<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03035565</url>
  </required_header>
  <id_info>
    <org_study_id>R01NR016116-01A1</org_study_id>
    <nct_id>NCT03035565</nct_id>
  </id_info>
  <brief_title>Cognitive Intervention to Improve Memory in Heart Failure Patients</brief_title>
  <acronym>Memoir-HF</acronym>
  <official_title>Cognitive Intervention to Improve Memory in Heart Failure Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cognitive Intervention to Improve Memory in Heart Failure patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A three arm randomized controlled trial of 276 heart failure patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2017</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 6, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in delayed recall memory as measured by Hopkins Verbal Learning Test</measure>
    <time_frame>At 8 months</time_frame>
    <description>Change in delayed recall memory as measured by Hopkins Verbal Learning Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in serum brain derived neurotrophic factor ( BDNF) Level</measure>
    <time_frame>At 8 months</time_frame>
    <description>Co-Primary Outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in working memory as measured by CogState One Back Accuracy Task</measure>
    <time_frame>At 8 months</time_frame>
    <description>Change in working memory as measured by CogState One Back Accuracy Task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in instrumental activities of daily living as measured by Everyday Problems Test</measure>
    <time_frame>At 8 months</time_frame>
    <description>Change in instrumental activities of daily living as measured by Everyday Problems Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire</measure>
    <time_frame>At 8 months</time_frame>
    <description>Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness of the Brain HQ training intervention as measured by calculating the Incremental cost effectiveness ratios (ICERs) using medical services costs</measure>
    <time_frame>At 8 months</time_frame>
    <description>Cost-effectiveness of the Brain HQ training intervention as measured by calculating the Incremental cost effectiveness ratios (ICERs) using medical services costs</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cognitive Intervention to Improve Memory in Heart Failure Patients - Supplement</measure>
    <time_frame>Across 36 months</time_frame>
    <description>Risk of amnestic mild cognitive impairment, Alzheimer disease and related dementias, and memory decline across 36 months</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">276</enrollment>
  <condition>Heart Failure NYHA Class II</condition>
  <condition>Heart Failure NYHA Class III</condition>
  <condition>Heart Failure NYHA Class I</condition>
  <arm_group>
    <arm_group_label>Computerized Cognitive Training Brain HQ</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Computerized cognitive training intervention using Brain HQ initiated and continued 1 hour/day, 5 days/week for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Computerized Crossword Puzzles</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>General cognitive stimulation puzzles intervention initiated and continued 1 hour/day, 5 days/week for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No computerized cognitive intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computerized Cognitive Training with Brain HQ</intervention_name>
    <description>Computerized Cognitive Training Brain HQ activities initiated and continued 1 hour/day, 5 days/week for 8 weeks</description>
    <arm_group_label>Computerized Cognitive Training Brain HQ</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computerized Crossword Puzzles</intervention_name>
    <description>Computerized Crossword Puzzles activities initiated and continued 1 hour/day, 5 days/week for 8 weeks</description>
    <arm_group_label>Computerized Crossword Puzzles</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 21 years of age&#xD;
&#xD;
          -  Understands English&#xD;
&#xD;
          -  Has access to a telephone&#xD;
&#xD;
          -  Hears normal conversation&#xD;
&#xD;
          -  For patients with hearing aids, able to wear and hear through headsets&#xD;
&#xD;
          -  Diagnosis of chronic heart failure, stage C, NYHA I, II or III&#xD;
&#xD;
          -  Receiving guideline derived medical therapy&#xD;
&#xD;
          -  Heart failure validated by echocardiography or other method in past 2 years&#xD;
&#xD;
          -  Able to read a computer screen with or without glasses or lenses&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of drug or alcohol abuse or major psychiatric diagnosis present before the&#xD;
             heart failure diagnosis&#xD;
&#xD;
          -  Alzheimer or other dementia diagnosis or central nervous system degenerative disorder&#xD;
&#xD;
          -  Terminal cancer&#xD;
&#xD;
          -  Patients with baseline Montreal Cognitive Assessment (MoCA) score of less than 19&#xD;
&#xD;
        Supplement Eligibility: First 144 patients randomized in the parent trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan J Pressler, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University Health</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Hospital-Krannert Institute of Cardiology</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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>
    <PMID>29601367</PMID>
  </reference>
  <reference>
    <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>
    <PMID>35467571</PMID>
  </reference>
  <reference>
    <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>
    <PMID>32555009</PMID>
  </reference>
  <results_reference>
    <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.</citation>
    <PMID>34763080</PMID>
  </results_reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>February 15, 2023</last_update_submitted>
  <last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Susan Pressler</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Heart Failure</keyword>
  <keyword>Cognition in Heart Failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03035565
org study id: R01NR016116-01A1
nct id: NCT03035565
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cognitive Intervention to Improve Memory in Heart Failure patients
A three arm randomized controlled trial of 276 heart failure patients.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in delayed recall memory as measured by Hopkins Verbal Learning Test
time frame: At 8 months
description: Change in delayed recall memory as measured by Hopkins Verbal Learning Test
measure: Change in serum brain derived neurotrophic factor ( BDNF) Level
time frame: At 8 months
description: Co-Primary Outcome
measure: Change in working memory as measured by CogState One Back Accuracy Task
time frame: At 8 months
description: Change in working memory as measured by CogState One Back Accuracy Task
measure: Change in instrumental activities of daily living as measured by Everyday Problems Test
time frame: At 8 months
description: Change in instrumental activities of daily living as measured by Everyday Problems Test
measure: Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire
time frame: At 8 months
description: Change in health-related quality of life as measured by Minnesota Living with Heart Failure Questionnaire
measure: 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
description: Cost-effectiveness of the Brain HQ training intervention as measured by calculating the Incremental cost effectiveness ratios (ICERs) using medical services costs
measure: Cognitive Intervention to Improve Memory in Heart Failure Patients - Supplement
time frame: Across 36 months
description: Risk of amnestic mild cognitive impairment, Alzheimer disease and related dementias, and memory decline across 36 months
arm group label: Computerized Cognitive Training Brain HQ
arm group type: Experimental
description: Computerized cognitive training intervention using Brain HQ initiated and continued 1 hour/day, 5 days/week for 8 weeks
arm group label: Computerized Crossword Puzzles
arm group type: Active Comparator
description: General cognitive stimulation puzzles intervention initiated and continued 1 hour/day, 5 days/week for 8 weeks
arm group label: Usual Care
arm group type: No Intervention
description: No computerized cognitive intervention
intervention type: Behavioral
intervention name: Computerized Cognitive Training with Brain HQ
description: Computerized Cognitive Training Brain HQ activities initiated and continued 1 hour/day, 5 days/week for 8 weeks
arm group label: Computerized Cognitive Training Brain HQ
intervention type: Behavioral
intervention name: Computerized Crossword Puzzles
description: Computerized Crossword Puzzles activities initiated and continued 1 hour/day, 5 days/week for 8 weeks
arm group label: Computerized Crossword Puzzles
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Susan J Pressler, PhD, RN
role: Principal Investigator
affiliation: Indiana University School of Medicine
facility: 
facility: 
country: United States
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.
PMID: 29601367
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.
PMID: 35467571
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.
PMID: 32555009
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.
PMID: 34763080
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Susan Pressler
investigator title: Principal Investigator
mesh term: Heart Failure
sharing ipd: Yes