Caregiver Burnout, Dementia
Conditions
Keywords
People Living With Disability, PLWD, Caregiver, Interventionist, Distance education, Savvy
Brief summary
The study goal is to develop a web-based system that uses distance education methods and provides manuals and protocols to train, certify, and monitor the performance of interventionists to deliver the Savvy Caregiver program (Savvy), an evidence-based dementia family caregiver psychoeducation program. The system has a potential to increase the scalability of Savvy.
Detailed description
The number of People Living With Disability (PLWD) in the U.S. will rise from 5.7 million to 14 million by 2050, and the number of family caregivers who maintain these persons in the community will rise proportionately from 15 million at present. Several psychoeducation programs, including Savvy, have successfully ameliorated the adverse effects of caregiving, but these programs are only minimally available and accessible. The study goal is to develop a web-based system that uses distance education methods and provides manuals and protocols to train, certify, and monitor the performance of interventionists to deliver the Savvy Caregiver program (Savvy), an evidence-based dementia family caregiver psychoeducation program. The system has a potential to increase the scalability of Savvy.
Interventions
BEHAVIORALSavvy program
Caregiver program (Savvy) is an evidence-based dementia family caregiver psychoeducation program. Provided to groups of 8-12 (typically) individuals caring for family members living with Alzheimer's disease or related dementias (PLWD), Savvy employs a mechanism of action based in Social Cognitive theory to promote caregivers' solution-focused coping behaviors through the acquisition of appropriate knowledge, skills, and outlook and the enhancement of caregiving mastery.
BEHAVIORALSemi-structured video interviews
Semi-structured video interviews will assess the preliminary efficacy of programs led by system-trained interventionists in producing anticipated outcomes in caregiver participants - reduced depression and burden and enhanced caregiving mastery. It will also focus on sense of the completeness and adequacy of the training program, including the training methods, videos, and materials
Sponsors
National Institute on Aging (NIA)
Emory University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Organizational Leaders 1. Able to understand and speak English 2. Affiliated with an organization serving caregivers for family members living with Alzheimer's disease or related dementias 3. 18 years or older Interventionists 1. Able to understand and speak English 2. Affiliated with a participating organization 3. 18 years or older Caregivers 1. Able to understand and speak English 2. Caregiver for a person living with Alzheimer's disease or related dementias (PLWD) who is providing informal care for at least 3 hours a day. PLWD should not be bound for institutional care within the next 6 months. 3. 18 years or older
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score | Baseline, Month 6 | The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week. It includes 20 items comprising six scales reflecting major facets of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Score | Baseline, Month 6 | State-Trait Anxiety Inventory scale - 20-item 4-point Likert scale is sensitive to changes in transitory anxiety. State anxiety items include: I am tense; I am worried and I feel calm; I feel secure. Trait anxiety items include: I worry too much over something that really doesn't matter and I am content; I am a steady person. All items are rated on a 4-point scale (e.g., from Almost Never (0) to Almost Always (3)); Range: 0-60. Higher scores indicate greater anxiety. |
| Change in Zarit Burden Inventory (ZBI) Score | Baseline, Month 6 | Zarit Burden Inventory (ZBI) score is a 22-item Likert scale. Each item is a statement which the caregiver is asked to endorse using a 5-point scale, scored Never (0) to Nearly Always (4); Range: 0-88. Total score is obtained by summing all items endorsed. Higher scores indicate greater perceived burden. |
| Change in Caregiver Pearlin Mastery Score | Baseline, Month 6 | The Pearlin Mastery (PM) scale measures the extent to which an individual regards their life chances as being under their personal control rather than fatalistically ruled. Response options: 4-point Likert scale, 1,Strongly disagree and 4,Strongly agree. Items are summed, yielding a range from 7 to 28. Higher scores indicate greater levels of mastery. |
| Change in Revised Memory and Behavior Problem Checklist Score | Baseline, 6 months | Revised Memory and Behavior Problem Checklist is a 24-item two-part Likert scale that assesses (Part 1) caregiver reported frequency of patient behaviors and (Part 2) caregiver's responreaction to each behavior, or the extent of distress experienced. The frequency of behaviors is assessed based on a Likert-scale of 0 to (0 = never occurs, 1 = occurs infrequently and not in the last week, 2 = occurred 1-2 times in the last week, 3 = occurred 3-6 times in the last week, and 4 = occurs daily or more often); Range: 0-96. Reactions are assessed by asking how upsetting the behavior was on a Likert scale of 0 to 4 (0 = Not at all, 1= a little, 2 = moderately, 3 = very much, and 4 =extremely); Range: 0-96. The two parts of the scale yield a summary score - higher scores indicate higher frequency of patient behaviors and greater levels of caregiver distress, respectively. |
Countries
United States
Participant flow
Recruitment details
120 family caregivers who took part in Savvy Caregiver programs led by interventionists trained by the online training program developed in this project consented to be part of the study and provided baseline data. These caregivers were recruited from 37 Savvy Caregiver programs offered by 23 of the trained interventionists from 13 agencies located in 5 states. The first caregiver enrolled on 8/04/21. The last caregiver data collection point occurred on 09/27/2023
Participants by arm
| Arm | Count |
|---|---|
| Savvy Participants Using an on-line survey method, each caregiver will be asked to complete the post-program fidelity monitoring survey that seeks responses to the program (feel more knowledgeable, more competent, better equipped, etc.) and asks them to assess the interventionist's performance and verify that certain key elements of the program were covered.
