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| Name | Class |
|---|---|
| The Association for Frontotemporal Degeneration | UNKNOWN |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STELLA-FTD study | Experimental | One group only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STELLA-FTD | Other | Behavioral intervention for caregivers for those with FTD |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
- Family member does not care for someone with FTD conditions.
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| Name | Affiliation | Role |
|---|---|---|
| Allison Lindauer | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37655616 | Result | Lindauer A, Smith S, Gothard S, Mattek N, Tran L, Mooney A. 'There's no straight line...' a consumer-informed intervention for FTD family care partners: the STELLA-FTD pilot study. Aging Ment Health. 2023 Sep-Oct;27(10):2000-2010. doi: 10.1080/13607863.2023.2250741. Epub 2023 Sep 1. |
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Video-recordings and other data from this study may be shared with other investigators for future research studies. A study ID number will be assigned to each participant. Only the investigators and people involved in the conduct of the study will be authorized to link the ID number to the participants. Other investigators who may receive samples of data for research will be given only the ID number which will not identify participants. However, the video-recordings will show participants' faces. Names and any information discussed during the sessions and focus group will be heard in the audio. The faces, names and audio of any other people who enter the camera zone will also be recorded. The information given for this study will be identifiable and will not be private. Participants receive this information on the information sheet.
Data is currently available and will be available indefinitely.
Data is entered in to access-controlled local repository (#6845) and NACC National Repository.
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We were able to recruit 16 participants
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | There is one intervention group that received the STELLA-FTD intervention. The behavioral intervention was provided to participants and outcomes were measured prior to and after the intervention within the same group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | This group received the STELLA-FTD intervention. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | thirteen individuals completed this prior to intervention | Posted | Mean | Standard Deviation | units on a scale | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | This group received the STELLA-FTD intervention. | 0 |
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The small sample size limited our ability to identify the effect of study intervention on burden in this important caregiving cohort. Limits to classic in-person recruitment strategies due to COVID-19 restrictions made personalized recruitment efforts challenging. This was offset by a multimodal online recruitment strategy that targeted care partners across the western United States.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison Lindauer, PhD, APRN | OHSU | 5034944347 | lindauer@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2022 | Jun 4, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D057180 | Frontotemporal Dementia |
| ID | Term |
|---|---|
| D057174 | Frontotemporal Lobar Degeneration |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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8-week single group intervention
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| Pre-intervention (at Week 1) and Post-Intervention (at Week 8) |
| 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. | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) |
| Center for Epidemiologic Studies Depression | This is a 10-item scale that measures depression; the range is 0 (no depression) to 30 (severe depression). | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) |
| Marwit Meuser Caregiver Grief Index | Caregiver grief; Scale 18-90, higher scores=worse grief | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) |
| 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. | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) |
| Experience Survey | Caregiver assessment of program | Post-Intervention (at Week 8) |
| 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). | Pre-Intervention (at Week 1) |
| 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. | Post-Intervention (at Week 8) |
| Contact Survey | A 9-item measure to assess whether caregivers contacted other caregivers or not. | Post-Intervention (at Week 8) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Rural Status | Count of Participants | Participants |
|
| Diagnosis of Care Recipient | Dementia diagnosis of care recipients. BvFTD = Behavioral variant FTD; PPA = Primary progressive aphasia; PSP = Progressive supranuclear palsy. | Count of Participants | Participants |
|
RMBPC prior to STELLA-FTD |
|
|
| 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. | Higher scores= better QoL | Posted | Mean | Standard Deviation | units on a scale | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) |
|
|
|
| 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). | Depression assessed prior to and after study | Posted | Mean | Standard Deviation | units on a scale | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) |
|
|
|
| Secondary | Marwit Meuser Caregiver Grief Index | Caregiver grief; Scale 18-90, higher scores=worse grief | higher scores=higher grief | Posted | Mean | Standard Deviation | units on a scale | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) |
|
|
|
| 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. | higher scores=greater guilt | Posted | Mean | Standard Deviation | units on a scale | Pre-intervention (at Week 1) and Post-Intervention (at Week 8) |
|
|
|
| Secondary | Experience Survey | Caregiver assessment of program | Count of items | Posted | Number | participants | Post-Intervention (at Week 8) |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Pre-Intervention (at Week 1) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Post-Intervention (at Week 8) |
|
|
|
| Secondary | Contact Survey | A 9-item measure to assess whether caregivers contacted other caregivers or not. | Posted | Count of Participants | Participants | Post-Intervention (at Week 8) |
|
|
|
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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| D009422 | Nervous System Diseases |
| D057177 | TDP-43 Proteinopathies |
| D019636 | Neurodegenerative Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
|
| Neglecting others post |
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| self care efficacy pre |
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| Self care efficacy post |
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| failing to meet challenges pre |
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| Failing post |
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| Doing wrong by care recipient pre |
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| Doing wrong post |
|