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Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers

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ClinicalTrials.gov Identifier: NCT03023332
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Jaclene A. Zauszniewski, Case Western Reserve University

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).

Condition or disease Intervention/treatment Phase
Distress Caregiver Behavioral: Resourcefulness Training Behavioral: Biofeedback training Behavioral: Bipolar Education Not Applicable

Detailed Description:

The study has two aims: The primary aim (A1) is to examine differences across the four groups (control, usual care, SM-need, and SM-preference) on caregiver health (health risks and mental and physical health) over time. We 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 usual care or control groups.

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: Self-management need
SM-need (i.e. need for bipolar education or resourcefulness training or HRV-focused biofeedback training or no need for any)
Behavioral: 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.

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 continue to influence behavior.

Behavioral: 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.

Experimental: Self-management preference
SM-preference (i.e. preference for bipolar education or resourcefulness training or HRV-focused biofeedback training or no intervention)
Behavioral: 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.

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 continue to influence behavior.

Behavioral: 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.

No Intervention: Control
No intervention or treatment
Active Comparator: Usual care
Bipolar education
Behavioral: 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.




Primary Outcome Measures :
  1. A1) Caregiver health [ Time Frame: 12 months ]
    Examine differences across the four groups (control, usual care, SM-need, SM-preference) on caregiver health (health risks and mental and physical health) over time.


Secondary Outcome Measures :
  1. A2) Caregiver baseline need / preference association [ Time Frame: 12 months ]
    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.

  2. A3) Build caregiver profiles [ Time Frame: 12 months ]
    Build caregiver profiles from demographic / contextual factors that are associated with their needs and preferences for the self-management interventions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

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): NCT03023332


Contacts
Contact: Jaclene Zauszniewski, PhD 216-368-3612 jaz@case.edu
Contact: Evelina DiFranco, MPH 216-368-8848 exd138@case.edu

Locations
United States, Ohio
CWRU School of Nursing Recruiting
Cleveland, Ohio, United States, 44106
Contact: Evelina DiFranco, MPH    216-368-8848    exd138@case.edu   
Sponsors and Collaborators
Case Western Reserve University

Responsible Party: Jaclene A. Zauszniewski, Principal Investigator, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT03023332     History of Changes
Other Study ID Numbers: 1R01NR016817-01 ( U.S. NIH Grant/Contract )
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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