STELLA-FTD: Examination of a Behavior Change Intervention for FTD Family Care Partners
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 640
- 试验地点
- 2
- 主要终点
- Revised Memory and Behavior Problems Checklist, Frequency, Original Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Person with FTD
- •No Frontotemporal Degeneration diagnosis.
- •Unable to leave Care Partner during STELLA-FTD sessions.
- •Enrolled in hospice.
- •Exclusion Criteria: Family Care Partner
- •Unable to find activity for Care Recipient during STELLA-FTD sessions to allow Care Partner to work privately with Guide and other Care Partners.
- •Hearing and/or vision problems severe enough to prevent participation.
- •Refuses to be video-recorded during STELLA-FTD sessions.
- •Unwilling or unable to adequately follow study instructions and participate in study procedures.
结局指标
主要结局
Revised Memory and Behavior Problems Checklist, Frequency, Original Scale
时间窗: 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
时间窗: 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
次要结局
- 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)
- Neuropsychiatric Inventory-Caregiver Self-efficacy Scale(1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention)
- Preparedness for Caregiving Scale(1 month pre-intervention; 1 week pre-intervention, 8 week post intervention; 2 and 6 months post intervention)
- Personalized Target Behavior Survey(1 week pre-intervention, 8 week post intervention)
- Service and Support use survey(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(1 week post intervention)
- Orbit Survey(Weekly, starts at Week 1, ends after week 36.)
- 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)
- 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)
- Clinical Dementia Rating Scale plus Frontotemporal Lobar Degeneration(One time assessment at enrollment)
- Ten Item Personality Inventory(Once, at Week 1 of intervention)
- Contact Survey(Week 13, 20, and 36)
研究者
Allison Lindauer
Associate Professor
Oregon Health and Science University