Caregivers Burnout, Frontotemporal Dementia
Conditions
Brief summary
Much effort over the last several decades has been devoted to developing and implementing psychoeducational interventions for family caregiving partners for those with Alzheimer's and relatedm dementias (ADRD). However, few interventions address the specific needs of care partners for those with frontotemporal degeneration (FTD). This study tests an intervention to support family caregivers for those with FTD.
Detailed description
Much effort over the last several decades has been devoted to developing and implementing psychoeducational interventions for family caregiving partners for those with Alzheimer's and related dementias (ADRD). However, few interventions address the specific needs of care partners for those with frontotemporal degeneration (FTD), the most common form of dementia in adults under age 60. Caring for a family member with FTD can affect the psychological, social, and relational health of families. Care partners for those with the disease have higher levels of burden and depression, as well as more sleep disturbances and worse financial strain than care partners for those with ADRD. Psychoeducational interventions can alleviate some of the psychological symptoms associated with dementia caregiving, but few programs have been designed for care partners for persons with FTD. Further, many of the existing programs are inaccessible for families due to distance and cost. The STELLA (Support via TEchnology: Living and Learning with Advancing dementia) intervention is designed to teach ADRD care partners strategies for managing behavioral symptoms associated with dementia. STELLA uses videoconferencing to connect care partners, in their own homes, with experienced Guides (e.g., nurses). The Guides use cognitive behavioral techniques to assist care partners in identifying and implementing strategies to reduce distressing behavioral symptoms in the person with dementia. Our pilot work found that early versions of STELLA reduced the frequency of behavioral symptoms and care partner reactivity to them. In this study, the investigators will adapt STELLA to specifically address the needs of family care partners for persons with frontotemporal degeneration. Aim 1. Adapt STELLA to the needs of care partners for those with FTD 1. Gather FTD care partner feedback on STELLA and suggestions for tailoring STELLA for FTD 2. Adapt STELLA for FTD care partners based on end-user feedback Aim 2. Assess the feasibility, acceptability and STELLA-FTD with FTD care partners Aim 3. Assess the preliminary efficacy of STELLA-FTD on the primary outcomes: reducing the frequency of behavioral symptoms and care partner reactivity to the symptoms as measured on the Revised Memory and Behavior Problems Checklist (RMBPC).
Interventions
OTHERSTELLA-FTD
Behavioral intervention for caregivers for those with FTD
Sponsors
The Association for Frontotemporal Degeneration
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
8-week single group intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Care Partner for family member, close friend or kin with FTD, primary progressive aphasia, progressive supranuclear palsy or other frontotemporal degenerative dementia * Must speak English * Must be able to see and hear the videoconference-based interactions.
Exclusion criteria
\- Family member does not care for someone with FTD conditions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revised Memory and Behavior Problems Checklist (RMBPC) | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) | The primary outcome variable, reactivity, will be assessed with the RMBPC, which measures the frequency of care recipient behavioral symptoms and care partner reactions to these behaviors. The RMBPC was chosen because it aligns with our theoretical foundation that assumes burden is a result of care partner reactions to behavioral symptoms. The RMBPC is a 29-item caregiver report measure, 5-point Likert scale with frequency measuring from 0 (never occurred) to 4 (daily or more often) and reactivity measuring from 0 (not at all) to 4 (extremely) for a total score between 0-116 for each subscale (frequency subscale and reactivity subscale). Higher scores indicate greater behavioral problems. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Family Caregiver Self-Efficacy Scale | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) | Measures caregiver self-efficacy for symptoms management and community support service use. Scale 10-100, higher scores indicating better sense of self-efficacy. |
| Center for Epidemiologic Studies Depression | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) | This is a 10-item scale that measures depression; the range is 0 (no depression) to 30 (severe depression). |
| Marwit Meuser Caregiver Grief Index | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) | Caregiver grief; Scale 18-90, higher scores=worse grief |
| Caregiver Guilt Questionnaire (CGQ) | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) | The CGQ is a 22-item caregiver report measure, 5-point Likert scale designed to measure guilt in caregivers with response options from 0 (never) to 4 (always or almost always). Items are organized into five main subscales that are scored by computing the sum of the scores of the items belonging to the corresponding scale. Guilt about doing wrong by the care recipient includes 7 items with a score range of 0-28. Guilt about failing to meet the challenges of caregiving includes 6 items with item #6 being reverse scored. The score ranges from 0-24. Guilt about self-care includes 4 items with a score range of 0-16. Guilt about neglecting other relatives includes 2 items with a score range of 0-8. Guilt about having negative feelings towards other people includes 3 items with a score range of 0-12. The total score on the CGQ consists of the sum of the scores of all the subscales, with a total score ranging from 0-88. A higher total score reflects greater guilt. |
| Quality of Life Alzheimer's Disease, Care Partner | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) | This is a brief, 13-item measure designed specifically to obtain a rating of the caregiver's Quality of Life. The measure focuses on quality of life domains. It uses simple and straightforward language and responses & includes assessments of the individual's relationships with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality. The total range is 13 to 52 with lower scores indicating worse quality of life. |
