Caregiver, Distress
Conditions
Keywords
Caregiver, Biofeedback, Resourcefulness, Self-Management
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.
Interventions
BEHAVIORALResourcefulness Training
A cognitive-behavioral intervention delivered through iPad technology that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
BEHAVIORALBiofeedback 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.
BEHAVIORALBipolar 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.
Sponsors
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
The only participants excluded from assignment signed a consent form but withdrew or did not respond to requests to complete T1. We do not report their subdivision into self-management interventions as, per our study Aims, we were not looking at the effects of the individual self-management interventions.
Participants by arm
| Arm | Count |
|---|---|
| Self-management Need SM-need (i.e. need for bipolar education or resourcefulness training or HRV-focused biofeedback training or no need for any)
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.
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.
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. | 86 |
| Self-management Preference SM-preference (i.e. preference for bipolar education or resourcefulness training or HRV-focused biofeedback training or no intervention)
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.
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.
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. | 86 |
| Control No intervention or treatment | 70 |
| Usual Care Bipolar education
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. | 68 |
| Total | 310 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 13 | 16 | 8 | 13 |
| Overall Study | Withdrawal by Subject | 10 | 5 | 4 | 7 |
Baseline characteristics
| Characteristic | Self-management Need | Self-management Preference | Control | Usual Care | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 13 Participants | 10 Participants | 9 Participants | 45 Participants |
| Age, Categorical Between 18 and 65 years | 73 Participants | 73 Participants | 60 Participants | 59 Participants | 265 Participants |
| Age, Continuous | 51.24 years STANDARD_DEVIATION 13.98 | 51.14 years STANDARD_DEVIATION 14.39 | 51.64 years STANDARD_DEVIATION 13.46 | 49.4 years STANDARD_DEVIATION 14.65 | 50.98 years STANDARD_DEVIATION 14.13 |
| Bipolar knowledge score | 21.94 units on a scale STANDARD_DEVIATION 3.36 | 22.08 units on a scale STANDARD_DEVIATION 3.55 | 22.16 units on a scale STANDARD_DEVIATION 3.55 | 21.59 units on a scale STANDARD_DEVIATION 3.39 | 22.05 units on a scale STANDARD_DEVIATION 3.49 |
| Global Health | 25.59 units on a scale STANDARD_DEVIATION 5.43 | 27.28 units on a scale STANDARD_DEVIATION 4.89 | 26.657 units on a scale STANDARD_DEVIATION 4.79 | 26.43 units on a scale STANDARD_DEVIATION 5.49 | 26.47 units on a scale STANDARD_DEVIATION 5.16 |
| Health Risks | 15.77 units on a scale STANDARD_DEVIATION 2.94 | 14.98 units on a scale STANDARD_DEVIATION 2.89 | 15.13 units on a scale STANDARD_DEVIATION 2.89 | 15.01 units on a scale STANDARD_DEVIATION 2.67 | 15.24 units on a scale STANDARD_DEVIATION 2.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants | 27 Participants | 24 Participants | 29 Participants | 117 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 7 Participants | 5 Participants | 1 Participants | 15 Participants |
| Race (NIH/OMB) White | 46 Participants | 49 Participants | 39 Participants | 38 Participants | 172 Participants |
| Region of Enrollment United States | 86 participants | 86 participants | 70 participants | 68 participants | 310 participants |
| Resourcefulness | 90.05 units on a scale STANDARD_DEVIATION 18.14 | 91.10 units on a scale STANDARD_DEVIATION 13.38 | 91.26 units on a scale STANDARD_DEVIATION 19.15 | 94.78 units on a scale STANDARD_DEVIATION 18.31 | 93.38 units on a scale STANDARD_DEVIATION 17.64 |
| Sex: Female, Male Female | 64 Participants | 66 Participants | 53 Participants | 52 Participants | 235 Participants |
| Sex: Female, Male Male | 22 Participants | 20 Participants | 17 Participants | 16 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 86 | 0 / 86 | 0 / 70 | 0 / 68 |
| other Total, other adverse events | 0 / 86 | 0 / 86 | 0 / 70 | 0 / 68 |
| serious Total, serious adverse events | 0 / 86 | 0 / 86 | 0 / 70 | 0 / 68 |
Outcome results
Primary
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
Time frame: 12 months
Population: All participants completing T1 and T3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Self-management Need | Change in Caregiver Health - Health Risks | T1: Baseline | 15.53 score on a scale | Standard Deviation 2.96 |
| Self-management Need | Change in Caregiver Health - Health Risks | T3: 12 month followup | 14.84 score on a scale | Standard Deviation 3.31 |
| Self-management Preference | Change in Caregiver Health - Health Risks | T3: 12 month followup | 15.00 score on a scale | Standard Deviation 3.12 |
| Self-management Preference | Change in Caregiver Health - Health Risks | T1: Baseline | 14.65 score on a scale | Standard Deviation 2.85 |
| Control | Change in Caregiver Health - Health Risks | T1: Baseline | 15.02 score on a scale | Standard Deviation 2.79 |
| Control | Change in Caregiver Health - Health Risks | T3: 12 month followup | 14.91 score on a scale | Standard Deviation 2.86 |
| Usual Care | Change in Caregiver Health - Health Risks | T1: Baseline | 14.80 score on a scale | Standard Deviation 2.91 |
| Usual Care | Change in Caregiver Health - Health Risks | T3: 12 month followup | 15.16 score on a scale | Standard Deviation 3.99 |
Primary
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.
