Trial Outcomes & Findings for Assessing Acceptability, Cost, and Efficacy of STELLA-Support Via Technology (NCT NCT04335110)
NCT ID: NCT04335110
Last Updated: 2024-01-23
Results Overview
Care recipient frequency of behaviors and caregiver reactions to behavioral symptoms. The scale measures how often a behavior occurs (Frequency, "F") and how much the caregiver reacts to it (Reactivity, "R"). Range for both scales is 0-96, lower scores are better. Subscales are not combined.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
The RMBPC is assessed 1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)
Results posted on
2024-01-23
Participant Flow
Administrative delays and COVID interference caused substantial delays in enrollment. Further enrollment required initial enrollment in the parent study, thus limiting recruitment pool. Recruitment started in Winter 2021, ending in Spring 2022.
Participants were assigned to care partner group (intervention) or care recipient (no intervention). The majority of participants that were referred to STELLA from ORCASTRAIT were eligible for the study.
Participant milestones
| Measure |
Intervention
STELLA participants were be recruited from the existing cohort of patients who were enrolled in the Oregon Roybal Center for CAre Support Translational Research Advantaged by Integrating Technology) ORCASTRAIT Life Laboratory (OSLL).
STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer's disease and related dementias): STELLA consists of 8 sessions: 4 sessions one-to-one, with the Care Partner and a Guide, and then 4 sessions with one Guide with up to four Care Partners (total small group will include as few as two and as many as 4 Care Partners) Each weekly session takes about 1 hour. The first four sessions allow for development of the Care Partner-Guide working relationship. In these sessions, the Care Partners identify behaviors (both the person with dementia's and the Care Partner's) which are upsetting to the family. Care Partners will be taught to use an Activator, Behavior, Consequence (ABC) approach to identify activators of behaviors, the behaviors, and consequences of the behaviors. After they identify the ABCs, they will develop a plan to address the behavior and then test it. After the four one-to-one sessions, Care Partners will meet in small groups with a Guide. Effective communication strategies, engagement in pleasant events, and coping will be addressed.
|
Care Recipient
Care recipients did not receive the intervention
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Intervention
STELLA participants were be recruited from the existing cohort of patients who were enrolled in the Oregon Roybal Center for CAre Support Translational Research Advantaged by Integrating Technology) ORCASTRAIT Life Laboratory (OSLL).
STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer's disease and related dementias): STELLA consists of 8 sessions: 4 sessions one-to-one, with the Care Partner and a Guide, and then 4 sessions with one Guide with up to four Care Partners (total small group will include as few as two and as many as 4 Care Partners) Each weekly session takes about 1 hour. The first four sessions allow for development of the Care Partner-Guide working relationship. In these sessions, the Care Partners identify behaviors (both the person with dementia's and the Care Partner's) which are upsetting to the family. Care Partners will be taught to use an Activator, Behavior, Consequence (ABC) approach to identify activators of behaviors, the behaviors, and consequences of the behaviors. After they identify the ABCs, they will develop a plan to address the behavior and then test it. After the four one-to-one sessions, Care Partners will meet in small groups with a Guide. Effective communication strategies, engagement in pleasant events, and coping will be addressed.
|
Care Recipient
Care recipients did not receive the intervention
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
separate values for care partners and care recipients
Baseline characteristics by cohort
| Measure |
Intervention
n=14 Participants
Care Partners for persons with dementia
|
Care Recipients
n=14 Participants
Care recipients
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=28 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=14 Participants
|
2 Participants
n=14 Participants
|
4 Participants
n=28 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=14 Participants
|
12 Participants
n=14 Participants
|
24 Participants
n=28 Participants
|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 8 • n=13 Participants • separate values for care partners and care recipients
|
76.6 years
STANDARD_DEVIATION 9.8 • n=13 Participants • separate values for care partners and care recipients
|
74.4 years
STANDARD_DEVIATION 9 • n=26 Participants • separate values for care partners and care recipients
|
|
Sex: Female, Male
Female
|
9 Participants
n=14 Participants
|
5 Participants
n=14 Participants
|
14 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=14 Participants
|
9 Participants
n=14 Participants
|
14 Participants
n=28 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants • no underrepresented individuals
|
0 Participants
n=13 Participants • no underrepresented individuals
|
0 Participants
n=26 Participants • no underrepresented individuals
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants • no underrepresented individuals
|
0 Participants
n=13 Participants • no underrepresented individuals
|
0 Participants
n=26 Participants • no underrepresented individuals
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants • no underrepresented individuals
|
0 Participants
n=13 Participants • no underrepresented individuals
|
0 Participants
n=26 Participants • no underrepresented individuals
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=13 Participants • no underrepresented individuals
|
0 Participants
n=13 Participants • no underrepresented individuals
|
0 Participants
n=26 Participants • no underrepresented individuals
|
|
Race (NIH/OMB)
White
|
13 Participants
n=13 Participants • no underrepresented individuals
|
13 Participants
n=13 Participants • no underrepresented individuals
|
26 Participants
n=26 Participants • no underrepresented individuals
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants • no underrepresented individuals
|
0 Participants
n=13 Participants • no underrepresented individuals
|
0 Participants
n=26 Participants • no underrepresented individuals
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants • no underrepresented individuals
|
0 Participants
n=13 Participants • no underrepresented individuals
|
0 Participants
n=26 Participants • no underrepresented individuals
|
|
Region of Enrollment
United States
|
14 participants
n=14 Participants
|
14 participants
n=14 Participants
|
28 participants
n=28 Participants
|
PRIMARY outcome
Timeframe: The RMBPC is assessed 1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)Population: Pre/post intervention
Care recipient frequency of behaviors and caregiver reactions to behavioral symptoms. The scale measures how often a behavior occurs (Frequency, "F") and how much the caregiver reacts to it (Reactivity, "R"). Range for both scales is 0-96, lower scores are better. Subscales are not combined.
