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Trial record 1 of 1 for:    NCT03036423
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Cognitive Training for Older Caregivers (CTC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03036423
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : November 4, 2020
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Kathi Heffner, University of Rochester

Tracking Information
First Submitted Date  ICMJE November 10, 2016
First Posted Date  ICMJE January 30, 2017
Last Update Posted Date November 4, 2020
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2017)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Cognitive Training for Older Caregivers
Official Title  ICMJE Cognitive Training to Protect Immune Systems of Older Caregivers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Life Stress
Intervention  ICMJE
  • Behavioral: Online video education
  • Behavioral: Computerized mental exercises
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Behavioral: Computerized mental exercises
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2017)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jeff Swan, MA 585-275-6835
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03036423
Other Study ID Numbers  ICMJE RSRB00058472
R01AG049764 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kathi Heffner, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Kathi L Heffner, PhD University of Rochester
PRS Account University of Rochester
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP