Trial Outcomes & Findings for Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems (NCT NCT05080777)
NCT ID: NCT05080777
Last Updated: 2025-02-14
Results Overview
Caregiving competence scale, minimum and maximum values 4-16, higher scores mean greater mastery.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
74 participants
Primary outcome timeframe
pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only)
Results posted on
2025-02-14
Participant Flow
Participant milestones
| Measure |
Tele-Savvy Group
The participants will be enrolled into the Tele-Savvy group. Software analytics monitor caregivers' use of asynchronous material each week.
Tele-Savvy: A low-risk, psychoeducational, group-based intervention, is grounded in social learning and stress process theory and its main goal is to produce improved caregiver mastery over the symptom management skills commonly encountered when supervising and caring at home for an older adult living with ADRD. Over the 7-week program, there are synchronous and asynchronous activities each week. The synchronous portion includes weekly scheduled videoconferences (60-80 min) that serve as an online classroom in which facilitators lead lectures and discussions. Daily, caregivers access online 6- to 15-min prerecorded videos, each focused on one main learning objective. Caregivers can watch the lessons whenever and as often as they wish.
|
Attention Control Group
The participants will be enrolled in the Caregiving During Crisis program. Software analytics monitor caregivers' use of asynchronous material each week.
Caregiving During Crisis (Educational Program): The attention control group will receive the self-guided Caregiving During Crisis program. Caregiving During Crisis is a fully online, asynchronous, professionally designed continuing education course aimed at developing the competency of informal caregivers of community-dwelling persons living with dementia to ensure the safety of that person and themselves during this time of the COVID-19 pandemic. The course, readily accessible by home computer or smartphone, describes methods of home infection control and prevention to create a Safe Home space, strategies for safely leaving and re-entering the home (e.g., to shop), additional strategies for safely allowing service personnel (e.g., home health aides or electricians) and select family members to enter the Safe Home space, and risk management strategies to frame decisions when/if COVID restrictions are relaxed or revoked.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
30
|
|
Overall Study
COMPLETED
|
26
|
10
|
|
Overall Study
NOT COMPLETED
|
18
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems
Baseline characteristics by cohort
| Measure |
Tele-Savvy Group
n=44 Participants
The participants will be enrolled into the Tele-Savvy group. Software analytics monitor caregivers' use of asynchronous material each week.
Tele-Savvy: A low-risk, psychoeducational, group-based intervention, is grounded in social learning and stress process theory and its main goal is to produce improved caregiver mastery over the symptom management skills commonly encountered when supervising and caring at home for an older adult living with ADRD. Over the 7-week program, there are synchronous and asynchronous activities each week. The synchronous portion includes weekly scheduled videoconferences (60-80 min) that serve as an online classroom in which facilitators lead lectures and discussions. Daily, caregivers access online 6- to 15-min prerecorded videos, each focused on one main learning objective. Caregivers can watch the lessons whenever and as often as they wish.
|
Attention Control Group
n=30 Participants
The participants will be enrolled in the Caregiving During Crisis program. Software analytics monitor caregivers' use of asynchronous material each week.
Caregiving During Crisis (Educational Program): The attention control group will receive the self-guided Caregiving During Crisis program. Caregiving During Crisis is a fully online, asynchronous, professionally designed continuing education course aimed at developing the competency of informal caregivers of community-dwelling persons living with dementia to ensure the safety of that person and themselves during this time of the COVID-19 pandemic. The course, readily accessible by home computer or smartphone, describes methods of home infection control and prevention to create a Safe Home space, strategies for safely leaving and re-entering the home (e.g., to shop), additional strategies for safely allowing service personnel (e.g., home health aides or electricians) and select family members to enter the Safe Home space, and risk management strategies to frame decisions when/if COVID restrictions are relaxed or revoked.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 12.1 • n=99 Participants
|
63.7 years
STANDARD_DEVIATION 11.2 • n=107 Participants
|
65.1 years
STANDARD_DEVIATION 11.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=99 Participants
|
30 participants
n=107 Participants
|
74 participants
n=206 Participants
|
|
Marital Status
Married
|
35 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Marital Status
Not Married
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Educational level
High school or some college
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Educational level
College degree
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Educational level
Graduate degree
|
22 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Relationship to person with dementia
Spouse/partner
|
26 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Relationship to person with dementia
Daughter
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Relationship to person with dementia
Son
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Relationship to person with dementia
Sibling
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Relationship to person with dementia
Other family member
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Relationship to person with dementia
Unknown
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Employed for pay outside the home
No
|
30 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Employed for pay outside the home
Yes
|
14 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Difficulty paying for basic needs
Not difficult at all
|
32 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Difficulty paying for basic needs
Not very difficult, somewhat or very difficult
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Primary caregiver
Yes
|
36 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Primary caregiver
No
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only)Population: In the Tele-Savvy group, 40 participants had baseline data, 24 participants had 3-month follow-up data, and 16 participants had 6-month follow-up data. In the Attention Control group, 28 participants had baseline data, 10 participants had 3-month follow-up data, and 8 participants had 6-month follow-up data.
