18 and older, any sex, with Dementia or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Revised Memory and Behavior Problems Checklist, Reactivity SubscalePrimary· 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 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
Pre-Intervention (Nova)
Group
Value
95% CI
Care Partners
40.7
± 15.3
Post-Intervention (Nova)
Group
Value
95% CI
Care Partners
35.6
± 16.5
One Month Follow-Up (Nova)
Group
Value
95% CI
Care Partners
35.7
± 16.4
Pre-Intervention (Constellation)
Group
Value
95% CI
Care Partners
35.0
± 16.6
Post-Intervention (Constellation)
Group
Value
95% CI
Care Partners
33.2
± 16.4
Two Month Follow-Up (Constellation)
Group
Value
95% CI
Care Partners
33.0
± 16.3
Overall
Group
Value
95% CI
Care Partners
36.1
± 16.4
Marwit Meuser Caregiver Grief Index-Short FormSecondary· 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.
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.
Pre-Intervention (Nova)
Group
Value
95% CI
Care Partners
57.8
± 12.4
Post-Intervention (Nova)
Group
Value
95% CI
Care Partners
57.4
± 13.0
One Month Follow-Up (Nova)
Group
Value
95% CI
Care Partners
57.4
± 12.8
Pre-Intervention (Constellation)
Group
Value
95% CI
Care Partners
55.8
± 12.3
Post-Intervention (Constellation)
Group
Value
95% CI
Care Partners
56.2
± 12.4
Two-Month Follow-Up (Constellation)
Group
Value
95% CI
Care Partners
55.3
± 12.0
Overall
Group
Value
95% CI
Care Partners
56.8
± 12.5
Quality of Life-Alzheimer's Disease (QoL-AD), Care PartnerSecondary· 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 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.
Pre-Intervention (Nova)
Group
Value
95% CI
Care Partners
34.7
± 6.07
Post-Intervention (Nova)
Group
Value
95% CI
Care Partners
35.1
± 6.09
One Month Follow-Up (Nova)
Group
Value
95% CI
Care Partners
34.9
± 6.25
Pre-Intervention (Constellation)
Group
Value
95% CI
Care Partners
35.0
± 6.38
Post-Intervention (Constellation)
Group
Value
95% CI
Care Partners
35.7
± 6.16
Two Month Follow-Up (Constellation)
Group
Value
95% CI
Care Partners
35.6
± 5.66
Overall
Group
Value
95% CI
Care Partners
35.1
± 6.11
Center for Epidemiologic Studies Depression Scale, 10-item (CES-D 10)Secondary· 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 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.
Pre-Intervention (Nova)
Group
Value
95% CI
Care Partners
11.9
± 6.16
Post-Intervention (Nova)
Group
Value
95% CI
Care Partners
10.9
± 6.07
One Month Follow-Up (Nova)
Group
Value
95% CI
Care Partners
11.3
± 6.13
Pre-Intervention (Constellation)
Group
Value
95% CI
Care Partners
11.1
± 6.27
Post-Intervention (Constellation)
Group
Value
95% CI
Care Partners
10.6
± 6.37
Two Month Follow-Up (Constellation)
Group
Value
95% CI
Care Partners
10.2
± 6.09
Overall
Group
Value
95% CI
Care Partners
11.1
± 6.18
4-item Zarit Burden Interview (ZBI-4)Secondary· Baseline (first weekly survey at study enrollment, prior to intervention).
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.
Group
Value
95% CI
Care Partners
9.41
± 2.83
Ten Item Personality Inventory (TIPI)Secondary· Baseline (1 week prior to Constellation intervention start)
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.
Extraverted, enthusiastic
Group
Value
95% CI
Care Partners
4.50
± 1.89
Critical, quarrelsome
Group
Value
95% CI
Care Partners
5.30
± 1.54
Dependable, self-disciplined
Group
Value
95% CI
Care Partners
6.12
± 1.04
Anxious, easily upset
Group
Value
95% CI
Care Partners
4.43
± 1.86
Openness to new experiences, complex
Group
Value
95% CI
Care Partners
5.78
± 1.08
Reserved, quiet
Group
Value
95% CI
Care Partners
4.03
± 1.84
Sympathetic, warm
Group
Value
95% CI
Care Partners
5.94
± 1.15
Disorganized, careless
Group
Value
95% CI
Care Partners
5.36
± 1.70
Computer Self-Efficacy and Computer Anxiety SurveySecondary· Baseline (at study enrollment) and post-Constellation (8 weeks after Constellation start)
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.
Strongly disagree (pre-intervention)
Group
Value
95% CI
Care Partners
0
Strongly disagree (post-intervention)
Group
Value
95% CI
Care Partners
3
Disagree (pre-intervention)
Group
Value
95% CI
Care Partners
6
Disagree (post-intervention)
Group
Value
95% CI
Care Partners
4
Neutral (pre-intervention)
Group
Value
95% CI
Care Partners
36
Neutral (post-intervention)
Group
Value
95% CI
Care Partners
6
Agree (pre-intervention)
Group
Value
95% CI
Care Partners
71
Agree (post-intervention)
Group
Value
95% CI
Care Partners
22
Quality of Life-Alzheimer's Disease (QoL-AD), Care RecipientSecondary· 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 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.
Pre-Intervention (Nova)
Group
Value
95% CI
Care Partners
29.9
± 7.01
Post-Intervention (Nova)
Group
Value
95% CI
Care Partners
29.8
± 7.17
One Month Follow-Up (Nova)
Group
Value
95% CI
Care Partners
29.6
± 7.24
Pre-Intervention (Constellation)
Group
Value
95% CI
Care Partners
30.1
± 7.56
Post-Intervention (Constellation)
Group
Value
95% CI
Care Partners
30.7
± 7.32
Two Month Follow-Up (Constellation)
Group
Value
95% CI
Care Partners
29.9
± 7.45
Overall
Group
Value
95% CI
Care Partners
30.0
± 7.25
Revised Memory and Behavior Problems Checklist, Frequency SubscalePrimary· 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 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
Pre-Intervention (Nova)
Group
Value
95% CI
Care Partners
43.7
± 13.6
Post-Intervention (Nova)
Group
Value
95% CI
Care Partners
39.9
± 12.0
One Month Follow-Up (Nova)
Group
Value
95% CI
Care Partners
39.7
± 12.9
Pre-Intervention (Constellation)
Group
Value
95% CI
Care Partners
39.2
± 13.8
Post-Intervention (Constellation)
Group
Value
95% CI
Care Partners
40.2
± 14.7
Two Month Follow-Up (Constellation)
Group
Value
95% CI
Care Partners
40.3
± 12.1
Overall
Group
Value
95% CI
Care Partners
40.7
± 13.2
Adverse events — posted to ClinicalTrials.gov
Time frame: Care Partners and Care Recipients could be in the study for over 1 year depending on the Care Partner's availability to join the interventions. Care Partners would report on adverse events for themselves and their care recipients from the time they consented to participate through study completion. Care Recipients did not participate in the intervention, but adverse events and serious adverse events were collected..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oregon Health and Science University
Last refreshed: 20 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04627662.