- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04603482
Dementia Caregiver Career Study
Self-Management Interventions: Considering Needs & Preferences of Dementia Caregivers
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jaclene A Zauszniewski, PhD
- Phone Number: 216-368-3612
- Email: jaz@case.edu
Study Contact Backup
- Name: Evelina DiFranco, MPH
- Email: exd138@case.edu
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- CWRU School of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Self-Management
|
A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From T1 (baseline) to T2 (6 months) through T3 (one year)
|
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
|
From T1 (baseline) to T2 (6 months) through T3 (one year)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From T1 (baseline) to T2 (6 months) through T3 (one year)
|
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
|
From T1 (baseline) to T2 (6 months) through T3 (one year)
|
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
|
From T1 (baseline) to T2 (6 months) through T3 (one year)
|
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
|
From T1 (baseline) to T2 (6 months) through T3 (one year)
|
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.
|
From T1 (baseline) to T2 (6 months) through T3 (one year)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01NR018476 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carer Stress Syndrome
-
The Hong Kong Polytechnic UniversityCompletedCarer Stress Syndrome | DementiaHong Kong
-
The Hong Kong Polytechnic UniversityHong Kong Young Women's Christian AssociationCompletedCarer Stress Syndrome | DementiaHong Kong
-
Mount Sinai Hospital, CanadaCompletedCarer Stress SyndromeCanada
-
Case Western Reserve UniversityCompletedCarer Stress Syndrome | Stress | Dementia | Alzheimer DiseaseUnited States
-
German Center for Neurodegenerative Diseases (DZNE)University Medicine Greifswald; Gemeinsamer Bundesausschuss (GBA)CompletedCarer Stress Syndrome | Dementia | Relatives | Caregiver Burnout | Partner, DomesticGermany
-
University of NottinghamUnknownCarer Stress SyndromeUnited Kingdom
-
University of Colorado, DenverCompletedBurn-Out Syndrome | Work-Related Stress DisorderUnited States
-
US Department of Veterans AffairsCompletedGulf War Syndrome | Chronic Fatigue Syndrome | Post-Traumatic Stress DisorderUnited States
-
University of Colorado, DenverNational Endowment for the Arts, United StatesRecruitingDepression, Anxiety | Post-Traumatic Stress Disorder | Burn-Out SyndromeUnited States
-
Brooke Army Medical CenterUnknown
Clinical Trials on Resourcefulness Training
-
University Hospitals Cleveland Medical CenterThe Cleveland Clinic; Case Western Reserve UniversityCompletedGastrostomy | Chronic Illness | Caregiver | Mindfulness | Mechanical Ventilation Pressure HighUnited States
-
University Hospitals Cleveland Medical CenterNational Institute of Nursing Research (NINR)CompletedDepressive Symptoms | Multiple Chronic Conditions | Family CaregiversUnited States
-
University Hospitals Cleveland Medical CenterCompletedParents | Caregivers | Self-Management | Chronic Illnesses, MultipleUnited States
-
Case Western Reserve UniversityCompletedDistress | CaregiverUnited States
-
Case Western Reserve UniversityCompletedCarer Stress Syndrome | Stress | Dementia | Alzheimer DiseaseUnited States
-
National Taipei University of Nursing and Health...National Science and Technology CouncilRecruiting
-
National Taipei University of Nursing and Health...CompletedQuality of Life | Recovery | Chronic SchizophreniaTaiwan
-
Chang Gung Memorial HospitalCompleted
-
University of Trás-os-Montes and Alto DouroCompletedLipid Metabolism Disorders | Sarcopenia | Osteoporosis | Overweight and Obesity | Personal Satisfaction | Hypertension With Complications and Secondary HypertensionPortugal