Support Via Technology: Living and Learning With Advancing FTD (STELLA-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 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.

Study Overview

• Status: Completed
• Conditions: Frontotemporal Dementia; Caregivers Burnout
• Intervention / Treatment: Other: STELLA-FTD

Detailed Description

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

1. Gather FTD care partner feedback on STELLA and suggestions for tailoring STELLA for FTD
2. Adapt STELLA for FTD care partners based on end-user feedback Aim 2. Assess the feasibility, acceptability and STELLA-FTD with FTD care partners Aim 3. Assess the preliminary efficacy of STELLA-FTD on the primary outcomes: reducing the frequency of behavioral symptoms and care partner reactivity to the symptoms as measured on the Revised Memory and Behavior Problems Checklist (RMBPC).

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Care Partner for family member, close friend or kin with FTD, primary progressive aphasia, progressive supranuclear palsy or other frontotemporal degenerative dementia
• Must speak English
• Must be able to see and hear the videoconference-based interactions.

Exclusion Criteria:

- Family member does not care for someone with FTD conditions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revised Memory and Behavior Problems Checklist (change is being assessed) Behavior Problems Checklist	Assesses burden, stress: Higher scores on frequency indicate more upsetting behaviors, higher scores on reactivity indicate more caregiver burden	Weeks 1 and 9 of study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life, care partners and care recipients (change is being assessed)	Measures sense of quality of life for Care Partner; 13 items, higher scores suggest better quality of life	Weeks 1 and 9 of study
Quality of life, care partners and care recipients (change is being assessed)	Measures sense of quality of life for person with dementia (filled out by proxy caregiver): 13 items, higher scores suggest better quality of life	Weeks 1 and 9 of study
Family Caregiver Self efficacy scale (change is being assessed)	measures caregiver self efficacy for symptoms management and community support service use. Scale 10-100, higher scores indicating better sense of self-efficacy	Weeks 1 and 9 of study
Center for Epidemiologic Studies Depression-10-item scale (change is being assessed); score is 0 (no depression) to 30 (severe depression).	Depression in caregivers	Weeks 1 and 9 of study
Marwit Meuser Caregiver Grief Index (change is being assessed)	Caregiver grief; Scale 18-90, higher scores=worse grief	Weeks 1 and 9 of study
Caregiver Guilt Questionnaire (change is being assessed)	Caregiver guilt; score range 22-88, higher scores=worse guilt	Weeks 1 and 9 of study
Contact survey	How often do caregivers contact each other?	9 weeks after study start
Experience Survey	Caregiver assessment of program	9 weeks after study start
Ten-item personality inventory	Measures extra/introversion (provides information about introversion/extraversion, no "good" or "bad" scores	Week 1 of study

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Association for Frontotemporal Degeneration

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Actual): March 4, 2022
• Study Completion (Actual): March 4, 2022

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Stress, Psychological; TDP-43 Proteinopathies; Proteostasis Deficiencies; Dementia; Language Disorders; Communication Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Caregiver Burden
• Other Study ID Numbers: 22721

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No