Behavioral Variant of Frontotemporal Dementia, Caregiver Stress Syndrome
Conditions
Brief summary
The research study is being conducted to evaluate the efficacy of a virtual support intervention to reduce stress and poor self-care for caregivers of persons with behavioral variant Frontotemporal Degeneration (bvFTD) compared to receiving health information alone.
Detailed description
Informal caregivers of persons with Frontotemporal degeneration (FTD) are an understudied population with unique needs. FTD is a common cause of young-onset dementia with no known cure. Behavioral variant FTD (bvFTD) is the most common of the FTD syndromes and involves a progressive disorder of emotional regulation and personality, and significant impairment in executive function. bvFTD caregivers face unique challenges which are particularly stressful, including young age at which the disorder appears, behavioral symptoms like apathy and disinhibition that are severe and appear early in bvFTD, and the lack of appropriate supportive services. Indeed, numerous studies have demonstrated that stress, depression and burden are higher in FTD caregivers than in any of the other ADRDs, yet caregiver interventions tested in specifically in the FTD population have been limited to a few small studies that focus on education around patient behavior management, not caregiver self-care. The research study is being conducted to evaluate the efficacy of a virtual support intervention to reduce stress and poor self-care for caregivers of persons with behavioral variant Frontotemporal Degeneration (bvFTD) compared to receiving health information alone. 30 caregivers will be randomized 1:1 to a health information: health information + health coaching group. Catered information will be delivered via tablets over 6 months with testing dispersed at baseline, 1 month, 3 months, and 6 months.
Interventions
BEHAVIORALHealth Information + Health Coaching
Virtual Health Coaching for You: The focus of these sessions is helping caregivers take care of themselves. These are virtual health coaching sessions by trained Health Coaches over 6 months with content based on the theoretical framework from our prior research
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Investigators and all staff involved in collecting assessment data will be blinded to group assignment until after the data are locked. The Health Coaches providing the intervention and the caregiver participants will not be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informal caregiver providing care at least 8 hours/week * Reporting poor self-care on screening (Health Self-Care Neglect Scale, score ≥ 2) * Able to complete the protocol, e.g., adequate vision and hearing, English speaking * Caregiver of a patient diagnosed bvFTD
Exclusion criteria
* Participation in another support randomized, controlled trial * Untreated major psychiatric illness (Use of anti-anxiety/anti-depressant medicines is acceptable and will be adjusted in analysis if group imbalance is identified.) * Caregiver with Cognitive Impairment based on Telephone Interview for Cognitive Status (TICS) score \<25
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Self-Care Inventory (SCI) | 6 months | 30 items scored 0-100. A higher score indicates better self-care. This theoretically-derived instrument has construct validity. The self-care confidence scale is embedded within this instrument. |
| Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | 6 months | The FTDRS includes 30 questions covering 7 categories: behavior, outing and shopping, household chores and telephone, finances, medications, meal preparation and eating, and self care and mobility. Each question is scored on a likert scale of never (0) to all the time (2). Higher scores represents more frequent symptoms. The reported scores are the mean/standard deviation for the first 7 questions (Category: Behavior). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ways of Coping Questionnaire, Short Form | 6 months | This 42-item questionnaire measures the use of five different coping styles: avoidance, problem-focused, seeking social support, self-blame, and wishful thinking. The original scale has been used widely since developed by Lazarus in 1985. The short version (30 items) uses a 4-point Likert-scale response format (0 = not used to 3 = used a great deal). Scores range from 0-90 with higher scores indicating greater coping. It is reliable (alpha 0.95) and has construct validity. This instrument has been used numerous times in studies with older adult caregivers. |
| Change From Baseline in Perceived Stress Scale | 6 months | The Perceived Stress Scale is a 14-item instrument that provides a global rating of an individual's belief in the severity and frequency of stressful experiences during the last month. The Perceived Stress Scale includes 14 items designed to assess symptoms of stress and global measures of the degree of stress experienced in the past month. Each item is scored from 0 (never) to 4 (very often), with total sum scores ranging from 0 to 56; higher scores indicate higher perceived stress. |
