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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG084523 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this nationwide study is to test STELLA-FTD (Support via Telehealth: Living and Learning with Advancing Alzheimer's Disease)-FTD, an intervention to specifically address the needs of family Care Partners of persons with frontotemporal degeneration (FTD). STELLA-FTD is a multicomponent videoconference-based intervention designed to facilitate effective use of community and peer resources to foster effective management of behavioral and psychological symptoms of dementia. The study is recruiting families from across the United States.
The study will enroll a total sample of up to 640 participants: 320 family Care Partners and their 320 Care Recipients with FTD. For our study "family Care Partner" includes any person who is considered "family" to the person with FTD, such as direct relations, fictive kin, close friends and neighbors. "Care Recipient" is defined as an individual with an FTD diagnosis noted by the AFTD: bv-FTD, PPA, progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), or ALS with FTD. Care Recipients with FTD will not participate in intervention but will be consented (and thus enrolled) because data will be collected about them. The study will test to see if our program helps Care Partners.
The STELLA-FTD intervention is delivered over 8 sessions within 10 consecutive weeks in 1-hour "live" video-based group sessions led by two guides. There will be two intervention groups, the control group and the test group. There will be up to 8 Care Partners per group, which allows for the development of mutual trust and commitment.
Care Partners will be randomized to either the test or control group using an electronic randomization process and will be blinded to their group designation. Both groups will receive information and support (via videoconferencing). The test group will receive a different program than the control group. Care Partners will fill out 6 long surveys while in the study, and a brief weekly survey.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Control group, receives information and support in a group setting (N=160 Care Partners). |
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| Test Group | Experimental | Test group, receives information and support in a group setting, but program is different from control (N=160 Care Partners). |
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| Care Recipients with FTD | No Intervention | Care recipients are consented to inform them of their rights, but they do not take part in any activities (N=320 Care Recipients). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STELLA-FTD Control | Behavioral | Participants receive information about FTD and support via weekly group video-conference-based meetings. |
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| Measure | Description | Time Frame |
|---|---|---|
| Revised Memory and Behavior Problems Checklist, Frequency, Original Scale | Efficacy will be assessed by measuring pre/post changes on the RMBPC. The RMBPC is a 24-item caregiver report measure, 5-point Likert scale with higher scores on frequency indicate more upsetting behaviors Frequency range is 0 (never occurred) to 4 (daily or more often). Frequency score range is 0 to 96 | 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention |
| Revised Memory and Behavior Problems Checklist, Reactivity, Original Scale | Efficacy will be assessed by measuring pre/post changes on the RMBPC. The RMBPC is a 24-item caregiver report measure, 5-point Likert scale with higher scores on reactivity indicate more Care Partner burden. Frequency range is 0 (no burden) to 4 (high burden). Frequency score range is 0 to 96 | 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Self-efficacy for symptom management and support service use | 10-item scale to measure self-efficacy. Assesses caregiver certainty that they will use services and support programing. 1= not at all certain, to 10=very certain. Scores range from 10 to 100, with 100 being high certainty. | 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention |
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Inclusion Criteria: Family Care Partner
Inclusion Criteria: Person with FTD
Exclusion Criteria: Person with FTD
Exclusion Criteria: Family Care Partner
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hailey Chatterton, MS | Contact | 503-568-9725 | chatterton@ohsu.edu | |
| Allison Lindauer, PhD, APRN | Contact | 503-494-6976 | lindauer@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Allison Lindauer, PhD, APRN | Oregon Health and Science University | Principal Investigator |
| Aimee Mooney, MA, CCC-SLP | Oregon Health and Science University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37655616 | Background | 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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| ID | Type | URL | Comment |
|---|---|---|---|
| data set | View IPD |
Aggregated data for journal articles and presentations, IPD via data request to OHSU
2/15/2025-7/14/2029
Scientists can contact our center to request data
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| ID | Term |
|---|---|
| D057180 | Frontotemporal Dementia |
| D000084802 | Caregiver Burden |
| D018888 | Aphasia, Primary Progressive |
| D000088282 | Corticobasal Degeneration |
| ID | Term |
|---|---|
| D057174 | Frontotemporal Lobar Degeneration |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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STELLA-FTD is a 36-week randomized controlled, repeated measures study.
