Caregiver Stress Syndrome
Conditions
Keywords
Dementia family caregiver, Online education
Brief summary
This study will test a prototype pandemic caregiver training and education course designed for caregivers of persons living with dementia (PLWD). Participants will be randomized to take the course immediately or to take the course after completion of an 8-week waiting period.
Detailed description
Family caregivers, the backbone of care for the upwards of 7 million community-dwelling individuals living with Alzheimer's disease in the U.S., provide at least 85% of the care these individuals receive, at some risk to their own well-being, and are instrumental in navigating healthcare systems. Without their care, it is almost certain that persons living with dementia (PLWD) would have much higher rates of acute and emergency care use than their age-matched peers, perilous venues for them in the best of times, potentially deadly during this pandemic. With coronavirus disease 2019 (COVID-19) restrictions, the amount of care they provide and the expertise needed to provide the care will increase. Typically, caregivers are strangers in healthcare and pandemic landscapes, but they are now called on to enact home care and safety measures and navigate an intricate, complex, and opaque system without the benefit of a compass or a translator, and largely without understanding their role in or having the skills for navigating the system. A variety of interventions have demonstrated benefit in enhancing caregivers' caregiving capacities, with resulting positive outcomes for both caregivers and care recipients. Only a few of these useful interventions, Tele-Savvy among them, have employed distance delivery means, thus enabling rural caregivers and others precluded by circumstance from attending in-person programs to take part in the intervention programs. The study will assess a psychoeducational intervention for dementia caregivers. Participating caregivers will be randomized to immediately enroll in the study intervention or to be in a waitlist group that will begin the intervention 8 weeks later. Participants will complete interviews at baseline and after the 8-week study period.
Interventions
BEHAVIORALPsychoeducational Intervention
The intervention is an online course providing education and training to caregivers over an 8 week period. The self-paced course provides information on caregiving for a PLWD during a pandemic, navigating the health care system for a PLWD, and managing daily life (including self-care).
Sponsors
National Institute on Aging (NIA)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Providing care for a family member or friend with a confirmed diagnosis of dementia * Lives in the community * Co-resides with the PLWD * Is the main caregiver for the PLWD * Has access to a computer with internet service * Can read and understand English
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Center for Epidemiologic Studies - Depression (CES-D) Scale Score | Baseline, Week 8 | The CES-D is a 20-item self-report instrument asking respondents if they have experienced symptoms of depression during the past week. Responses are given on a scale of 0 to 3 where rarely is scored as 0 and most of the time is scored as 3. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression. |
| State-Trait Anxiety Inventory (STAI) Score | Baseline, Week 8 | The STAI is a 20-item self-report scale of positive and negative anxiety experiences. Responses are given on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety. |
| Perceived Stress Scale (PSS-14) Score | Baseline, Week 8 | The Perceived Stress Scale includes 14 items assessing self-reported caregiving stress. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 56 and higher values indicate greater perceived stress. |
| Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score | Baseline, Week 8 | The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate how frequently problems have occurred on a 5-point scale where 0 = never occurred and 4 = daily or more often. Total frequency scores range from 0 to 96 with higher scores indicating greater frequency of memory and behavior problems exhibited by the person living with dementia (PLWD). |
| Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score | Baseline, Week 8 | The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate the degree to which problems have bothered or upset them on a 5-point scale where 0 = not at all and 4 = extremely. Total reaction scores range from 0 to 96 with higher scores indicating more bothered or upset by memory and behavior problems exhibited by the PLWD. |
| Zarit Burden Interview Score | Baseline, Week 8 | The Zarit Burden Interview is a 22-item scale of objective and subjective caregiver burden. Responses are given on a 5-point scale where 0 = never and 4 = nearly always. Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened with providing care. |
| Caregiver Mastery Scales - Competency Score | Baseline, Week 8 | The Caregiving Mastery instrument assesses caregiver mastery of 3 different realms of caregiving situations: Relational Deprivation, Caregiving Competence, and Management of Situation. The Caregiving Competence section includes 4 items are responded to on a 4-point scale where 1 = not at all and 4 = completely. Total scores range from 4 to 16 where higher scores indicate greater feelings of mastery of caregiving. |
| Caregiver Assessment of Behavioral Skill - Self-report Score | Baseline, Week 8 | The Caregiver Assessment of Behavioral Skill - Self-report instrument is a 17-item caregiver self-assessment of perceived capacity to manage care situations. Responses are given on a 3-point scale where 0 = seldom true and 3 = true most of the time, for behaviors exhibited by or relevant to the PLWD. Total scores range from 0 to 51 where higher scores indicate perceived ability to manage providing care. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Psychoeducational Intervention Immediately Caregivers receiving the psychoeducational intervention immediately. | 50 |
| Psychoeducational Intervention After Waiting Period Caregivers receiving the psychoeducational intervention after a waiting period of 8 weeks. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Total | Psychoeducational Intervention After Waiting Period | Psychoeducational Intervention Immediately |
|---|---|---|---|
| Age, Continuous | 64.515 years STANDARD_DEVIATION 10.451 | 63.800 years STANDARD_DEVIATION 11.772 | 65.245 years STANDARD_DEVIATION 8.971 |
| Age of Person Cared For | 78.253 years STANDARD_DEVIATION 8.208 | 78.560 years STANDARD_DEVIATION 7.077 | 77.939 years STANDARD_DEVIATION 9.286 |
| Also Provide Care to Others Missing response | 1 Participants | 0 Participants | 1 Participants |
| Also Provide Care to Others No | 53 Participants | 28 Participants | 25 Participants |
| Also Provide Care to Others Yes | 46 Participants | 22 Participants | 24 Participants |
| Amount of Help From Friends and Family A great deal of help | 19 Participants | 11 Participants | 8 Participants |
| Amount of Help From Friends and Family A little help | 16 Participants | 10 Participants | 6 Participants |
| Amount of Help From Friends and Family Almost no help | 1 Participants | 1 Participants | 0 Participants |
| Amount of Help From Friends and Family Missing response | 41 Participants | 16 Participants | 25 Participants |
| Amount of Help From Friends and Family Not much help | 4 Participants | 2 Participants | 2 Participants |
| Amount of Help From Friends and Family Some help | 19 Participants | 10 Participants | 9 Participants |
| Amount of Strife A main source of difficulties | 4 Participants | 4 Participants | 0 Participants |
| Amount of Strife Hardly any problems | 37 Participants | 21 Participants | 16 Participants |
| Amount of Strife Missing response | 1 Participants | 0 Participants | 1 Participants |
| Amount of Strife Occasional Strife | 22 Participants | 11 Participants | 11 Participants |
| Amount of Strife Some serious difficulties | 8 Participants | 2 Participants | 6 Participants |
| Amount of Strife They have only been helpful | 28 Participants | 12 Participants | 16 Participants |
| Care Provided for Spouse No | 52 Participants | 27 Participants | 25 Participants |
| Care Provided for Spouse Yes | 48 Participants | 23 Participants | 25 Participants |
| Employed Outside of the Home Missing response | 1 Participants | 0 Participants | 1 Participants |
| Employed Outside of the Home No | 68 Participants | 35 Participants | 33 Participants |
| Employed Outside of the Home Yes | 31 Participants | 15 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants | 45 Participants | 48 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Geographic Area of Residence Missing response | 1 Participants | 0 Participants | 1 Participants |
| Geographic Area of Residence Rural | 15 Participants | 5 Participants | 10 Participants |
| Geographic Area of Residence Suburban | 52 Participants | 30 Participants | 22 Participants |
| Geographic Area of Residence Urban | 32 Participants | 15 Participants | 17 Participants |
| Highest Education Level College graduate | 30 Participants | 16 Participants | 14 Participants |
| Highest Education Level Graduate degree | 47 Participants | 26 Participants | 21 Participants |
| Highest Education Level High school/General Educational Development (GED) certificate | 1 Participants | 0 Participants | 1 Participants |
| Highest Education Level Missing response | 1 Participants | 0 Participants | 1 Participants |
| Highest Education Level Some college | 21 Participants | 8 Participants | 13 Participants |
| Person Cared for Diagnosed with Dementia Missing response | 1 Participants | 0 Participants | 1 Participants |
| Person Cared for Diagnosed with Dementia No | 8 Participants | 3 Participants | 5 Participants |
| Person Cared for Diagnosed with Dementia Yes | 91 Participants | 47 Participants | 44 Participants |
| Race/Ethnicity, Customized African American/Black | 15 Participants | 7 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Missing response/did not wish to answer | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 80 Participants | 40 Participants | 40 Participants |
| Region of Enrollment United States | 100 Participants | 50 Participants | 50 Participants |
| Reside in Same House as Person Receiving Care Missing response | 1 Participants | 0 Participants | 1 Participants |
| Reside in Same House as Person Receiving Care No | 21 Participants | 12 Participants | 9 Participants |
