Dementia Caregiver Career Study

Study Overview
=================
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 Alzheimer's and other dementia disorders? Caregivers will be randomized to 1) information on diversional activities (attention control); 2) self-management intervention based on need (SM-need); or 3) 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 three groups (attention control, SM-need, and SM-preference) on caregiver health (health risks and mental and physical health) over time. The investigators 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 attention control. 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), about 6 months (T2), and about 12 months (T3). Caregivers will be randomly assigned to one of three groups. The attention control group will receive information on diversional activities. The SM-need group will receive a self-management intervention for biofeedback training or resourcefulness training, as determined by baseline cut scores. Caregivers in the SM-preference group will choose one of the two self-management interventions according to their personal preference. Both self-management interventions (biofeedback training, resourcefulness training) and the diversional activities, are delivered over four weeks (between T1 and T2). Caregivers may use the intervention whenever and as often as they wish (i.e. self-tailoring) for the remainder of the study period. These resourcefulness training includes teaching self-help (stress-management, problem-solving) and help-seeking skills, respectively. Biofeedback training consists of the 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.

Official Title
-----------------
Self-Management Interventions: Considering Needs & Preferences of Dementia Caregivers

Conditions
-----------------
Bereavement, Stress, Carer Stress Syndrome, Dementia, Alzheimer's Disease

Intervention / Treatment
-----------------
* Behavioral: Resourcefulness Training
* Behavioral: Biofeedback Training
* Behavioral: Diversional Activites


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old Have a living family member or a recently deceased family member diagnosed with Alzheimer's disease or another dementia Identify self as a primary caregiver In-home Caregivers: must be currently providing a minimum of 4 hours per day of supervision/direct care, and have entered that role within the past twelve months; Care Partners whose family member moved into a nursing or assisted living facility within the past twelve months, and must report visiting their care recipient at least once per week; Caretakers (i.e. bereaved) whose family member is deceased within the past twelve months, and are persons with direct oversight of the deceased person's belongings, estate, finances, etc. Be capable of performing informed consent and participating in study procedures Exclusion Criteria: Does not have a family member with Alzheimer's disease or another dementia Has not cared for a living family member with dementia within the last 12 months, or the family member has been deceased for more than 12 months Has knowledge of another family member in the same household enrolled in the study Currently pregnant Has a pacemaker Lives outside of the study area

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Management<br> | Behavioral: Resourcefulness Training<br>* A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.<br>Behavioral: Biofeedback Training<br>* 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 to continue to influence behavior.<br>|
| Active Comparator: Attention Control Condition<br> | Behavioral: Diversional Activites<br>* An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Caregiver's Global Health | Change in self-assessment of general physical and mental health, as measured by the Patient-Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10 Global Health). Ten items are rated on a five-point scale, scores range from 10-50, and a higher score indicates better health and health-related quality of life. | From T1 (baseline) to T2 (6 months) through T3 (one year) | 
| Change in Caregiver's Health Risk Behavior Scale | 9 items; 3-point scale, Scores range 9-27; higher score indicates greater risk | From T1 (baseline) to T2 (6 months) through T3 (one year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Caregiver's Heart Rate Variability | Changes in the heart rate variability (HRV), as measured through non-invasive heart rate monitoring and scored in standard deviations of milliseconds of fluctuation from average heart rate. While range norms are specific to age and cardiovascular function, higher scores indicate lower levels of stress, and greater adaptability and resilience of the autonomic nervous system in response to stress. | From T1 (baseline) to T2 (6 months) through T3 (one year) | 
| Change in Caregiver's Resourcefulness Scale | 28 items; 6-point scale; Scores range 0-140; higher score indicates more resourcefulness | From T1 (baseline) to T2 (6 months) through T3 (one year) | 
| Change in Caregiver's Perceived Stress Scale | 14 items; 3-point scale; Scores range 9-27; higher score indicates greater perceived stress | From T1 (baseline) to T2 (6 months) through T3 (one year) | 
| Change in Caregiver's Depressive Cognitions Scales | 8 items; 6-point scale; Scores range 0-40; higher score indicates higher depressive cognition | From T1 (baseline) to T2 (6 months) through T3 (one year) | 
| Change in Caregiver's Negative Emotions Checklist | 10 items; dichotomous list; Scores range 0-10; higher score indicates more negative emotions. | From T1 (baseline) to T2 (6 months) through T3 (one year) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caregiver, Biofeedback, Resourcefulness, Self-Management