| Change From Baseline in Neuropsychiatric Inventory | 6 months | Commonly used scale to evaluate 12 common behaviors in dementia including Delusions, Hallucinations, Agitation/Aggression, Depression, Anxiety, Elation/Euphoria, Apathy/Indifference, Disinhibition, Irritability, Aberrant motor behavior, Sleep and Nighttime Behavior Disorders, Appetite and Eating Disorders. Ratings include the frequency of the occurrence of behaviors (1 = occasionally, 2 = often, 3 = frequently, 4 = very frequently), and the level of severity of behaviors (1 = mild, 2 = moderate, 3 = severe). The behavioral domain total score is the product of the frequency score multiplied by the severity score for that behavior. The NPI total score is the sum of all the individual behavioral domains. Scores range from 0-144. Higher scores demonstrate greater symptoms frequency and severity. |
| Change From Baseline in Zarit Burden Interview (ZBI) | 6 months | The ZBI has been used in numerous informal dementia caregiver studies to capture burden associated with providing care to a loved one. Total scores are summed and a range is provided for little to no burden (0-21) to severe burden (61-88). |
| Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) | 6 months | CES-D is a valid and reliable scale for detecting caregiver depression in dementia. The scoring is on a likert scale 0: Rarely or none of the time (less than 1 day), 1: Some or a little of the time (1-2 days), 2: Occasionally or a moderate amount of time (3-4 days), and 3: Most or all of the time (5-7 days). Higher scores represent greater depressive symptoms. Total scores can range 0 to 60. A score equal or above a 16 means a person is at risk for clinical depression. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited by clinician referral from the University of Pennsylvania Frontotemporal Degeneration Center between December 2020 to April 2021. The first participant was enrolled in December 2020 and the final was enrolled in April 2021. Data collection began in December 2020 and finished in November 2021.
Pre-assignment details
Of 43 people contacted for recruitment, 8 declined to participate and 4 were ineligible. 31 were randomized to the protocol.
Participants by arm
| Arm | Count |
|---|---|
| ViCCY: Health Information + Health Coaching This group will receive 10 front-loaded sessions of virtual health coaching by trained Health Coaches over 6 months with content based on the theoretical framework our prior research. Sessions are provided using tablets. Initially, sessions are weekly to build the relationship, but the frequency of sessions decreases over time
Health Information + Health Coaching: Virtual Health Coaching for You: The focus of these sessions is helping caregivers take care of themselves. These are virtual health coaching sessions by trained Health Coaches over 6 months with content based on the theoretical framework from our prior research | 15 |
| Health Information Caregivers in the Health Information group are asked to spend at least 30 minutes weekly using the computer tablet provided to you by the study team to access recommended websites | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Health Information | ViCCY: Health Information + Health Coaching | Total |
|---|---|---|---|
| Age, Continuous | 65.07 years STANDARD_DEVIATION 9.95 | 62.80 years STANDARD_DEVIATION 11.3 | 63.93 years STANDARD_DEVIATION 10.52 |
| Clinical Dementia Rating Scale-Frontotemporal Lobar Degeneration (global score) | 1.70 units on a scale STANDARD_DEVIATION 0.75 | 1.82 units on a scale STANDARD_DEVIATION 0.96 | 1.77 units on a scale STANDARD_DEVIATION 0.85 |
| Education of Caregiver (years) Bachelor's Degree | 3 Participants | 4 Participants | 7 Participants |
| Education of Caregiver (years) Doctoral or Professional Degree | 8 Participants | 8 Participants | 16 Participants |
| Education of Caregiver (years) Grade School | 1 Participants | 0 Participants | 1 Participants |
| Education of Caregiver (years) High School graduate or GED | 1 Participants | 2 Participants | 3 Participants |
| Education of Caregiver (years) Trade School or some college | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race of Caregiver Asian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race of Caregiver Black or AA | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race of Caregiver Multi-Racial | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race of Caregiver Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race of Caregiver White or Caucasian | 13 Participants | 13 Participants | 26 Participants |
| Relationship to Patient Daughter | 0 Participants | 1 Participants | 1 Participants |
| Relationship to Patient Mother | 1 Participants | 0 Participants | 1 Participants |
| Relationship to Patient Other Relative | 1 Participants | 0 Participants | 1 Participants |
| Relationship to Patient Spouse | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Female | 10 Participants | 12 Participants | 22 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
| Time as Caregiver (years) | 4.99 years STANDARD_DEVIATION 3.26 | 4.97 years STANDARD_DEVIATION 2.26 | 4.98 years STANDARD_DEVIATION 2.75 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS)
The FTDRS includes 30 questions covering 7 categories: behavior, outing and shopping, household chores and telephone, finances, medications, meal preparation and eating, and self care and mobility. Each question is scored on a likert scale of never (0) to all the time (2). Higher scores represents more frequent symptoms. The reported scores are the mean/standard deviation for the first 7 questions (Category: Behavior).
