Skip to main content
OpenTrials
Completed

NCT Number: NCT05338710

Support Via Technology: Living and Learning With Advancing 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Science University, Layton Aging and Alzheimer's Disease Center

Portland, Oregon, 97239, United States

About this study

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

  • Gather FTD care partner feedback on STELLA and suggestions for tailoring STELLA for FTD
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

STELLA-FTD

Other

Behavioral intervention for caregivers for those with FTD

Primary outcomes

  1. Revised Memory and Behavior Problems Checklist (RMBPC)

    Time frame: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)

    The primary outcome variable, reactivity, will be assessed with the RMBPC, which measures the frequency of care recipient behavioral symptoms and care partner reactions to these behaviors. The RMBPC was chosen because it aligns with our theoretical foundation that assumes burden is a result of care partner reactions to behavioral symptoms.

    The RMBPC is a 29-item caregiver report measure, 5-point Likert scale with frequency measuring from 0 (never occurred) to 4 (daily or more often) and reactivity measuring from 0 (not at all) to 4 (extremely) for a total score between 0-116 for each subscale (frequency subscale and reactivity subscale). Higher scores indicate greater behavioral problems.

Secondary outcomes

  1. Quality of Life Alzheimer's Disease, Care Partner

    Time frame: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)

    This is a brief, 13-item measure designed specifically to obtain a rating of the caregiver's Quality of Life. The measure focuses on quality of life domains. It uses simple and straightforward language and responses & includes assessments of the individual's relationships with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality. The total range is 13 to 52 with lower scores indicating worse quality of life.

  2. Family Caregiver Self-Efficacy Scale

    Time frame: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)

    Measures caregiver self-efficacy for symptoms management and community support service use. Scale 10-100, higher scores indicating better sense of self-efficacy.

  3. Center for Epidemiologic Studies Depression

    Time frame: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)

    This is a 10-item scale that measures depression; the range is 0 (no depression) to 30 (severe depression).

  4. Marwit Meuser Caregiver Grief Index

    Time frame: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)

    Caregiver grief; Scale 18-90, higher scores=worse grief

  5. Caregiver Guilt Questionnaire (CGQ)

    Time frame: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)

    The CGQ is a 22-item caregiver report measure, 5-point Likert scale designed to measure guilt in caregivers with response options from 0 (never) to 4 (always or almost always). Items are organized into five main subscales that are scored by computing the sum of the scores of the items belonging to the corresponding scale.

    "Guilt about doing wrong by the care recipient" includes 7 items with a score range of 0-28. "Guilt about failing to meet the challenges of caregiving" includes 6 items with item #6 being reverse scored. The score ranges from 0-24. "Guilt about self-care" includes 4 items with a score range of 0-16. "Guilt about neglecting other relatives" includes 2 items with a score range of 0-8. "Guilt about having negative feelings towards other people" includes 3 items with a score range of 0-12.

    The total score on the CGQ consists of the sum of the scores of all the subscales, with a total score ranging from 0-88. A higher total score reflects greater guilt.

  6. Experience Survey

    Time frame: Post-Intervention (at Week 8)

    Caregiver assessment of program

  7. Ten-Item Personality Inventory (TIPI)

    Time frame: Pre-Intervention (at Week 1)

    The Ten-Item Personality Inventory (TIPI) is a 10-item self-report measure of five personality domains: Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness to Experiences. Each item is rated on a 7-point Likert scale ranging from 1 ("Disagree strongly") to 7 ("Agree strongly"). Items 2, 4, 6, 8, and 10 are reverse-scored.

    For this study, items were summed to create a total personality score. Possible total scores range from 10 to 70, with higher scores indicating stronger endorsement of personality characteristics across the five domains (i.e., higher trait expression).

  8. Sleep Hygiene Index

    Time frame: Post-Intervention (at Week 8)

    The Sleep Hygiene Index (SHI) is a self-administered questionnaire used to assess an individual's sleep hygiene practices. It's a tool used in research and clinical settings to evaluate sleep habits and identify potential areas for improvement. Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (always). Total scores range from 0 to 52, with a higher score representing poorer sleep hygiene.

  9. Contact Survey

    Time frame: Post-Intervention (at Week 8)

    A 9-item measure to assess whether caregivers contacted other caregivers or not.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • The Association for Frontotemporal Degeneration

Registry information

Acronym: STELLA-FTD

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2022
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.