Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers
1 other identifier
interventional
310
1 country
1
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 bipolar disorder? Caregivers will be randomized to: 1) a control group (no intervention); 2) education (usual care); 3) self-management intervention based on need (SM-need); or 4) self-management intervention of their preference (SM-preference).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2017
CompletedFirst Posted
Study publicly available on registry
January 18, 2017
CompletedStudy Start
First participant enrolled
June 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedResults Posted
Study results publicly available
November 15, 2023
CompletedNovember 15, 2023
November 1, 2023
4.1 years
January 13, 2017
August 25, 2023
November 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Caregiver Health - Health Risks
Health risks were measured using the Change in Health Risk Behavior Scale. The scale consists of 9 items measured on a 3-point scale, Scores range 9-27; higher score indicates greater risk
12 months
Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)
Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System) scale. 5 items - physical health; 5 items - mental health; 5-point scale; Scores range 0-40; higher scores indicate better health.
12 months
Secondary Outcomes (3)
Change in Bipolar Knowledge Assessment Scale
12 months
Change in Heart Rate Variability
12 months
Change in Resourcefulness
12 months
Study Arms (4)
Self-management need
EXPERIMENTALSM-need (i.e. need for bipolar education or resourcefulness training or HRV-focused biofeedback training or no need for any)
Self-management preference
EXPERIMENTALSM-preference (i.e. preference for bipolar education or resourcefulness training or HRV-focused biofeedback training or no intervention)
Control
NO INTERVENTIONNo intervention or treatment
Usual care
ACTIVE COMPARATORBipolar education
Interventions
A cognitive-behavioral intervention delivered through iPad technology 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 continue to influence behavior.
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
You may qualify if:
- English-speaking
- 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
You may not qualify if:
- Does not have family member with bipolar disorder
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CWRU School of Nursing
Cleveland, Ohio, 44106, United States
Related Publications (1)
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.
PMID: 39535112DERIVED
Results Point of Contact
- Title
- Jaclene Zauszniewski, PhD
- Organization
- Case Western Reserve University
Study Officials
- PRINCIPAL INVESTIGATOR
Jaclene Zauszniewski, PhD
Case Western Reserve University - Frances Payne Bolton School of Nursing
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 13, 2017
First Posted
January 18, 2017
Study Start
June 12, 2017
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
November 15, 2023
Results First Posted
November 15, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share