Caregiver Burden, Corticobasal Syndrome, Frontotemporal Dementia, Primary Progressive Aphasia (PPA)
Conditions
Keywords
behavioral intervention, FTD
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALSTELLA-FTD Control
Participants receive information about FTD and support via weekly group video-conference-based meetings.
BEHAVIORALSTELLA-FTD Test
The test group receives a information and support, but with a focus that is different from the Control Group
Sponsors
National Institute on Aging (NIA)
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
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.
Intervention model description
STELLA-FTD is a 36-week randomized controlled, repeated measures study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
Family Care Partner * Adult caring for family member with FTD. * Provides 4 or more hours of care/week. Does not have to reside with. * Identifies at least 2 moderately upsetting behaviors in the person with FTD. * Speaks and understands English to be able to participate in intervention. * Owns a telephone (smartphone, cell phone or landline). * Has email and mailing address to receive computer, study materials and surveys. * Provides informed consent to participate in the research. * Lives in the US Inclusion Criteria: Person with FTD * Diagnosis of FTD * Family member of a Care Partner (this can be a relative, spouse, or close kin that is considered family). * Lives in US
Exclusion criteria
Person with FTD * No Frontotemporal Degeneration diagnosis. * Unable to leave Care Partner during STELLA-FTD sessions. * Enrolled in hospice.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revised Memory and Behavior Problems Checklist, Frequency, Original Scale | 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention | 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 |
| Revised Memory and Behavior Problems Checklist, Reactivity, Original Scale | 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychiatric Inventory-Caregiver Self-efficacy Scale | 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention | 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). |
| Preparedness for Caregiving Scale | 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention | 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). |
| Personalized Target Behavior Survey | 1 week pre-intervention, 8 week post intervention | 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. |
| Service and Support use survey | 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention | 10-item survey that queries participants about service use. Score is not on a scale. |
| Support via Telehealth: Living and Learning with Advancing Frontotemporal Dementia Experience Survey | 1 week post intervention | 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 |
| Revised Memory and Behavior Problem Checklist Frontotemporal Degeneration Supplement, Reactivity | 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention | Measures caregivers reactions to upsetting frontotemporal behaviors. 9 items, scores range from 0 (no reactivity) to 36 (high reactivity) |
| Revised Memory and Behavior Problem Checklist Frontotemporal Degeneration Supplement, Frequency | 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention | Measures frequency of upsetting frontotemporal behaviors. 9 items, scores range from 0 (no behaviors) to 36 (all behaviors) |
| Clinical Dementia Rating Scale plus Frontotemporal Lobar Degeneration | One time assessment at enrollment | 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) |
| Ten Item Personality Inventory | Once, at Week 1 of intervention | 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. |
| Contact Survey | Week 13, 20, and 36 | Nine questions query caregivers about if they contacted other caregivers in the study, and, if so, how often. Score is not on a scale |
| Orbit Survey | Weekly, starts at Week 1, ends after week 36. | Weekly survey of burden, service use, medication use. Score is not on a scale. |
| Self-efficacy for symptom management and support service use | 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention | 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. |
Countries
United States
Contacts
Primary ContactHailey Chatterton, MS
Backup ContactAllison Lindauer, PhD, APRN
Outcome results
None listed