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Care Partners will be randomized to either the test or control group using an electronic randomization process and will be blinded to their group designation. Interventionists will also be blinded to their group designation (test or control) and the differences between the two programs.
| STELLA-FTD Test | Behavioral | The test group receives a information and support, but with a focus that is different from the Control Group |
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| Neuropsychiatric Inventory-Caregiver Self-efficacy Scale | Measures frequency of behaviors related to frontotemporal dementia and Care Partner confidence in managing behaviors. Frequency is rated on a scale of 1 (occasionally) to 4 (very frequently), severity is rated from 1 (mild) to 3 (severe), and caregiver distress is rated from 0 (no distress) to 5 (extreme or very severe). Total scores are calculated by multiplication of the frequency and severity for each symptom and the addition of all item scores, with a range of 0-144. The distress score total is calculated by the sum of all the individual domain scores, with a range of between 0 and 60. If a behavioral symptom is noted, the care partner is asked to about how confident they are in addressing it, Responses range from 4 (not at all confident), 3 (fairly confident), 2 (confident), and 1 (very confident). | 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention |
| Preparedness for Caregiving Scale | 10-item measure that assesses how prepared care partners feel to care for their family member with dementia. Ranges from 0 (not at all prepared) to 40 (very well prepared). | 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention |
| Personalized Target Behavior Survey | On STELLA-FTD Website, measures frequency and reactivity of up to 3 personalized behaviors identified by Care Partners. Care partners rate how often the 5-point Likert scale with higher scores on frequency indicate more upsetting behaviors Frequency range is 0 (never occurred) to 4 (daily or more often). Frequency score range is 0 to 4 for each Target behavior. Higher scores indicate higher frequency and burden. | 1 week pre-intervention, 8 week post intervention |
| Service and Support use survey | 10-item survey that queries participants about service use. Score is not on a scale. | 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention |
| Support via Telehealth: Living and Learning with Advancing Frontotemporal Dementia Experience Survey | 18-item- survey on satisfaction, privacy, ease of use. Scores range from 1 (strongly disagree) to 5 (strongly agree). Total score ranged 18-90, higher scores are better | 1 week post intervention |
| Orbit Survey | Weekly survey of burden, service use, medication use. Score is not on a scale. | Weekly, starts at Week 1, ends after week 36. |
| Revised Memory and Behavior Problem Checklist Frontotemporal Degeneration Supplement, Frequency | Measures frequency of upsetting frontotemporal behaviors. 9 items, scores range from 0 (no behaviors) to 36 (all behaviors) | 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention |
| Revised Memory and Behavior Problem Checklist Frontotemporal Degeneration Supplement, Reactivity | Measures caregivers reactions to upsetting frontotemporal behaviors. 9 items, scores range from 0 (no reactivity) to 36 (high reactivity) | 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention |
| Clinical Dementia Rating Scale plus Frontotemporal Lobar Degeneration | This is an 8-item survey that assesses disease severity, with 0=no impairment to 3=severe impairment. Range is 0-24 (Sum of boxes) | One time assessment at enrollment |
| Ten Item Personality Inventory | 10 items that assess personality type. Respondents note how they agree with each. personality type, from 1=Disagree strongly 2 = Disagree moderately 3 = Disagree a little 4 = Neither agree nor disagree 5 = Agree a little 6 = Agree moderately 7 = Agree strongly Score is not on a scale. | Once, at Week 1 of intervention |
| Contact Survey | Nine questions query caregivers about if they contacted other caregivers in the study, and, if so, how often. Score is not on a scale | Week 13, 20, and 36 |
| 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 |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001037 | Aphasia |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D024801 | Tauopathies |