Outcome measures
| Measure |
Intervention
n=13 Participants
Caregivers for family members with dementia
|
Care Recipients
n=13 Participants
Persons with dementia
|
|---|---|---|
|
Revised Memory and Behavior Problems Checklist
RMPBC, F Pre
|
NA units on a scale
Standard Deviation NA
The Frequency Scale on the RMBPC is the # of behaviors for the person with dementia and does not apply to the caregivers
|
41.5 units on a scale
Standard Deviation 12
|
|
Revised Memory and Behavior Problems Checklist
RMBPC, F, Post RMBPC, F, post
|
NA units on a scale
Standard Deviation NA
The Frequency Scale on the RMBPC is the # of behaviors for the person with dementia and does not apply to the caregivers
|
39.5 units on a scale
Standard Deviation 13.9
|
|
Revised Memory and Behavior Problems Checklist
RMBPC, R, Pre
|
27.5 units on a scale
Standard Deviation 14.9
|
NA units on a scale
Standard Deviation NA
The Reactivity Scale on the RMBPC is the caregiver's reaction to the behaviors and does not apply to the care recipients
|
|
Revised Memory and Behavior Problems Checklist
RMBPC, R, Post
|
24.7 units on a scale
Standard Deviation 13
|
NA units on a scale
Standard Deviation NA
The Reactivity Scale on the RMBPC is the caregiver's reaction to the behaviors and does not apply to the care recipients
|
PRIMARY outcome
Timeframe: 1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)Population: 1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)
Caregiver depression symptoms, Range 0-30, lower scores indicate less depression (better). Depression is only measured for the caregivers, not the care recipients with dementia (only 1 group)
Outcome measures
| Measure |
Intervention
n=13 Participants
Caregivers for family members with dementia
|
Care Recipients
Persons with dementia
|
|---|---|---|
|
Center for Epidemiological Studies Depression Scale
CESD Pre
|
9.9 units on a scale
Standard Deviation 7.2
|
—
|
|
Center for Epidemiological Studies Depression Scale
CESD Post
|
9.5 units on a scale
Standard Deviation 6.7
|
—
|
SECONDARY outcome
Timeframe: Measured at study entry onlyPopulation: Assesses caregivers desire to place person with dementia
Care partner intention to place person with dementia in care facility. This only applies to caregivers.
Outcome measures
| Measure |
Intervention
n=13 Participants
Caregivers for family members with dementia
|
Care Recipients
Persons with dementia
|
|---|---|---|
|
Desire to Institutionalize (DTI) Scale
Not likely
|
11 Participants
|
—
|
|
Desire to Institutionalize (DTI) Scale
Possibly
|
1 Participants
|
—
|
|
Desire to Institutionalize (DTI) Scale
very Likely
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)Population: The MMCGI is only for caregivers (one group). This scale was not used with persons with dementia.
Caregiver anticipatory grief. Range is 0-90. Higher scores indicate worse grief. This only applies to the caregivers.
Outcome measures
| Measure |
Intervention
n=13 Participants
Caregivers for family members with dementia
|
Care Recipients
Persons with dementia
|
|---|---|---|
|
Marwit Meuser Caregiver Grief Index
Pre intervention
|
60.9 units on a scale
Standard Deviation 14.5
|
—
|
|
Marwit Meuser Caregiver Grief Index
Post intervention
|
58.9 units on a scale
Standard Deviation 12.6
|
—
|
SECONDARY outcome
Timeframe: Measured only once by caregivers 1 week after 8-week interventionPopulation: This is only for the caregivers (one group)
Measures how much participants find the intervention acceptable and feasible. This only applies to caregivers.