Caregiving competence scale, minimum and maximum values 4-16, higher scores mean greater mastery.
Outcome measures
| Measure |
Tele-Savvy Group
n=40 Participants
The participants will be enrolled into the Tele-Savvy group. Software analytics monitor caregivers' use of asynchronous material each week.
Tele-Savvy: A low-risk, psychoeducational, group-based intervention, is grounded in social learning and stress process theory and its main goal is to produce improved caregiver mastery over the symptom management skills commonly encountered when supervising and caring at home for an older adult living with ADRD. Over the 7-week program, there are synchronous and asynchronous activities each week. The synchronous portion includes weekly scheduled videoconferences (60-80 min) that serve as an online classroom in which facilitators lead lectures and discussions. Daily, caregivers access online 6- to 15-min prerecorded videos, each focused on one main learning objective. Caregivers can watch the lessons whenever and as often as they wish.
|
Attention Control Group
n=28 Participants
The participants will be enrolled in the Caregiving During Crisis program. Software analytics monitor caregivers' use of asynchronous material each week.
Caregiving During Crisis (Educational Program): The attention control group will receive the self-guided Caregiving During Crisis program. Caregiving During Crisis is a fully online, asynchronous, professionally designed continuing education course aimed at developing the competency of informal caregivers of community-dwelling persons living with dementia to ensure the safety of that person and themselves during this time of the COVID-19 pandemic. The course, readily accessible by home computer or smartphone, describes methods of home infection control and prevention to create a Safe Home space, strategies for safely leaving and re-entering the home (e.g., to shop), additional strategies for safely allowing service personnel (e.g., home health aides or electricians) and select family members to enter the Safe Home space, and risk management strategies to frame decisions when/if COVID restrictions are relaxed or revoked.
|
|---|---|---|
|
Change in Caregiver Mastery
Scores at baseline
|
10.9 score on a scale
Standard Deviation 2.1
|
11.5 score on a scale
Standard Deviation 2.0
|
|
Change in Caregiver Mastery
Scores at 3-month follow-up
|
12.4 score on a scale
Standard Deviation 2.0
|
12.0 score on a scale
Standard Deviation 2.0
|
|
Change in Caregiver Mastery
Scores at 6-month follow-up
|
12.7 score on a scale
Standard Deviation 1.3
|
12.8 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only)Population: In the Tele-Savvy group, 43 participants had baseline data, 26 participants had 3-month follow-up data, and 14 participants had 6-month follow-up data. In the Attention Control group, 29 participants had baseline data, 10 participants had 3-month follow-up data, and 8 participants had 6-month follow-up data.
The reactions caregivers have to the behavioral and psychological symptoms expressed by persons living with dementia, were assessed using the Revised Memory and Behavior Problem Checklist (RMBPC). The RMBPC is a 24-item scale capturing caregiver reactions to 24 memory and behavior problems. Scores are computed based on the presence or absence of each problem first, and then for caregiver "reaction" or the extent to which caregivers were "bothered" or "upset" by each endorsed behavior. Reactions are assessed by asking how "upsetting" each behavior is to the caregiver on a Likert scale of 0 to 4 (0 = Not at all, 1= a little, 2 = moderately, 3 = very much, and 4 =extremely). Scores on the scale can range from 0-96, with higher scores meaning a worse outcome.
Outcome measures
| Measure |
Tele-Savvy Group
n=43 Participants
The participants will be enrolled into the Tele-Savvy group. Software analytics monitor caregivers' use of asynchronous material each week.
Tele-Savvy: A low-risk, psychoeducational, group-based intervention, is grounded in social learning and stress process theory and its main goal is to produce improved caregiver mastery over the symptom management skills commonly encountered when supervising and caring at home for an older adult living with ADRD. Over the 7-week program, there are synchronous and asynchronous activities each week. The synchronous portion includes weekly scheduled videoconferences (60-80 min) that serve as an online classroom in which facilitators lead lectures and discussions. Daily, caregivers access online 6- to 15-min prerecorded videos, each focused on one main learning objective. Caregivers can watch the lessons whenever and as often as they wish.
|
Attention Control Group
n=29 Participants
The participants will be enrolled in the Caregiving During Crisis program. Software analytics monitor caregivers' use of asynchronous material each week.
Caregiving During Crisis (Educational Program): The attention control group will receive the self-guided Caregiving During Crisis program. Caregiving During Crisis is a fully online, asynchronous, professionally designed continuing education course aimed at developing the competency of informal caregivers of community-dwelling persons living with dementia to ensure the safety of that person and themselves during this time of the COVID-19 pandemic. The course, readily accessible by home computer or smartphone, describes methods of home infection control and prevention to create a Safe Home space, strategies for safely leaving and re-entering the home (e.g., to shop), additional strategies for safely allowing service personnel (e.g., home health aides or electricians) and select family members to enter the Safe Home space, and risk management strategies to frame decisions when/if COVID restrictions are relaxed or revoked.
|
|---|---|---|
|
Change in Caregiver Reactions
Scores at baseline
|
22.4 score on a scale
Standard Deviation 10.9
|
19.4 score on a scale
Standard Deviation 12.3
|
|
Change in Caregiver Reactions
Scores at 3-month follow-up
|
17.6 score on a scale
Standard Deviation 12.2
|
9.4 score on a scale
Standard Deviation 13.0
|
|
Change in Caregiver Reactions
Scores at 6-month follow-up
|
17.2 score on a scale
Standard Deviation 8.7
|
10.1 score on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: pre-randomization; 3 months post-randomization; and 6 months post-randomization (6-month post randomization for Emory site only)Population: In the Tele-Savvy group, 44 participants had baseline data, 26 participants had 3-month follow-up data, and 15 participants had 6-month follow-up data. In the Attention Control group, 30 participants had baseline data, 10 participants had 3-month follow-up data, and 8 participants had 6-month follow-up data.
The Perceived Stress Scale (PSS) is a 14-item instrument designed to measure the degree to which situations in one's life are appraised as stressful. Higher score reflects higher perceived stress. PSS items were designed to tap the degree to which respondents found their lives unpredictable, uncontrollable, and overloading. The scale also includes a number of direct queries about current levels of experienced stress. Each item is scored from 0 (never) to 4 (very often), for a possible score range of 0-56, with higher scores meaning worse outcomes.
Outcome measures
| Measure |
Tele-Savvy Group
n=44 Participants
The participants will be enrolled into the Tele-Savvy group. Software analytics monitor caregivers' use of asynchronous material each week.
Tele-Savvy: A low-risk, psychoeducational, group-based intervention, is grounded in social learning and stress process theory and its main goal is to produce improved caregiver mastery over the symptom management skills commonly encountered when supervising and caring at home for an older adult living with ADRD. Over the 7-week program, there are synchronous and asynchronous activities each week. The synchronous portion includes weekly scheduled videoconferences (60-80 min) that serve as an online classroom in which facilitators lead lectures and discussions. Daily, caregivers access online 6- to 15-min prerecorded videos, each focused on one main learning objective. Caregivers can watch the lessons whenever and as often as they wish.
|
Attention Control Group
n=30 Participants
The participants will be enrolled in the Caregiving During Crisis program. Software analytics monitor caregivers' use of asynchronous material each week.
Caregiving During Crisis (Educational Program): The attention control group will receive the self-guided Caregiving During Crisis program. Caregiving During Crisis is a fully online, asynchronous, professionally designed continuing education course aimed at developing the competency of informal caregivers of community-dwelling persons living with dementia to ensure the safety of that person and themselves during this time of the COVID-19 pandemic. The course, readily accessible by home computer or smartphone, describes methods of home infection control and prevention to create a Safe Home space, strategies for safely leaving and re-entering the home (e.g., to shop), additional strategies for safely allowing service personnel (e.g., home health aides or electricians) and select family members to enter the Safe Home space, and risk management strategies to frame decisions when/if COVID restrictions are relaxed or revoked.
|
|---|---|---|
|
Change in Caregiver Stress
Scores at baseline
|
25.6 score on a scale
Standard Deviation 6.6
|
24.5 score on a scale
Standard Deviation 9.5
|
|
Change in Caregiver Stress
Scores at 3-month follow-up
|
21.1 score on a scale
Standard Deviation 5.5
|
15.2 score on a scale
Standard Deviation 7.3
|
|
Change in Caregiver Stress
Scores at 6-month follow-up
|
19.9 score on a scale
Standard Deviation 5.7
|
16.8 score on a scale
Standard Deviation 9.2
|
Adverse Events
Tele-Savvy Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Richard Fortinsky
University of Connecticut Center on Aging
Phone: 860-679-8069
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place