Time frame: 12 months
Population: All participants completing T1 and T3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Self-management Need | Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System) | T1: Baseline | 25.95 score on a scale | Standard Deviation 5.27 |
| Self-management Need | Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System) | T3: 12 month followup | 27.45 score on a scale | Standard Deviation 4.97 |
| Self-management Preference | Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System) | T3: 12 month followup | 27.4 score on a scale | Standard Deviation 5.95 |
| Self-management Preference | Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System) | T1: Baseline | 27.77 score on a scale | Standard Deviation 4.99 |
| Control | Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System) | T1: Baseline | 26.66 score on a scale | Standard Deviation 4.61 |
| Control | Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System) | T3: 12 month followup | 26.62 score on a scale | Standard Deviation 5.46 |
| Usual Care | Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System) | T1: Baseline | 27.54 score on a scale | Standard Deviation 5.37 |
| Usual Care | Change in Global Health - PROMIS (Patient Reported Outcomes Measurement Information System) | T3: 12 month followup | 28.42 score on a scale | Standard Deviation 5.27 |
Secondary
Change in Bipolar Knowledge Assessment Scale
The scale measures caregiver knowledge of bipolar disorder using a 16 item scale. Scores range from 0-43, with higher scores indicating greater knowledge.
Time frame: 12 months
Population: All participants completing both T1 and T3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Self-management Need | Change in Bipolar Knowledge Assessment Scale | T3: 12 month followup | 22.29 score on a scale | Standard Deviation 3.55 |
| Self-management Need | Change in Bipolar Knowledge Assessment Scale | T1: Baseline | 21.90 score on a scale | Standard Deviation 3.62 |
| Self-management Preference | Change in Bipolar Knowledge Assessment Scale | T3: 12 month followup | 21.85 score on a scale | Standard Deviation 3.75 |
| Self-management Preference | Change in Bipolar Knowledge Assessment Scale | T1: Baseline | 22.58 score on a scale | Standard Deviation 3.31 |
| Control | Change in Bipolar Knowledge Assessment Scale | T1: Baseline | 22.11 score on a scale | Standard Deviation 3.64 |
| Control | Change in Bipolar Knowledge Assessment Scale | T3: 12 month followup | 22.47 score on a scale | Standard Deviation 3.69 |
| Usual Care | Change in Bipolar Knowledge Assessment Scale | T3: 12 month followup | 21.69 score on a scale | Standard Deviation 3.54 |
| Usual Care | Change in Bipolar Knowledge Assessment Scale | T1: Baseline | 21.48 score on a scale | Standard Deviation 3.37 |
Secondary
Change in Heart Rate Variability
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
Time frame: 12 months
Population: Participants completing both T1 and T3 questionnaires.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Self-management Need | Change in Heart Rate Variability | T1: Baseline | 56.64 milliseconds | Standard Deviation 57.82 |
| Self-management Need | Change in Heart Rate Variability | T3: 12 month followup | 63.34 milliseconds | Standard Deviation 50.67 |
| Self-management Preference | Change in Heart Rate Variability | T3: 12 month followup | 59.53 milliseconds | Standard Deviation 35.67 |
| Self-management Preference | Change in Heart Rate Variability | T1: Baseline | 50.41 milliseconds | Standard Deviation 30.57 |
| Control | Change in Heart Rate Variability | T1: Baseline | 67.94 milliseconds | Standard Deviation 147.48 |
| Control | Change in Heart Rate Variability | T3: 12 month followup | 69.58 milliseconds | Standard Deviation 76.63 |
| Usual Care | Change in Heart Rate Variability | T1: Baseline | 57.07 milliseconds | Standard Deviation 36.18 |
| Usual Care | Change in Heart Rate Variability | T3: 12 month followup | 44.14 milliseconds | Standard Deviation 28.85 |
Secondary
Change in Resourcefulness
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.
Time frame: 12 months
Population: All participants completing T1 and T3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Self-management Need | Change in Resourcefulness | T1: Baseline | 92.93 score on a scale | Standard Deviation 17.29 |
| Self-management Need | Change in Resourcefulness | T3: 12 month followup | 92.82 score on a scale | Standard Deviation 19.37 |
| Self-management Preference | Change in Resourcefulness | T3: 12 month followup | 93.81 score on a scale | Standard Deviation 15.87 |
| Self-management Preference | Change in Resourcefulness | T1: Baseline | 92.78 score on a scale | Standard Deviation 13.79 |
| Control | Change in Resourcefulness | T1: Baseline | 93.15 score on a scale | Standard Deviation 20.1 |
| Control | Change in Resourcefulness | T3: 12 month followup | 94.29 score on a scale | Standard Deviation 19.24 |
| Usual Care | Change in Resourcefulness | T1: Baseline | 94.83 score on a scale | Standard Deviation 19.72 |
| Usual Care | Change in Resourcefulness | T3: 12 month followup | 96.49 score on a scale | Standard Deviation 17.88 |