Outcome measures
| Measure |
Intervention
n=13 Participants
Caregivers for family members with dementia
|
Care Recipients
Persons with dementia
|
|---|---|---|
|
Feasibility and Participant Acceptability
It was easy for me to attend STELLA Visits
|
12 participants
|
—
|
|
Feasibility and Participant Acceptability
I could talk with the STELLA Guide easily and openly
|
13 participants
|
—
|
|
Feasibility and Participant Acceptability
I feel confident that I can use STELLA skills ot manage upsetting behaviors
|
13 participants
|
—
|
|
Feasibility and Participant Acceptability
I felt my privacy was respected during the STELLA visits
|
13 participants
|
—
|
|
Feasibility and Participant Acceptability
I felt comfortable discussing sensitive topics with my Guide
|
13 participants
|
—
|
|
Feasibility and Participant Acceptability
Comfortable talking with other participants
|
13 participants
|
—
|
|
Feasibility and Participant Acceptability
Easy to find activity for Care recipient
|
11 participants
|
—
|
|
Feasibility and Participant Acceptability
Good Technical support
|
13 participants
|
—
|
|
Feasibility and Participant Acceptability
Could see and hear others
|
12 participants
|
—
|
|
Feasibility and Participant Acceptability
Easy to connect
|
12 participants
|
—
|
|
Feasibility and Participant Acceptability
Liked working with other CPs
|
13 participants
|
—
|
|
Feasibility and Participant Acceptability
Prefer 1:1 for 8 weeks (no group)
|
1 participants
|
—
|
|
Feasibility and Participant Acceptability
Prefer group
|
2 participants
|
—
|
|
Feasibility and Participant Acceptability
Current format
|
10 participants
|
—
|
|
Feasibility and Participant Acceptability
Prefer in-person
|
5 participants
|
—
|
|
Feasibility and Participant Acceptability
Prefer video format
|
8 participants
|
—
|
SECONDARY outcome
Timeframe: 1 week prior to the 8-week intervention (pre), then 1 week after the intervention (post)Quality of life for participants, both for caregivers and persons with dementia. The measure consists of 13 items, rated on a four point scale, with 1 being poor and 4 being excellent. Total scores range from 13 to 52, higher scores are better
Outcome measures
| Measure |
Intervention
n=13 Participants
Caregivers for family members with dementia
|
Care Recipients
n=13 Participants
Persons with dementia
|
|---|---|---|
|
Quality of Life in Alzheimer's Disease (QOL-AD) Scale
QoL Pre
|
37.1 units on a scale
Standard Deviation 5.3
|
33.3 units on a scale
Standard Deviation 7.7
|
|
Quality of Life in Alzheimer's Disease (QOL-AD) Scale
QoL Post
|
35.5 units on a scale
Standard Deviation 6.2
|
34 units on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Measures sleep from enrollment to study end. Mean sleep hours one week prior to intervention (pre) and one week after intervention (post). Measured in hours (units on a scale)Population: sleep duration
Digital behavioral biomarker for effective impact of care on care partner sleep. Measured via electronic sleep mat
Outcome measures
| Measure |
Intervention
n=12 Participants
Caregivers for family members with dementia
|
Care Recipients
n=12 Participants
Persons with dementia
|
|---|---|---|
|
Sleep Duration
pre intervention
|
7.9 hours
Standard Deviation 1.5
|
8.9 hours
Standard Deviation 1.8
|
|
Sleep Duration
post intervention
|
7.8 hours
Standard Deviation 1.8
|
9.2 hours
Standard Deviation 1.3
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Care Recipients
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Intervention
n=14 participants at risk
Caregivers who participated in intervention
|
Care Recipients
n=3 participants at risk；n=14 participants at risk
Care recipients (did not participate in intervention)
|
|---|---|---|
|
Nervous system disorders
Death
|
0.00%
0/14 • Duration of study participation (about 1.3 years)
All caregivers are at low risk for adverse events. They are not "patients" and this is not a study that involves medication. Persons with dementia may have "adverse events" due to their advanced age and dementia status. However, these events are "expected" and not related to the study.
|
7.1%
1/14 • Number of events 1 • Duration of study participation (about 1.3 years)
All caregivers are at low risk for adverse events. They are not "patients" and this is not a study that involves medication. Persons with dementia may have "adverse events" due to their advanced age and dementia status. However, these events are "expected" and not related to the study.
