AzTrials
AzTrials

Caregivers BurnoutSTELLA-FTDNCT05338710

Support Via Technology: Living and Learning With Advancing FTD

A study testing STELLA-FTD in people with Caregivers Burnout and Frontotemporal Dementia, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Caregivers Burnout, Frontotemporal Dementia
What is being tested?
STELLA-FTD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
14 Jan 2021to 4 Mar 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Portland, Oregon, 97239

Other trials in 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 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.

Read the 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).
Being tested
STELLA-FTD
Medical subject headings
Frontotemporal Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STELLA-FTDOther

    Behavioral intervention for caregivers for those with FTD

Study groups in NCT05338710
Study groupRoleWhat they receive
STELLA-FTD studyExperimentalOne group only
Receives: Other: STELLA-FTD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Revised Memory and Behavior Problems Checklist (RMBPC)

    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.

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

Secondary outcomes (9)

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

    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.

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

  2. Family Caregiver Self-Efficacy Scale

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

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

  3. Center for Epidemiologic Studies Depression

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

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

  4. Marwit Meuser Caregiver Grief Index

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

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

  5. Caregiver Guilt Questionnaire (CGQ)

    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.

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

  6. Experience Survey

    Caregiver assessment of program

    Measured: Post-Intervention (at Week 8)

  7. Ten-Item Personality Inventory (TIPI)

    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).

    Measured: Pre-Intervention (at Week 1)

  8. Sleep Hygiene Index

    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.

    Measured: Post-Intervention (at Week 8)

  9. Contact Survey

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

    Measured: Post-Intervention (at Week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2022
  2. Study start14 Jan 2021
  3. Primary completion4 Mar 2022
  4. Study completion4 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
8-week single group intervention
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05338710
Sponsor's protocol ID
STUDY00022721
Acronym
STELLA-FTD
Status last verified
Nov 2025
First submitted
4 Mar 2022
Last updated
25 Nov 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Lindauer A, Smith S, Gothard S, Mattek N, Tran L, Mooney A. 'There's no straight line...' a consumer-informed intervention for FTD family care partners: the STELLA-FTD pilot study. Aging Ment Health. 2023 Sep-Oct;27(10):2000-2010. doi: 10.1080/13607863.2023.2250741. Epub 2023 Sep 1.

    PubMed 37655616

Questions about this trial

What is this clinical trial studying?

A study testing STELLA-FTD in people with Caregivers Burnout and Frontotemporal Dementia, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Revised Memory and Behavior Problems Checklist (RMBPC) (time frame: Pre-intervention (at Week 1) and Post-Intervention (at Week 8)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05338710, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in