Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers
NCT ID: NCT03023332
Last Updated: 2023-11-15
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
310 participants
INTERVENTIONAL
2017-06-12
2021-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tailored Health Self-Management Interventions for Highly Distressed Caregivers: Family Members of Persons With Dementia
NCT04247347
Improving Outcomes for Care Partners of Persons With Traumatic Brain Injury
NCT04570930
Optimizing Behavioral Health Homes for Adults With Serious Mental Illness
NCT02318797
Problem Solving for Caregivers of Persons With Brain Injury
NCT00164645
Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI
NCT02057081
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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), 6 months (T2) and 12 months (T3). Caregivers will randomly assigned to one of four groups. The control group will receive no intervention. The usual care group will receive bipolar education. The SM-need group will receive a self-management intervention tailored to meet their need for bipolar education, biofeedback training, or resourcefulness training, as determined by baseline cut scores. Caregivers in the SM-preference group will choose one of the three self-management intervention according to their personal preference.
All three self-management interventions (bipolar education, biofeedback training, resourcefulness training) are delivered over four weeks (between T1 and T2). Caregivers may use the one SM intervention whenever and as often as they wish (i.e. self-tailoring) for the remainder of the study period. The bipolar education and resourcefulness training interventions will be delivered initially using an iPad. These interventions involve providing educational information about bipolar disorder or teaching self-help (stress-management, problem-solving) and help-seeking skills, respectively. Biofeedback training consists of 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Self-management need
SM-need (i.e. need for bipolar education or resourcefulness training or HRV-focused biofeedback training or no need for any)
Resourcefulness Training
A cognitive-behavioral intervention delivered through iPad technology that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
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 continue to influence behavior.
Bipolar Education
An educational program designed to teach family caregivers of about the types, causes, symptoms, episodes, warning signs, and treatments for individuals with bipolar disorder, as well as available resources for assisting a family member with bipolar disorder. The content to be presented within an audiovisual format using iPad technology follows the recommendations and guidelines developed through research and by the Depression and Bipolar Support Alliance and the National Institute of Mental Health.
Self-management preference
SM-preference (i.e. preference for bipolar education or resourcefulness training or HRV-focused biofeedback training or no intervention)
Resourcefulness Training
A cognitive-behavioral intervention delivered through iPad technology that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
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 continue to influence behavior.
Bipolar Education
An educational program designed to teach family caregivers of about the types, causes, symptoms, episodes, warning signs, and treatments for individuals with bipolar disorder, as well as available resources for assisting a family member with bipolar disorder. The content to be presented within an audiovisual format using iPad technology follows the recommendations and guidelines developed through research and by the Depression and Bipolar Support Alliance and the National Institute of Mental Health.
Control
No intervention or treatment
No interventions assigned to this group
Usual care
Bipolar education
Bipolar Education
An educational program designed to teach family caregivers of about the types, causes, symptoms, episodes, warning signs, and treatments for individuals with bipolar disorder, as well as available resources for assisting a family member with bipolar disorder. The content to be presented within an audiovisual format using iPad technology follows the recommendations and guidelines developed through research and by the Depression and Bipolar Support Alliance and the National Institute of Mental Health.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Resourcefulness Training
A cognitive-behavioral intervention delivered through iPad technology that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
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 continue to influence behavior.
Bipolar Education
An educational program designed to teach family caregivers of about the types, causes, symptoms, episodes, warning signs, and treatments for individuals with bipolar disorder, as well as available resources for assisting a family member with bipolar disorder. The content to be presented within an audiovisual format using iPad technology follows the recommendations and guidelines developed through research and by the Depression and Bipolar Support Alliance and the National Institute of Mental Health.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least 18 years old
* Have a family member with bipolar disorder
* Have cared/supported them for at least the last 6 months in the last year
* Be capable of performing the informed consent and participate in interventions
Exclusion Criteria
* Has not cared for family member for at least 6 months in the last year
* Knowledge of another family member in the same household enrolled in the study
* Is pregnant
* Has a pacemaker
* Lives outside of the study area (Cuyahoga, Lake, Geauga, Portage, Summit, Medina, and Lorain counties)
18 Years
120 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Case Western Reserve University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jaclene A. Zauszniewski
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jaclene Zauszniewski, PhD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University - Frances Payne Bolton School of Nursing
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CWRU School of Nursing
Cleveland, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Zauszniewski JA, Burant CJ, Juratovac E, Jeanblanc A, Sweetko JS, Larsen C, Almutairi R, She HY, DiFranco E, Colon-Zimmerman K, Sajatovic M. Acquiring Resourcefulness Skills: Formal Versus Informal Training. West J Nurs Res. 2025 Jan;47(1):5-14. doi: 10.1177/01939459241296613. Epub 2024 Nov 13.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.