Time frame: 6 months
Population: skipped question by participant
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ViCCY: Health Information + Health Coaching | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q2- Month 6 | 1.53 score on a scale | Standard Deviation 0.64 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q3- Baseline | 2.14 score on a scale | Standard Deviation 0.77 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q3- Month 6 | 2.13 score on a scale | Standard Deviation 0.64 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q4- Baseline | 1.73 score on a scale | Standard Deviation 0.7 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q4- Month 6 | 1.93 score on a scale | Standard Deviation 0.46 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q5- Baseline | 2.00 score on a scale | Standard Deviation 0.53 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q5- Month 6 | 1.93 score on a scale | Standard Deviation 0.59 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q6- Baseline | 1.73 score on a scale | Standard Deviation 0.8 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q6- Month 6 | 1.67 score on a scale | Standard Deviation 0.49 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q7- Baseline | 2.13 score on a scale | Standard Deviation 0.92 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q1- Baseline | 1.67 score on a scale | Standard Deviation 0.49 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q1- Month 6 | 1.93 score on a scale | Standard Deviation 0.46 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q2- Baseline | 1.47 score on a scale | Standard Deviation 0.74 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q7- Month 6 | 2.00 score on a scale | Standard Deviation 0.76 |
| Health Information | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q1- Baseline | 1.67 score on a scale | Standard Deviation 0.49 |
| Health Information | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q2- Month 6 | 1.60 score on a scale | Standard Deviation 0.83 |
| Health Information | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q6- Baseline | 1.73 score on a scale | Standard Deviation 0.46 |
| Health Information | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q3- Baseline | 2.13 score on a scale | Standard Deviation 0.52 |
| Health Information | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q2- Baseline | 1.53 score on a scale | Standard Deviation 0.64 |
| Health Information | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q3- Month 6 | 2.13 score on a scale | Standard Deviation 0.52 |
| Health Information | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q6- Month 6 | 1.87 score on a scale | Standard Deviation 0.74 |
| Health Information | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q4- Baseline | 1.80 score on a scale | Standard Deviation 0.56 |
| Health Information | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q1- Month 6 | 1.73 score on a scale | Standard Deviation 0.8 |
| Health Information | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q4- Month 6 | 1.93 score on a scale | Standard Deviation 0.59 |
| Health Information | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q7- Baseline | 2.00 score on a scale | Standard Deviation 0.76 |
| Health Information | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q5- Baseline | 1.93 score on a scale | Standard Deviation 0.59 |
| Health Information | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q7- Month 6 | 1.93 score on a scale | Standard Deviation 0.8 |
| Health Information | Change From Baseline in Frontotemporal Dementia Rating Scale (FTDRS) | Q5- Month 6 | 1.93 score on a scale | Standard Deviation 0.8 |
Primary
Change From Baseline in the Self-Care Inventory (SCI)