| Ten-Item Personality Inventory (TIPI) | Pre-Intervention (at Week 1) | The Ten-Item Personality Inventory (TIPI) is a 10-item self-report measure of five personality domains: Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness to Experiences. Each item is rated on a 7-point Likert scale ranging from 1 (Disagree strongly) to 7 (Agree strongly). Items 2, 4, 6, 8, and 10 are reverse-scored. For this study, items were summed to create a total personality score. Possible total scores range from 10 to 70, with higher scores indicating stronger endorsement of personality characteristics across the five domains (i.e., higher trait expression). |
| Sleep Hygiene Index | Post-Intervention (at Week 8) | The Sleep Hygiene Index (SHI) is a self-administered questionnaire used to assess an individual's sleep hygiene practices. It's a tool used in research and clinical settings to evaluate sleep habits and identify potential areas for improvement. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (always). Total scores range from 0 to 52, with a higher score representing poorer sleep hygiene. |
| Contact Survey | Post-Intervention (at Week 8) | A 9-item measure to assess whether caregivers contacted other caregivers or not. |
| Experience Survey | Post-Intervention (at Week 8) | Caregiver assessment of program |
Countries
United States
Participant flow
Recruitment details
We were able to recruit 16 participants
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group This group received the STELLA-FTD intervention. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Intervention Group |
|---|---|
| Age, Continuous | 67.4 years STANDARD_DEVIATION 7.61 |
| Diagnosis of Care Recipient Bv-FTD | 7 Participants |
| Diagnosis of Care Recipient PPA | 7 Participants |
| Diagnosis of Care Recipient PSP | 1 Participants |
| Diagnosis of Care Recipient Unknown | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 1 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 16 Participants |
| Rural Status Metropolitan | 14 Participants |
| Rural Status Rural | 2 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Revised Memory and Behavior Problems Checklist (RMBPC)
The primary outcome variable, reactivity, will be assessed with the RMBPC, which measures the frequency of care recipient behavioral symptoms and care partner reactions to these behaviors. The RMBPC was chosen because it aligns with our theoretical foundation that assumes burden is a result of care partner reactions to behavioral symptoms. The RMBPC is a 29-item caregiver report measure, 5-point Likert scale with frequency measuring from 0 (never occurred) to 4 (daily or more often) and reactivity measuring from 0 (not at all) to 4 (extremely) for a total score between 0-116 for each subscale (frequency subscale and reactivity subscale). Higher scores indicate greater behavioral problems.
Time frame: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)
Population: thirteen individuals completed this prior to intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Revised Memory and Behavior Problems Checklist (RMBPC) | Pre intervention, behavior frequency | 28.5 units on a scale | Standard Deviation 15.9 |
| Intervention Group | Revised Memory and Behavior Problems Checklist (RMBPC) | Post intervention, reactivity | 15.8 units on a scale | Standard Deviation 13.5 |
| Intervention Group | Revised Memory and Behavior Problems Checklist (RMBPC) | Post intervention; behavior frequency | 25.2 units on a scale | Standard Deviation 15.3 |
| Intervention Group | Revised Memory and Behavior Problems Checklist (RMBPC) | Pre-intervention, reactivity | 16.6 units on a scale | Standard Deviation 12.9 |
Secondary
Caregiver Guilt Questionnaire (CGQ)
The CGQ is a 22-item caregiver report measure, 5-point Likert scale designed to measure guilt in caregivers with response options from 0 (never) to 4 (always or almost always). Items are organized into five main subscales that are scored by computing the sum of the scores of the items belonging to the corresponding scale. Guilt about doing wrong by the care recipient includes 7 items with a score range of 0-28. Guilt about failing to meet the challenges of caregiving includes 6 items with item #6 being reverse scored. The score ranges from 0-24. Guilt about self-care includes 4 items with a score range of 0-16. Guilt about neglecting other relatives includes 2 items with a score range of 0-8. Guilt about having negative feelings towards other people includes 3 items with a score range of 0-12. The total score on the CGQ consists of the sum of the scores of all the subscales, with a total score ranging from 0-88. A higher total score reflects greater guilt.
Time frame: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)
Population: higher scores=greater guilt
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Caregiver Guilt Questionnaire (CGQ) | Negative feelings post | 1.92 units on a scale | Standard Deviation 2.43 |
| Intervention Group | Caregiver Guilt Questionnaire (CGQ) | Neglecting other relatives, pre | 2.31 units on a scale | Standard Deviation 2.02 |
| Intervention Group | Caregiver Guilt Questionnaire (CGQ) | self care efficacy pre | 4.38 units on a scale | Standard Deviation 3.8 |
| Intervention Group | Caregiver Guilt Questionnaire (CGQ) | Self care efficacy post | 4.77 units on a scale | Standard Deviation 4.21 |
| Intervention Group | Caregiver Guilt Questionnaire (CGQ) | Failing post | 5.85 units on a scale | Standard Deviation 4.88 |
| Intervention Group | Caregiver Guilt Questionnaire (CGQ) | Doing wrong by care recipient pre | 9.46 units on a scale | Standard Deviation 5.72 |
| Intervention Group | Caregiver Guilt Questionnaire (CGQ) | Negative feelings towards others pre | 2.23 units on a scale | Standard Deviation 1.92 |
| Intervention Group | Caregiver Guilt Questionnaire (CGQ) | Neglecting others post | 2.46 units on a scale | Standard Deviation 2.63 |
| Intervention Group | Caregiver Guilt Questionnaire (CGQ) | failing to meet challenges pre | 6 units on a scale | Standard Deviation 4.6 |
| Intervention Group | Caregiver Guilt Questionnaire (CGQ) | Doing wrong post | 10.4 units on a scale | Standard Deviation 6.24 |
Secondary
Center for Epidemiologic Studies Depression
This is a 10-item scale that measures depression; the range is 0 (no depression) to 30 (severe depression).