Savvy program: Caregiver program (Savvy) is an evidence-based dementia family caregiver psychoeducation program. Provided to groups of 8-12 (typically) individuals caring for family members living with Alzheimer's disease or related dementias (PLWD), Savvy employs a mechanism of action based in Social Cognitive theory to promote caregivers' solution-focused coping behaviors through the acquisition of appropriate knowledge, skills, and outlook and the enhancement of caregiving mastery. | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 41 |
Baseline characteristics
| Characteristic | Savvy Participants |
|---|---|
| Age, Customized Age 33- 83 | 67.9 years STANDARD_DEVIATION 9.4 |
| Any other help with caregiving: Yes | 75 Participants |
| Employed outside home: No | 88 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 111 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Live with PLWD: Yes | 91 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 105 Participants |
| Relationship to PLWD (People living with Dementia) Child/ Other Relative | 43 Participants |
| Relationship to PLWD (People living with Dementia) Sibling/ Friend/ Other | 7 Participants |
| Relationship to PLWD (People living with Dementia) Spouse | 70 Participants |
| Sex: Female, Male Female | 98 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 120 |
| other Total, other adverse events | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 |
Outcome results
Primary
Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score
The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week. It includes 20 items comprising six scales reflecting major facets of depression: depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Time frame: Baseline, Month 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Savvy Participants | Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score | Baseline | 13.2 score on a scale | Standard Deviation 9.1 |
| Savvy Participants | Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score | Month 6 | 79 score on a scale | Standard Deviation 11 |
Secondary
Change in Anxiety Score
State-Trait Anxiety Inventory scale - 20-item 4-point Likert scale is sensitive to changes in transitory anxiety. State anxiety items include: I am tense; I am worried and I feel calm; I feel secure. Trait anxiety items include: I worry too much over something that really doesn't matter and I am content; I am a steady person. All items are rated on a 4-point scale (e.g., from Almost Never (0) to Almost Always (3)); Range: 0-60. Higher scores indicate greater anxiety.
Time frame: Baseline, Month 6
Population: The analysis population includes participants who completed the required assessment at follow-up appointments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Savvy Participants | Change in Anxiety Score | Baseline | 34.9 score on a scale | Standard Deviation 10.2 |
| Savvy Participants | Change in Anxiety Score | Month 6 | 35.3 score on a scale | Standard Deviation 11.5 |
Secondary
Change in Caregiver Pearlin Mastery Score
The Pearlin Mastery (PM) scale measures the extent to which an individual regards their life chances as being under their personal control rather than fatalistically ruled. Response options: 4-point Likert scale, 1,Strongly disagree and 4,Strongly agree. Items are summed, yielding a range from 7 to 28. Higher scores indicate greater levels of mastery.
Time frame: Baseline, Month 6
Population: The analysis population includes participants who completed the required assessment at follow-up appointments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Savvy Participants | Change in Caregiver Pearlin Mastery Score | Baseline | 11.5 score on a scale | Standard Deviation 2.1 |
| Savvy Participants | Change in Caregiver Pearlin Mastery Score | Month 6 | 12.7 score on a scale | Standard Deviation 1.6 |
Secondary
Change in Revised Memory and Behavior Problem Checklist Score
Revised Memory and Behavior Problem Checklist is a 24-item two-part Likert scale that assesses (Part 1) caregiver reported frequency of patient behaviors and (Part 2) caregiver's responreaction to each behavior, or the extent of distress experienced. The frequency of behaviors is assessed based on a Likert-scale of 0 to (0 = never occurs, 1 = occurs infrequently and not in the last week, 2 = occurred 1-2 times in the last week, 3 = occurred 3-6 times in the last week, and 4 = occurs daily or more often); Range: 0-96. Reactions are assessed by asking how upsetting the behavior was on a Likert scale of 0 to 4 (0 = Not at all, 1= a little, 2 = moderately, 3 = very much, and 4 =extremely); Range: 0-96. The two parts of the scale yield a summary score - higher scores indicate higher frequency of patient behaviors and greater levels of caregiver distress, respectively.
Time frame: Baseline, 6 months
Population: The analysis population includes participants who completed the required assessment at follow-up appointments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Savvy Participants | Change in Revised Memory and Behavior Problem Checklist Score | Baseline Frequency | 38.7 score on a scale | Standard Deviation 12.2 |
| Savvy Participants | Change in Revised Memory and Behavior Problem Checklist Score | Month 6 Frequency | 36.6 score on a scale | Standard Deviation 11.8 |
| Savvy Participants | Change in Revised Memory and Behavior Problem Checklist Score | Baseline Reaction | 19.7 score on a scale | Standard Deviation 11.9 |
| Savvy Participants | Change in Revised Memory and Behavior Problem Checklist Score | Month 6 Reaction | 17.0 score on a scale | Standard Deviation 11 |
Secondary
Change in Zarit Burden Inventory (ZBI) Score
Zarit Burden Inventory (ZBI) score is a 22-item Likert scale. Each item is a statement which the caregiver is asked to endorse using a 5-point scale, scored Never (0) to Nearly Always (4); Range: 0-88. Total score is obtained by summing all items endorsed. Higher scores indicate greater perceived burden.
Time frame: Baseline, Month 6
Population: The analysis population includes participants who completed the required assessment at follow-up appointments.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Savvy Participants | Change in Zarit Burden Inventory (ZBI) Score | Baseline | 35.9 score on a scale | Standard Deviation 14.2 |
| Savvy Participants | Change in Zarit Burden Inventory (ZBI) Score | Month 6 | 35.2 score on a scale | Standard Deviation 13.4 |