| Reside in Same House as Person Receiving Care Yes | 78 Participants | 38 Participants | 40 Participants |
| Sex/Gender, Customized Female | 82 Participants | 40 Participants | 42 Participants |
| Sex/Gender, Customized Male | 16 Participants | 10 Participants | 6 Participants |
| Sex/Gender, Customized Missing response | 2 Participants | 0 Participants | 2 Participants |
| Sexual Orientation Bisexual | 1 Participants | 1 Participants | 0 Participants |
| Sexual Orientation Gay | 0 Participants | 0 Participants | 0 Participants |
| Sexual Orientation Heterosexual | 45 Participants | 23 Participants | 22 Participants |
| Sexual Orientation Lesbian | 1 Participants | 0 Participants | 1 Participants |
| Sexual Orientation Missing response | 53 Participants | 26 Participants | 27 Participants |
| Stage of Dementia of Person Cared For Early Stage - A person may function independently but is having memory lapses | 10 Participants | 5 Participants | 5 Participants |
| Stage of Dementia of Person Cared For Late Stage - loses ability to respond with environment/needs extensive help with daily activities | 16 Participants | 9 Participants | 7 Participants |
| Stage of Dementia of Person Cared For Middle Stage - greater difficulty performing tasks but still remembers significant life details | 65 Participants | 33 Participants | 32 Participants |
| Stage of Dementia of Person Cared For No known diagnosis of dementia | 9 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Caregiver Assessment of Behavioral Skill - Self-report Score
The Caregiver Assessment of Behavioral Skill - Self-report instrument is a 17-item caregiver self-assessment of perceived capacity to manage care situations. Responses are given on a 3-point scale where 0 = seldom true and 3 = true most of the time, for behaviors exhibited by or relevant to the PLWD. Total scores range from 0 to 51 where higher scores indicate perceived ability to manage providing care.
Time frame: Baseline, Week 8
Population: This analysis includes participants who attended the indicated study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychoeducational Intervention | Caregiver Assessment of Behavioral Skill - Self-report Score | Baseline | 14.3 score on a scale | Standard Deviation 5.9 |
| Psychoeducational Intervention | Caregiver Assessment of Behavioral Skill - Self-report Score | Week 8 | 14.1 score on a scale | Standard Deviation 6.7 |
| Waitlist Control Group | Caregiver Assessment of Behavioral Skill - Self-report Score | Baseline | 15.1 score on a scale | Standard Deviation 5.7 |
| Waitlist Control Group | Caregiver Assessment of Behavioral Skill - Self-report Score | Week 8 | 14.4 score on a scale | Standard Deviation 4.9 |
Primary
Caregiver Mastery Scales - Competency Score
The Caregiving Mastery instrument assesses caregiver mastery of 3 different realms of caregiving situations: Relational Deprivation, Caregiving Competence, and Management of Situation. The Caregiving Competence section includes 4 items are responded to on a 4-point scale where 1 = not at all and 4 = completely. Total scores range from 4 to 16 where higher scores indicate greater feelings of mastery of caregiving.
Time frame: Baseline, Week 8
Population: This analysis includes participants who attended the indicated study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychoeducational Intervention | Caregiver Mastery Scales - Competency Score | Baseline | 12.9 score on a scale | Standard Deviation 1.8 |
| Psychoeducational Intervention | Caregiver Mastery Scales - Competency Score | Week 8 | 13.4 score on a scale | Standard Deviation 1.6 |
| Waitlist Control Group | Caregiver Mastery Scales - Competency Score | Baseline | 12.5 score on a scale | Standard Deviation 1.9 |
| Waitlist Control Group | Caregiver Mastery Scales - Competency Score | Week 8 | 12.6 score on a scale | Standard Deviation 1.7 |
Primary
Center for Epidemiologic Studies - Depression (CES-D) Scale Score
The CES-D is a 20-item self-report instrument asking respondents if they have experienced symptoms of depression during the past week. Responses are given on a scale of 0 to 3 where rarely is scored as 0 and most of the time is scored as 3. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression.
Time frame: Baseline, Week 8
Population: This analysis includes participants who attended the indicated study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychoeducational Intervention | Center for Epidemiologic Studies - Depression (CES-D) Scale Score | Baseline | 11.7 score on a scale | Standard Deviation 8.8 |
| Psychoeducational Intervention | Center for Epidemiologic Studies - Depression (CES-D) Scale Score | Week 8 | 10.4 score on a scale | Standard Deviation 8.7 |
| Waitlist Control Group | Center for Epidemiologic Studies - Depression (CES-D) Scale Score | Baseline | 11.8 score on a scale | Standard Deviation 8 |
| Waitlist Control Group | Center for Epidemiologic Studies - Depression (CES-D) Scale Score | Week 8 | 14.6 score on a scale | Standard Deviation 9.6 |
Primary
Perceived Stress Scale (PSS-14) Score
The Perceived Stress Scale includes 14 items assessing self-reported caregiving stress. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 56 and higher values indicate greater perceived stress.