Time frame: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)
Population: Depression assessed prior to and after study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Center for Epidemiologic Studies Depression | CESD pre | 10.8 units on a scale | Standard Deviation 5.78 |
| Intervention Group | Center for Epidemiologic Studies Depression | CESD post | 11.3 units on a scale | Standard Deviation 6.33 |
Secondary
Contact Survey
A 9-item measure to assess whether caregivers contacted other caregivers or not.
Time frame: Post-Intervention (at Week 8)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group | Contact Survey | Number who did not contact other caregivers | 11 Participants |
| Intervention Group | Contact Survey | Number who contacted others | 2 Participants |
Secondary
Experience Survey
Caregiver assessment of program
Time frame: Post-Intervention (at Week 8)
Population: Count of items
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Group | Experience Survey | Overall, I was satisfied with the STELLA-FTD experience | 13 participants |
| Intervention Group | Experience Survey | It was easy for me to attend | 13 participants |
| Intervention Group | Experience Survey | I could find a safe activity for my family member | 13 participants |
| Intervention Group | Experience Survey | It was easy to connect via Webex | 12 participants |
| Intervention Group | Experience Survey | I had good tech support | 13 participants |
| Intervention Group | Experience Survey | I feel confident that I can use STELLA-FTD skills to manage upsetting behaviors | 13 participants |
| Intervention Group | Experience Survey | I could talk openly with the professionals | 13 participants |
| Intervention Group | Experience Survey | I liked working with other care partners | 13 participants |
| Intervention Group | Experience Survey | I discuss sensitive topics with other care partners | 11 participants |
Secondary
Family Caregiver Self-Efficacy Scale
Measures caregiver self-efficacy for symptoms management and community support service use. Scale 10-100, higher scores indicating better sense of self-efficacy.
Time frame: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Family Caregiver Self-Efficacy Scale | Self-efficacy pre | 61.1 units on a scale | Standard Deviation 18.8 |
| Intervention Group | Family Caregiver Self-Efficacy Scale | Self-efficacy post | 62.8 units on a scale | Standard Deviation 18.3 |
Secondary
Marwit Meuser Caregiver Grief Index
Caregiver grief; Scale 18-90, higher scores=worse grief
Time frame: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)
Population: higher scores=higher grief
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Marwit Meuser Caregiver Grief Index | MMCGI pre | 54.2 units on a scale | Standard Deviation 13.7 |
| Intervention Group | Marwit Meuser Caregiver Grief Index | MMCGI post | 55.3 units on a scale | Standard Deviation 13.7 |
Secondary
Quality of Life Alzheimer's Disease, Care Partner
This is a brief, 13-item measure designed specifically to obtain a rating of the caregiver's Quality of Life. The measure focuses on quality of life domains. It uses simple and straightforward language and responses & includes assessments of the individual's relationships with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality. The total range is 13 to 52 with lower scores indicating worse quality of life.
Time frame: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)
Population: Higher scores= better QoL
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Group | Quality of Life Alzheimer's Disease, Care Partner | QoL, care partners pre | 37.6 units on a scale | Standard Deviation 5.06 |
| Intervention Group | Quality of Life Alzheimer's Disease, Care Partner | QoL, care partners, post | 36.2 units on a scale | Standard Deviation 3.95 |
Secondary
Sleep Hygiene Index
The Sleep Hygiene Index (SHI) is a self-administered questionnaire used to assess an individual's sleep hygiene practices. It's a tool used in research and clinical settings to evaluate sleep habits and identify potential areas for improvement. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (always). Total scores range from 0 to 52, with a higher score representing poorer sleep hygiene.
Time frame: Post-Intervention (at Week 8)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Sleep Hygiene Index | 10.2 units on a scale | Standard Deviation 8.66 |
Secondary
Ten-Item Personality Inventory (TIPI)
The Ten-Item Personality Inventory (TIPI) is a 10-item self-report measure of five personality domains: Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness to Experiences. Each item is rated on a 7-point Likert scale ranging from 1 (Disagree strongly) to 7 (Agree strongly). Items 2, 4, 6, 8, and 10 are reverse-scored. For this study, items were summed to create a total personality score. Possible total scores range from 10 to 70, with higher scores indicating stronger endorsement of personality characteristics across the five domains (i.e., higher trait expression).
Time frame: Pre-Intervention (at Week 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Ten-Item Personality Inventory (TIPI) | 51 units on a scale | Standard Deviation 8.73 |