|
|
Musculoskeletal and connective tissue disorders
Hospitalizaton: Fall
|
0.00%
0/14 • Duration of study participation (about 1.3 years)
All caregivers are at low risk for adverse events. They are not "patients" and this is not a study that involves medication. Persons with dementia may have "adverse events" due to their advanced age and dementia status. However, these events are "expected" and not related to the study.
|
14.3%
2/14 • Number of events 2 • Duration of study participation (about 1.3 years)
All caregivers are at low risk for adverse events. They are not "patients" and this is not a study that involves medication. Persons with dementia may have "adverse events" due to their advanced age and dementia status. However, these events are "expected" and not related to the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
0.00%
0/14 • Duration of study participation (about 1.3 years)
All caregivers are at low risk for adverse events. They are not "patients" and this is not a study that involves medication. Persons with dementia may have "adverse events" due to their advanced age and dementia status. However, these events are "expected" and not related to the study.
|
14.3%
2/14 • Number of events 2 • Duration of study participation (about 1.3 years)
All caregivers are at low risk for adverse events. They are not "patients" and this is not a study that involves medication. Persons with dementia may have "adverse events" due to their advanced age and dementia status. However, these events are "expected" and not related to the study.
|
|
Gastrointestinal disorders
Hospitalization GI
|
0.00%
0/14 • Duration of study participation (about 1.3 years)
All caregivers are at low risk for adverse events. They are not "patients" and this is not a study that involves medication. Persons with dementia may have "adverse events" due to their advanced age and dementia status. However, these events are "expected" and not related to the study.
|
14.3%
2/14 • Number of events 2 • Duration of study participation (about 1.3 years)
All caregivers are at low risk for adverse events. They are not "patients" and this is not a study that involves medication. Persons with dementia may have "adverse events" due to their advanced age and dementia status. However, these events are "expected" and not related to the study.
|
|
Psychiatric disorders
Hospitalization: Agitation
|
0.00%
0/14 • Duration of study participation (about 1.3 years)
All caregivers are at low risk for adverse events. They are not "patients" and this is not a study that involves medication. Persons with dementia may have "adverse events" due to their advanced age and dementia status. However, these events are "expected" and not related to the study.
|
14.3%
2/14 • Number of events 2 • Duration of study participation (about 1.3 years)
All caregivers are at low risk for adverse events. They are not "patients" and this is not a study that involves medication. Persons with dementia may have "adverse events" due to their advanced age and dementia status. However, these events are "expected" and not related to the study.
|
Other adverse events
| Measure |
Intervention
n=14 participants at risk
Caregivers who participated in intervention
|
Care Recipients
n=3 participants at risk；n=14 participants at risk
Care recipients (did not participate in intervention)
|
|---|---|---|
|
Psychiatric disorders
care partner burden
|
14.3%
2/14 • Number of events 2 • Duration of study participation (about 1.3 years)
All caregivers are at low risk for adverse events. They are not "patients" and this is not a study that involves medication. Persons with dementia may have "adverse events" due to their advanced age and dementia status. However, these events are "expected" and not related to the study.
|
0.00%
0/3 • Duration of study participation (about 1.3 years)
All caregivers are at low risk for adverse events. They are not "patients" and this is not a study that involves medication. Persons with dementia may have "adverse events" due to their advanced age and dementia status. However, these events are "expected" and not related to the study.
|
|
Respiratory, thoracic and mediastinal disorders
COVID
|
14.3%
2/14 • Number of events 2 • Duration of study participation (about 1.3 years)
All caregivers are at low risk for adverse events. They are not "patients" and this is not a study that involves medication. Persons with dementia may have "adverse events" due to their advanced age and dementia status. However, these events are "expected" and not related to the study.
|
66.7%
2/3 • Number of events 2 • Duration of study participation (about 1.3 years)
All caregivers are at low risk for adverse events. They are not "patients" and this is not a study that involves medication. Persons with dementia may have "adverse events" due to their advanced age and dementia status. However, these events are "expected" and not related to the study.
|
|
Musculoskeletal and connective tissue disorders
Fall
|
14.3%
2/14 • Number of events 2 • Duration of study participation (about 1.3 years)
All caregivers are at low risk for adverse events. They are not "patients" and this is not a study that involves medication. Persons with dementia may have "adverse events" due to their advanced age and dementia status. However, these events are "expected" and not related to the study.
|
33.3%
1/3 • Number of events 1 • Duration of study participation (about 1.3 years)
All caregivers are at low risk for adverse events. They are not "patients" and this is not a study that involves medication. Persons with dementia may have "adverse events" due to their advanced age and dementia status. However, these events are "expected" and not related to the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place