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Dementia Caregiver Career Study

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ClinicalTrials.gov Identifier: NCT04603482
Recruitment Status : Recruiting
First Posted : October 26, 2020
Last Update Posted : December 14, 2022
Sponsor:
Information provided by (Responsible Party):
Jaclene A. Zauszniewski, Case Western Reserve University

Study Description
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Brief Summary:
How do varying levels of participation in selecting self-management interventions (ranging from no input into the selection to selection based on need or preference) affect health risks and physical and mental health over time in family caregivers of persons with Alzheimer's and other dementia disorders? Caregivers will be randomized to 1) information on diversional activities (attention control); 2) self-management intervention based on need (SM-need); or 3) self-management intervention of their preference (SM-preference).

Condition or disease Intervention/treatment Phase
Stress Carer Stress Syndrome Dementia Alzheimer's Disease Bereavement Behavioral: Resourcefulness Training Behavioral: Biofeedback Training Behavioral: Diversional Activites Not Applicable

Detailed Description:

The study has two aims: The primary aim (A1) is to examine differences across the three groups (attention control, SM-need, and SM-preference) on caregiver health (health risks and mental and physical health) over time. The investigators hypothesize that the caregivers who receive a self-management intervention based on need (SM-need) or preference (SM-preference) will have better health outcomes than those in the attention control.

Secondary aims are to: A2) explore whether caregiver baseline need or preference for intervention (i.e. choice) is associated with: a) care recipient's symptoms; b) caregiver reactions; and c) caregiving involvement, and A3) build caregiver profiles from demographic/ contextual factors that are associated with their needs and preferences for the self-management interventions.

All caregivers will complete assessment measures and measures of health risks, and physical and mental health at baseline (T1), about 6 months (T2), and about 12 months (T3). Caregivers will be randomly assigned to one of three groups. The attention control group will receive information on diversional activities. The SM-need group will receive a self-management intervention for biofeedback training or resourcefulness training, as determined by baseline cut scores. Caregivers in the SM-preference group will choose one of the two self-management interventions according to their personal preference.

Both self-management interventions (biofeedback training, resourcefulness training) and the diversional activities, are delivered over four weeks (between T1 and T2). Caregivers may use the intervention whenever and as often as they wish (i.e. self-tailoring) for the remainder of the study period. These resourcefulness training includes teaching self-help (stress-management, problem-solving) and help-seeking skills, respectively. Biofeedback training consists of the use of a hand-held device that shows the participant their changes in heart rate based on changes in their breathing pattern (as they relax); caregivers who need or prefer the biofeedback will be given a device to use for 28 days. All study participants receiving the intervention will also be asked to keep a journal to record their experience with the intervention.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Self-Management Interventions: Considering Needs & Preferences of Dementia Caregivers
Actual Study Start Date : January 8, 2021
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Self-Management Behavioral: Resourcefulness Training
A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.

Behavioral: Biofeedback Training
Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate "feedback" to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior.
Active Comparator: Attention Control Condition Behavioral: Diversional Activites
An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Caregiver's Global Health [ Time Frame: From T1 (baseline) to T2 (6 months) through T3 (one year) ]
    Change in self-assessment of general physical and mental health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 10-50, and a higher score indicates better health and health-related quality of life.

  2. Change in Caregiver's Health Risk Behavior Scale [ Time Frame: From T1 (baseline) to T2 (6 months) through T3 (one year) ]
    9 items; 3-point scale, Scores range 9-27; higher score indicates greater risk


Secondary Outcome Measures :
  1. Change in Caregiver's Heart Rate Variability [ Time Frame: From T1 (baseline) to T2 (6 months) through T3 (one year) ]
    Changes in the heart rate variability (HRV), as measured through non-invasive heart rate monitoring and scored in standard deviations of milliseconds of fluctuation from average heart rate. While range norms are specific to age and cardiovascular function, higher scores indicate lower levels of stress, and greater adaptability and resilience of the autonomic nervous system in response to stress.

  2. Change in Caregiver's Resourcefulness Scale [ Time Frame: From T1 (baseline) to T2 (6 months) through T3 (one year) ]
    28 items; 6-point scale; Scores range 0-140; higher score indicates more resourcefulness

  3. Change in Caregiver's Perceived Stress Scale [ Time Frame: From T1 (baseline) to T2 (6 months) through T3 (one year) ]
    14 items; 3-point scale; Scores range 9-27; higher score indicates greater perceived stress

  4. Change in Caregiver's Depressive Cognitions Scales [ Time Frame: From T1 (baseline) to T2 (6 months) through T3 (one year) ]
    8 items; 6-point scale; Scores range 0-40; higher score indicates higher depressive cognition

  5. Change in Caregiver's Negative Emotions Checklist [ Time Frame: From T1 (baseline) to T2 (6 months) through T3 (one year) ]
    10 items; dichotomous list; Scores range 0-10; higher score indicates more negative emotions.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years old
  • Have a living family member or a recently deceased family member diagnosed with Alzheimer's disease or another dementia
  • Identify self as a primary caregiver
  • In-home Caregivers: must be currently providing a minimum of 4 hours per day of supervision/direct care, and have entered that role within the past twelve months; Care Partners whose family member moved into a nursing or assisted living facility within the past twelve months, and must report visiting their care recipient at least once per week; Caretakers (i.e. bereaved) whose family member is deceased within the past twelve months, and are persons with direct oversight of the deceased person's belongings, estate, finances, etc.
  • Be capable of performing informed consent and participating in study procedures

Exclusion Criteria:

  • Does not have a family member with Alzheimer's disease or another dementia
  • Has not cared for a living family member with dementia within the last 12 months, or the family member has been deceased for more than 12 months
  • Has knowledge of another family member in the same household enrolled in the study
  • Currently pregnant
  • Has a pacemaker
  • Lives outside of the study area
Contacts and Locations
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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): NCT04603482


Contacts
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Contact: Jaclene A Zauszniewski, PhD 216-368-3612 jaz@case.edu
Contact: Evelina DiFranco, MPH exd138@case.edu

Locations
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United States, Ohio
CWRU School of Nursing Recruiting
Cleveland, Ohio, United States, 44106
Contact: Evelina DiFranco, MPH         
Sponsors and Collaborators
Case Western Reserve University
More Information
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Responsible Party: Jaclene A. Zauszniewski, Principal Investigator, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT04603482    
Other Study ID Numbers: R01NR018476 ( U.S. NIH Grant/Contract )
First Posted: October 26, 2020    Key Record Dates
Last Update Posted: December 14, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaclene A. Zauszniewski, Case Western Reserve University:
Caregiver
Biofeedback
Resourcefulness
Self-Management
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders