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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
640
Participants receive information about FTD and support via weekly group video-conference-based meetings.
The test group receives a information and support, but with a focus that is different from the Control Group
Oregon Health & Science University
Portland, Oregon, United States
RECRUITINGRevised 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
Time frame: 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
Time frame: 1 month pre-intervention; 1 week pre-intervention, 4 weeks after intervention start; 8 week post intervention; 2 and 6 months post intervention
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.
Time frame: 1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 1 week post intervention
Orbit Survey
Weekly survey of burden, service use, medication use. Score is not on a scale.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: Week 13, 20, and 36
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