30 items scored 0-100. A higher score indicates better self-care. This theoretically-derived instrument has construct validity. The self-care confidence scale is embedded within this instrument.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ViCCY: Health Information + Health Coaching | Change From Baseline in the Self-Care Inventory (SCI) | SCI Maintenance Baseline | 71.4 score on a scale | Standard Deviation 14.1 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in the Self-Care Inventory (SCI) | SCI Monitoring Baseline | 60.5 score on a scale | Standard Deviation 19.8 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in the Self-Care Inventory (SCI) | SCI Management Baseline | 54.6 score on a scale | Standard Deviation 21.2 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in the Self-Care Inventory (SCI) | SCI Monitoring Month 6 | 77.8 score on a scale | Standard Deviation 16.6 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in the Self-Care Inventory (SCI) | SCI Maintenance Month 6 | 80.4 score on a scale | Standard Deviation 12 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in the Self-Care Inventory (SCI) | SCI Confidence Baseline | 66.3 score on a scale | Standard Deviation 20.1 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in the Self-Care Inventory (SCI) | SCI Management Month 6 | 70.7 score on a scale | Standard Deviation 15.6 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in the Self-Care Inventory (SCI) | SCI Confidence Month 6 | 79.6 score on a scale | Standard Deviation 18.7 |
| Health Information | Change From Baseline in the Self-Care Inventory (SCI) | SCI Management Month 6 | 59.4 score on a scale | Standard Deviation 26.9 |
| Health Information | Change From Baseline in the Self-Care Inventory (SCI) | SCI Maintenance Baseline | 66.4 score on a scale | Standard Deviation 18.3 |
| Health Information | Change From Baseline in the Self-Care Inventory (SCI) | SCI Maintenance Month 6 | 68.9 score on a scale | Standard Deviation 14.7 |
| Health Information | Change From Baseline in the Self-Care Inventory (SCI) | SCI Management Baseline | 56.5 score on a scale | Standard Deviation 23.7 |
| Health Information | Change From Baseline in the Self-Care Inventory (SCI) | SCI Confidence Month 6 | 65.3 score on a scale | Standard Deviation 23.5 |
| Health Information | Change From Baseline in the Self-Care Inventory (SCI) | SCI Monitoring Baseline | 64.6 score on a scale | Standard Deviation 25.3 |
| Health Information | Change From Baseline in the Self-Care Inventory (SCI) | SCI Monitoring Month 6 | 64.0 score on a scale | Standard Deviation 24.4 |
| Health Information | Change From Baseline in the Self-Care Inventory (SCI) | SCI Confidence Baseline | 68.1 score on a scale | Standard Deviation 22.3 |
Secondary
Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
CES-D is a valid and reliable scale for detecting caregiver depression in dementia. The scoring is on a likert scale 0: Rarely or none of the time (less than 1 day), 1: Some or a little of the time (1-2 days), 2: Occasionally or a moderate amount of time (3-4 days), and 3: Most or all of the time (5-7 days). Higher scores represent greater depressive symptoms. Total scores can range 0 to 60. A score equal or above a 16 means a person is at risk for clinical depression.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ViCCY: Health Information + Health Coaching | Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) | Baseline | 19.7 score on a scale | Standard Deviation 15.1 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) | Month 6 | 15.3 score on a scale | Standard Deviation 11.3 |
| Health Information | Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) | Baseline | 19.0 score on a scale | Standard Deviation 12.8 |
| Health Information | Change From Baseline in Center for Epidemiologic Studies Depression Scale (CES-D) | Month 6 | 16.6 score on a scale | Standard Deviation 10.4 |
Secondary
Change From Baseline in Neuropsychiatric Inventory
Commonly used scale to evaluate 12 common behaviors in dementia including Delusions, Hallucinations, Agitation/Aggression, Depression, Anxiety, Elation/Euphoria, Apathy/Indifference, Disinhibition, Irritability, Aberrant motor behavior, Sleep and Nighttime Behavior Disorders, Appetite and Eating Disorders. Ratings include the frequency of the occurrence of behaviors (1 = occasionally, 2 = often, 3 = frequently, 4 = very frequently), and the level of severity of behaviors (1 = mild, 2 = moderate, 3 = severe). The behavioral domain total score is the product of the frequency score multiplied by the severity score for that behavior. The NPI total score is the sum of all the individual behavioral domains. Scores range from 0-144. Higher scores demonstrate greater symptoms frequency and severity.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ViCCY: Health Information + Health Coaching | Change From Baseline in Neuropsychiatric Inventory | Month 6 | 14.6 score on a scale | Standard Deviation 8.2 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Neuropsychiatric Inventory | Baseline | 20.4 score on a scale | Standard Deviation 15.7 |
