Tailored Health Self-Management Interventions for Highly Distressed Family Caregivers

Not Applicable

Completed

Conditions: Caregiver
Distress

Interventions: Behavioral: Resourcefulness Training
Behavioral: Biofeedback training
Behavioral: Bipolar Education

Registration Number: NCT03023332

Lead Sponsor: 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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 310

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-management need	Resourcefulness Training	SM-need (i.e. need for bipolar education or resourcefulness training or HRV-focused biofeedback training or no need for any)
Self-management need	Biofeedback training	SM-need (i.e. need for bipolar education or resourcefulness training or HRV-focused biofeedback training or no need for any)
Self-management need	Bipolar Education	SM-need (i.e. need for bipolar education or resourcefulness training or HRV-focused biofeedback training or no need for any)
Self-management preference	Resourcefulness Training	SM-preference (i.e. preference for bipolar education or resourcefulness training or HRV-focused biofeedback training or no intervention)
Self-management preference	Biofeedback training	SM-preference (i.e. preference for bipolar education or resourcefulness training or HRV-focused biofeedback training or no intervention)
Usual care	Bipolar Education	Bipolar education
Self-management preference	Bipolar Education	SM-preference (i.e. preference for bipolar education or resourcefulness training or HRV-focused biofeedback training or no intervention)

Primary Outcome Measures

Name	Time	Method
Change in Caregiver Health - Health Risks	12 months	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
Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Resourcefulness	12 months	Participant Resourcefulness scale score. Composite item comprising of responses to 28 items scored on a 6 point likert scale. Scores range from 0-140, with higher scores indicating greater resourcefulness.
Change in Bipolar Knowledge Assessment Scale	12 months	The scale measures caregiver knowledge of bipolar disorder using a 16 item scale. Scores range from 0-43, with higher scores indicating greater knowledge.
Change in Heart Rate Variability	12 months	HRV is a physiological measure of the healthy functioning of the heart. It is a well-established biomarker for detecting stress. HRV was measured using the BioRadio portable limb-lead electrocardiogram recorder. A sensor was placed on the radial area of the caregiver's forearm for 5 minutes; they were asked to remain still as possible to prevent artifacts in the readings. The data obtained via this device was analyzed with compatible VivoSense software, which automatically computed 8 HRV parameters. One of these was the SDNN score, which is the recognized and most commonly used gold standard biomarker indicative of stress. The SDNN score is the standard deviation of all normal to normal R-R intervals between heartbeats and reported in milliseconds. The SDNN was the outcome of interest for our study as a physiological indicator of stress. For each caregiver, the software produced an average score for the 5-minute measurement