Time frame: Baseline, Week 8
Population: This analysis includes participants who attended the indicated study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychoeducational Intervention | Perceived Stress Scale (PSS-14) Score | Baseline | 22.3 score on a scale | Standard Deviation 7.9 |
| Psychoeducational Intervention | Perceived Stress Scale (PSS-14) Score | Week 8 | 21.7 score on a scale | Standard Deviation 7.1 |
| Waitlist Control Group | Perceived Stress Scale (PSS-14) Score | Baseline | 22.4 score on a scale | Standard Deviation 7.3 |
| Waitlist Control Group | Perceived Stress Scale (PSS-14) Score | Week 8 | 23.1 score on a scale | Standard Deviation 8.1 |
Primary
Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score
The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate how frequently problems have occurred on a 5-point scale where 0 = never occurred and 4 = daily or more often. Total frequency scores range from 0 to 96 with higher scores indicating greater frequency of memory and behavior problems exhibited by the person living with dementia (PLWD).
Time frame: Baseline, Week 8
Population: This analysis includes participants who attended the indicated study visits and who provided complete information for the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychoeducational Intervention | Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score | Baseline | 39.3 score on a scale | Standard Deviation 11 |
| Psychoeducational Intervention | Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score | Week 8 | 39.0 score on a scale | Standard Deviation 11.8 |
| Waitlist Control Group | Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score | Baseline | 40.1 score on a scale | Standard Deviation 12.4 |
| Waitlist Control Group | Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score | Week 8 | 38.2 score on a scale | Standard Deviation 13.4 |
Primary
Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate the degree to which problems have bothered or upset them on a 5-point scale where 0 = not at all and 4 = extremely. Total reaction scores range from 0 to 96 with higher scores indicating more bothered or upset by memory and behavior problems exhibited by the PLWD.
Time frame: Baseline, Week 8
Population: This analysis includes participants who attended the indicated study visits and who provided complete information for the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychoeducational Intervention | Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score | Baseline | 15.3 score on a scale | Standard Deviation 8.9 |
| Psychoeducational Intervention | Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score | Week 8 | 14.9 score on a scale | Standard Deviation 9 |
| Waitlist Control Group | Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score | Baseline | 16.3 score on a scale | Standard Deviation 11.7 |
| Waitlist Control Group | Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score | Week 8 | 16.3 score on a scale | Standard Deviation 14.1 |
Primary
State-Trait Anxiety Inventory (STAI) Score
The STAI is a 20-item self-report scale of positive and negative anxiety experiences. Responses are given on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety.
Time frame: Baseline, Week 8
Population: This analysis includes participants who attended the indicated study visits and who provided complete information for the survey.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychoeducational Intervention | State-Trait Anxiety Inventory (STAI) Score | Baseline | 29.7 score on a scale | Standard Deviation 8.5 |
| Psychoeducational Intervention | State-Trait Anxiety Inventory (STAI) Score | Week 8 | 32.6 score on a scale | Standard Deviation 10.4 |
| Waitlist Control Group | State-Trait Anxiety Inventory (STAI) Score | Baseline | 33.7 score on a scale | Standard Deviation 9.1 |
| Waitlist Control Group | State-Trait Anxiety Inventory (STAI) Score | Week 8 | 38.2 score on a scale | Standard Deviation 12.5 |
Primary
Zarit Burden Interview Score
The Zarit Burden Interview is a 22-item scale of objective and subjective caregiver burden. Responses are given on a 5-point scale where 0 = never and 4 = nearly always. Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened with providing care.
Time frame: Baseline, Week 8
Population: This analysis includes participants who attended the indicated study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychoeducational Intervention | Zarit Burden Interview Score | Baseline | 33.9 score on a scale | Standard Deviation 12.6 |
| Psychoeducational Intervention | Zarit Burden Interview Score | Week 8 | 33.1 score on a scale | Standard Deviation 13.1 |
| Waitlist Control Group | Zarit Burden Interview Score | Baseline | 37.9 score on a scale | Standard Deviation 14.1 |
| Waitlist Control Group | Zarit Burden Interview Score | Week 8 | 39.0 score on a scale | Standard Deviation 13.2 |