change in serum brain derived neurotrophic factor ( BDNF) Level
Description
Co-Primary Outcome
Time Frame
At 8 months
Secondary Outcome Measure Information:
Title
Change in working memory as measured by CogState One Back Accuracy Task
Description
Change in working memory as measured by CogState One Back Accuracy Task
Time Frame
At 8 months
Title
Change in instrumental activities of daily living as measured by Everyday Problems Test
Description
Change in instrumental activities of daily living as measured by Everyday Problems Test
Time Frame
At 8 months
Title
Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire
Description
Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire
Time Frame
At 8 months
Title
Cost-effectiveness of the Brain HQ training intervention as measured by calculating the Incremental cost effectiveness ratios (ICERs) using medical services costs
Description
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
Other Pre-specified Outcome Measures:
Title
Cognitive Intervention to Improve Memory in Heart Failure Patients - Supplement
Description
Risk of amnestic mild cognitive impairment, Alzheimer disease and related dementias, and memory decline across 36 months
Time Frame
Across 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan J Pressler, PhD, RN
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Methodist Hospital-Krannert Institute of Cardiology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
29601367
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.
Results Reference
background
PubMed Identifier
35467571
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.
Results Reference
background
PubMed Identifier
32555009
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.
Results Reference
background
PubMed Identifier
34763080
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.
Results Reference
result
Learn more about this trial
Cognitive Intervention to Improve Memory in Heart Failure Patients
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