| Health Information | Change From Baseline in Neuropsychiatric Inventory | Month 6 | 23.8 score on a scale | Standard Deviation 15.4 |
| Health Information | Change From Baseline in Neuropsychiatric Inventory | Baseline | 23.4 score on a scale | Standard Deviation 17.3 |
Secondary
Change From Baseline in Perceived Stress Scale
The Perceived Stress Scale is a 14-item instrument that provides a global rating of an individual's belief in the severity and frequency of stressful experiences during the last month. The Perceived Stress Scale includes 14 items designed to assess symptoms of stress and global measures of the degree of stress experienced in the past month. Each item is scored from 0 (never) to 4 (very often), with total sum scores ranging from 0 to 56; higher scores indicate higher perceived stress.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ViCCY: Health Information + Health Coaching | Change From Baseline in Perceived Stress Scale | Baseline | 23.1 score on a scale | Standard Deviation 10 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Perceived Stress Scale | Month 6 | 23.4 score on a scale | Standard Deviation 12.4 |
| Health Information | Change From Baseline in Perceived Stress Scale | Baseline | 29.2 score on a scale | Standard Deviation 8.7 |
| Health Information | Change From Baseline in Perceived Stress Scale | Month 6 | 28.4 score on a scale | Standard Deviation 8.3 |
Secondary
Change From Baseline in Ways of Coping Questionnaire, Short Form
This 42-item questionnaire measures the use of five different coping styles: avoidance, problem-focused, seeking social support, self-blame, and wishful thinking. The original scale has been used widely since developed by Lazarus in 1985. The short version (30 items) uses a 4-point Likert-scale response format (0 = not used to 3 = used a great deal). Scores range from 0-90 with higher scores indicating greater coping. It is reliable (alpha 0.95) and has construct validity. This instrument has been used numerous times in studies with older adult caregivers.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ViCCY: Health Information + Health Coaching | Change From Baseline in Ways of Coping Questionnaire, Short Form | Baseline | 22.7 score on a scale | Standard Deviation 16 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Ways of Coping Questionnaire, Short Form | Month 6 | 23.4 score on a scale | Standard Deviation 15.9 |
| Health Information | Change From Baseline in Ways of Coping Questionnaire, Short Form | Baseline | 20.4 score on a scale | Standard Deviation 15 |
| Health Information | Change From Baseline in Ways of Coping Questionnaire, Short Form | Month 6 | 19.1 score on a scale | Standard Deviation 14.6 |
Secondary
Change From Baseline in Zarit Burden Interview (ZBI)
The ZBI has been used in numerous informal dementia caregiver studies to capture burden associated with providing care to a loved one. Total scores are summed and a range is provided for little to no burden (0-21) to severe burden (61-88).
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ViCCY: Health Information + Health Coaching | Change From Baseline in Zarit Burden Interview (ZBI) | Baseline | 38.4 score on a scale | Standard Deviation 11.4 |
| ViCCY: Health Information + Health Coaching | Change From Baseline in Zarit Burden Interview (ZBI) | Month 6 | 39.3 score on a scale | Standard Deviation 14.9 |
| Health Information | Change From Baseline in Zarit Burden Interview (ZBI) | Baseline | 43.6 score on a scale | Standard Deviation 13.6 |
| Health Information | Change From Baseline in Zarit Burden Interview (ZBI) | Month 6 | 46.3 score on a scale | Standard Deviation 12.8 |