Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers



Status:Recruiting
Healthy:No
Age Range:18 - 120
Updated:2/7/2019
Start Date:June 12, 2017
End Date:October 2020
Contact:Jaclene Zauszniewski, PhD
Email:jaz@case.edu
Phone:216-368-3612

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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).

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.

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)
We found this trial at
1
site
10900 Euclid Avenue
Cleveland, Ohio 44106
Phone: 216-368-8848
?
mi
from
Cleveland, OH
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