Clinical trial NCT03023332: Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers
Official title: Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distress
Caregiver
Keywords: Caregiver
Biofeedback
Resourcefulness
Self-Management
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
First posted: 2017-01-18
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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)

Primary outcomes:
measure: Change in Caregiver Health - Health Risks
timeFrame: 12 months
measure: Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)
timeFrame: 12 months
Secondary outcomes:
measure: Change in Bipolar Knowledge Assessment Scale
timeFrame: 12 months
measure: Change in Heart Rate Variability
timeFrame: 12 months
measure: Change in Resourcefulness
timeFrame: 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: CWRU School of Nursing
state: Ohio
Study officials:
affiliation: Case Western Reserve University - Frances Payne Bolton School of Nursing
name: Jaclene Zauszniewski, PhD
role: PRINCIPAL_INVESTIGATOR
References: