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Cognitive Training for Older Caregivers (CTC)

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ClinicalTrials.gov Identifier: NCT03036423
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : November 12, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Kathi Heffner, University of Rochester

Brief Summary:
The purpose of this study is to test whether certain brain training activities can promote cognitive, emotional, and physical health in caregivers of a loved one with dementia. Numerous studies show that family dementia caregiving can be stressful, and can increase mental and physical health risks. This study aims to understand how to reduce those risks.

Condition or disease Intervention/treatment Phase
Life Stress Behavioral: Online video education Behavioral: Computerized mental exercises Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cognitive Training to Protect Immune Systems of Older Caregivers
Study Start Date : September 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Active Comparator: Online video education
Participants will have computer access to a library of videos, including various lectures and demonstrations of interest, from which to select and view.
Behavioral: Online video education
Active Comparator: Computerized mental exercises
Participants will use a computer to do a variety of activities which are customizable to their own abilities and progress.
Behavioral: Computerized mental exercises



Primary Outcome Measures :
  1. Useful Field of View test performance at 12 months after the intervention [ Time Frame: 12 months after the intervention ]
    Useful Field of View computerized test of speed of processing and attention; lower score (in milliseconds) reflects better performance

  2. Resting high frequency heart rate variability (HF-HRV) at 12 months after the intervention [ Time Frame: 12 months after the intervention ]
    HF-HRV is derived by spectral analysis of the electrocardiograph (ECG) waveform and is a measure of parasympathetic control of the heart; Higher resting HF-HRV (in Hz) reflects greater parasympathetic regulation of the heart

  3. Emotion regulation at 12 months after the intervention [ Time Frame: 12 months after the intervention ]
    Measured as change in negative affect (from responses to the self-assessment manikin on a 9-point scale) from before to after a mental challenge; less increase in negative affect score suggests better emotion regulation

  4. Emotional well-being at 12 months after the intervention [ Time Frame: 12 months after the intervention ]
    The primary index of emotional well-being will be depressive symptoms (Center for Epidemiology Studies Depression scale); a lower score on this measure indicates less depressive symptoms

  5. Immune aging [ Time Frame: 12 months after the intervention ]
    Identified from blood samples; lower levels of inflammation (measured by enzyme-linked immunosorbent assay (ELISA) assay) and T-lymphocyte profiles that reflect larger ratios of naïve T-cells relative to mature T-cells (measured from flow cytometry) will index less aging of the immune system



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English-speaking (consent process and assessments will be conducted in English only)
  • Currently living with or in proximity to, and the primary caregiver for a loved one with dementia who lives in the community-for the purposes of this study, "loved one" refers to a family member such as a spouse, ex-spouse, significant other, sibling, in-law, parent, or other type of close established relationship (e.g., close friend) regarded as family; "primary caregivers" provide daily informal (non-paid) in-person care.
  • Currently experiencing moderate to high levels of perceived stress and caregiver burden. Caregivers will be screened for stress levels and caregiving burden using the 10-item Perceived Stress Scale (PSS 10) and the Modified Caregiver Strain Index (MCSI), respectively. Caregivers scoring above the population mean (approx.) on the PSS 10 (> 11), reporting at least moderate caregiver strain (score > 5) on the MCSI will be eligible for participation.

Exclusion Criteria:

  • cognitive impairment or dementia (identified by the Montreal Cognitive Assessment (MoCA)). Cutoff scores on the MoCA will be 23 or lower except for subjects who identify as black or African American, in which case cutoffs will be based on scores from the sample population reported in Rossetti et al (2017); subjects scoring greater than one standard deviation below the published score, by respective age and education, will be excluded.
  • current major depression (current Major Depression diagnosis and/or Geriatric Depression Scale (GDS 15) score > 10)
  • no recent (within 2 months) major surgery
  • History of events that cause neurological injury (e.g., stroke, transient ischemic attack, traumatic brain injury or head injury with loss of consciousness)
  • Serious psychiatric or alcohol/substance use disorders, including current alcohol dependence, current non-alcohol psychoactive substance use dependence, psychotic disorders or features (current and lifetime), bipolar disorder (determined from Mini International Neuropsychiatric Exam (MINI) modules)
  • Autoimmune disorder (e.g., Crohn's disease, lupus, rheumatoid arthritis)
  • Active neoplastic disease or receiving immunosuppressive therapy for cancer (or < 6 months post-chemo or radiation) or other diseases (< 3 months prior to enrollment)
  • No significant immunodeficiency disorder (e.g., alymphocytosis, hepatitis B or C, HIV)
  • Serious cardiovascular disease (e.g., congestive heart failure, pacemaker) or myocardial infarction within past 6 months
  • Physical condition precluding required activities as part of the computerized cognitive training (e.g., inability to use a computer mouse; inadequate visual acuity)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036423


Contacts
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Contact: Jeff Swan, MA 585-275-6835 mindbody@urmc.rochester.edu

Locations
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United States, New York
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Principal Investigator: Kathi L. Heffner, PhD         
Sub-Investigator: Jan A Moynihan, PhD         
Sub-Investigator: Silvia Sorensen, PhD         
Sub-Investigator: Carol Podgorski, PhD         
Sub-Investigator: Feng V Lin, PhD, RN         
Sub-Investigator: Mia Weber, PhD         
Sub-Investigator: Hugh Crean, PhD         
Sponsors and Collaborators
University of Rochester
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Kathi L Heffner, PhD University of Rochester
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Responsible Party: Kathi Heffner, Associate Professor of Nursing and Psychiatry, University of Rochester
ClinicalTrials.gov Identifier: NCT03036423    
Other Study ID Numbers: RSRB00058472
R01AG049764 ( U.S. NIH Grant/Contract )
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms