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DementiaTele-STELLANCT04627662

Using Technology to Support Care Partners for Persons With Alzheimer's Disease: Tele-STELLA

A study testing Tele-STELLA in people with Dementia and Alzheimer Disease, 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
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Trial summary

The purpose of this study is to test a revised psychoeducational intervention to help Care Partners for family members with dementia understand and reduce the distressing behaviors that come with progressive dementia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dementia, Alzheimer Disease, Caregiver Burnout
What is being tested?
Tele-STELLA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
375 participants
Where
1 siteUnited States
Study dates
14 May 2021to 9 Jul 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Care Recipient Inclusion Criteria:

  • Diagnosis of ADRD, moderate to late stages as defined by family member (Box 1)
  • Exhibits 2 or more behaviors listed on RMBPC that are bothersome to the Care Partner and occur 3 or more times/week at study enrollment
  • Family member of Care Partner (this can be a relative, spouse or close kin that is considered family)

Care Recipient Exclusion Criteria:

  • Dementia not related to ADRD
  • Unable to leave Care Partner during Tele-STELLA sessions
  • Early stage dementia, as defined by family member

Care Partner Inclusion Criteria:

  • Adult caring for family member with ADRD
  • Provides care for at least 4 hours/week
  • Age of 18 years or older
  • Speaks and understands English to be able to participate in intervention
  • Owns a telephone (smartphone, cell phone or landline)
  • Has mailing address to receive computer and study materials
  • Provides informed consent to participate in the Research

Care Partner Exclusion Criteria:

  • Unable to find activity for care recipient during Tele-STELLA sessions to allow Care Partner to work privately with Guide and other Care Partners.
  • Completed similar telehealth intervention within the last year
  • Hearing and/or vision problems severe enough to prevent participation
  • Unwilling or unable to adequately follow study instructions and participate in study procedures

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

The purpose of this study is to test a revised psychoeducational intervention to help Care Partners for family members with dementia understand and reduce the distressing behaviors that come with progressive dementia. Tele-STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer's disease and related dementias) is a multicomponent videoconference-based intervention designed to facilitate effective management of behavioral and psychological symptoms common to the later stages of dementia. In the Tele-STELLA intervention, professionals ("Guides") meet with family members ("Care Partners") who care for persons with dementia. Working together, the Care Partners and Guides identify strategies to address upsetting behaviors. The goal of this intervention is to reduce upsetting behaviors and, thus, Care Partner burden.

Read the detailed description

Providing care for a family member with Alzheimer's disease and related dementias (ADRD, aka, "dementia") is both rewarding and risky. Care Partners exposed to chronic stress, often over years, are susceptible to physical and psychological ailments. Effective interventions that reduce Care Partner burden and health risks are available, but various factors impede participation, including distance, cost, behavioral symptoms of dementia, stigma and social anxiety. Recognizing the need to reduce barriers to access, scientists have turned to Internet-based interventions. Recent research indicates that multi-component, technology-facilitated interventions which allow Care Partner engagement with health professionals are effective and favored by Care Partners. However, a minority of telehealth-based interventions allow for health professional engagement and, of these, only a handful provide real-time interaction. Further, Hopwood et al. concluded that, despite the fact that family needs vary across ADRD stages, the interventions reviewed were not targeted to specific stages of dementia.

To address the needs of families living with dementia, the investigators have completed two pilot studies using Internet-based Care Partner interventions. These studies tested the feasibility and consumer acceptability of the evidence-based, STAR-C intervention, the precursor to Tele-STELLA, when delivered via telehealth. Qualitative data revealed the telehealth intervention was acceptable to Care Partners and preferred over a potential in-home intervention. The investigators found that burden was reduced, but depression was not. This may be because the interaction with the Guide formally ended after Session 8, leaving Care Partners with a sense of isolation, as this one commented: "I went through withdrawals… I wanted to call her (the Guide)-who can I turn to?" The prototype interventions did not include meaningful opportunities for Care Partners to interact with each other post-intervention. Care Partners felt their support vanished and did not like "the fact that it was over." Care Partners advised that future interventions should include both one-to-one sessions and one-to-multiple sessions.

Based on the qualitative and quantitative data from the pilot work, Tele-STELLA was designed to address the specific needs of families living with moderate to severe dementia. Tele-STELLA is a multi-component, tailored intervention that begins with one-to-one sessions with each Care Partner and Guide, then links Care Partners to each other in a meaningful way to sustain support post intervention. Tele-STELLA is designed for families living in the later stages of dementia, where behavioral symptoms are more prominent and distressing.

The ultimate goal of this study is to diminish the frequency of behavioral symptoms that persons with dementia experience, and Care Partner reactivity to these symptoms. Based on Kales et al. framework, behavioral symptoms arise from unmet needs, overburdened Care Partners and environmental factors, all within the context of cultural background and beliefs. Behavioral symptoms are bidirectional in that the person with dementia's behaviors affects the Care Partner's behaviors and vice versa. The investigators hypothesize that addressing these factors will reduce behavioral symptom frequency, and, in turn, Care Partner reactivity to them, resulting in reduced Care Partner burden, depression and grief.

Tele-STELLA allows all study activities to be done in Care Partners' homes, using videoconferencing, email and phones. This includes assessments of burden and depression using electronic versions of classic measures. No visits to university sites are needed.

The purpose of this study is to test a revised psychoeducational intervention to help Care Partners for family members with dementia understand and reduce the distressing behaviors that come with progressive dementia. Tele-STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer's disease and related dementias) is a multicomponent videoconference-based intervention designed to facilitate effective management of behavioral and psychological symptoms common to the later stages of dementia. In the Tele-STELLA intervention, professionals ("Guides") meet with family members ("Care Partners") who care for persons with dementia. Working together, the Care Partners and Guides identify strategies to address upsetting behaviors. The goal of this intervention is to reduce upsetting behaviors and, thus, Care Partner burden.

The specific aims of this study are:

Aim 1. Establish the feasibility and acceptability of Tele-STELLA

  1. Assess the feasibility of implementing Tele-STELLA with a national participant pool, including participants from multiple Alzheimer's Disease Research Centers.
  2. Assess feasibility and acceptability of the Constellation component of Tele-STELLA.
  3. Assess user acceptability of Tele-STELLA and fidelity to the intervention protocol. Refine and optimize Tele-STELLA, as needed, based on above findings.

Aim 2. Establish the efficacy of Tele-STELLA in reducing the frequency of behavioral and psychological symptoms of dementia (BPSD) and Care Partner reactivity to the symptoms.

H1: Participants who completed the Tele-STELLA intervention will report a significant reduction in the frequency of BPSD and Care Partner reactivity to the BPSD.

Being tested
Tele-STELLA
Medical subject headings
Dementia, Alzheimer Disease, Caregiver Burden

What participants receive

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

  • Tele-STELLABehavioural

    Tele-STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer's disease and related dementias) is a multicomponent videoconference-based intervention designed to facilitate effective management of behavioral and psychological symptoms common to the later stages of dementia.

Study groups in NCT04627662
Study groupRoleWhat they receive
Care PartnersOtherBased on previous work, we will recruit up to 75 Care Partners and their 75 care recipients with dementia. This allows for 20% attrition. We will recruit participants from Alzheimer's Disease Research Centers (ADRCs) and other national locations.
Receives: Behavioral: Tele-STELLA

What is being measured

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

  1. Revised Memory and Behavior Problems Checklist, Reactivity Subscale

    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: Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

  2. Revised Memory and Behavior Problems Checklist, Frequency Subscale

    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: Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

Secondary outcomes (7)
  1. Marwit Meuser Caregiver Grief Index-Short Form

    Marwit-Meuser Caregiver Grief Index-Short Form (MM-CGI) is an 18-item caregiver-report measure of pre-death grief. Items are on a 5-point Likert scale and summed for a total score ranging between 18 to 90. Higher scores on this measure indicate greater caregiver grief.

    Measured: Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

  2. Quality of Life-Alzheimer's Disease (QoL-AD), Care Partner

    The Quality of Life-Alzheimer's Disease (QoL-AD), Care Partner version includes 13 items on a 4-point Likert scale with answers ranging from 1 = poor to 4 = excellent. The total score is the sum of items with a score range between 13-52. Higher scores indicate a better perceived quality of life for the care partner.

    Measured: Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

  3. Center for Epidemiologic Studies Depression Scale, 10-item (CES-D 10)

    The 10-item Center for Epidemiologic Studies Depression Scale (CES-D 10) is a self-report measure of depressive symptoms on a 4-point Likert scale with answers ranging from 0-3 (0 = rarely/none to 3 = most/all of the time). Items are summed after reverse scoring for the two positively worded items with a total score range of 0-30. Higher scores indicate greater depressive symptoms.

    Measured: Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

  4. 4-item Zarit Burden Interview (ZBI-4)

    Zarit Burden Intervention 4-item (ZBI-4) is a 4-item caregiver-report measure of perceived burden. Items were on a 5-point Likert scale ranging from 0 (never) to 4 (nearly always). The total score was the sum of items with a range of 0-16. Higher scores indicated greater caregiver burden.

    Measured: Baseline (first weekly survey at study enrollment, prior to intervention).

  5. Ten Item Personality Inventory (TIPI)

    The Ten Item Personality Inventory (TIPI) is a 10-item Likert scale measure of the Big Five personality traits. Choices range from 1(disagree strongly) to 7 (agree strongly) with reverse scoring on items 2, 4, 6, 8 and 10. Scoring included the average of the two items as follows: extraversion: 1, 6R; agreeableness: 2R, 7; conscientiousness: 3, 8R; emotional stability: 4R, 9; openness to experiences: 5, 10R. Each trait had a score range of 1-7 with higher scores indicating greater standing on each trait dimension.

    Measured: Baseline (1 week prior to Constellation intervention start)

  6. Computer Self-Efficacy and Computer Anxiety Survey

    Investigator-developed single-item measure of computer self-efficacy: "I am confident in my ability to use computers." Care partners rated this sentence from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater perceived computer self-efficacy.

    Measured: Baseline (at study enrollment) and post-Constellation (8 weeks after Constellation start)

  7. Quality of Life-Alzheimer's Disease (QoL-AD), Care Recipient

    The Quality of Life-Alzheimer's Disease (QoL-AD), Care Recipient version includes 13 items on a 4-point Likert scale with answers ranging from 1 = poor to 4 = excellent. Care partners reported on this based on how they think their care recipient would respond. The total score is the sum of items with a score range between 13-52. Higher scores indicate a better perceived quality of life for the care recipient.

    Measured: Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.

Timeline

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

  1. First posted13 Nov 2020
  2. Study start14 May 2021
  3. Primary completion9 Jul 2025
  4. Study completion9 Jul 2025

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Care partners will participate in 2, 8-week sessions to learn about distressing behavioral symptoms in dementia.
Masking
None (open label)
Enrolment
375 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04627662
Sponsor's protocol ID
STUDY00022288
Acronym
Tele-STELLA
Status last verified
Feb 2026
First submitted
8 Nov 2020
Last updated
20 Mar 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified IPD will be available upon request to our Alzheimer's Disease Research Center

Publications

  • Lindauer A, Messecar D, McKenzie G, Gibson A, Wharton W, Bianchi A, Tarter R, Tadesse R, Boardman C, Golonka O, Gothard S, Dodge HH. The Tele-STELLA protocol: Telehealth-based support for families living with later-stage Alzheimer's disease. J Adv Nurs. 2021 Oct;77(10):4254-4267. doi: 10.1111/jan.14980. Epub 2021 Jul 20.

    PubMed 34288013

Questions about this trial

What is this clinical trial studying?

A study testing Tele-STELLA in people with Dementia and Alzheimer Disease, 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?

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 20 Mar 2026. 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 20 Mar 2026). 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, Reactivity Subscale (time frame: Baseline (1 week pre-Nova); post-Nova (8 weeks); 1-month follow-up (12 weeks). For Constellation: baseline (1 week pre-start); post (8 weeks); 2-month follow-up (16 weeks). Constellation could begin up to 12 months after Nova.). The study lists 2 primary outcomes in all. 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 NCT04627662, 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 20 Mar 2026.

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