Trial Outcomes & Findings for Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers (NCT NCT03033875)
NCT ID: NCT03033875
Last Updated: 2022-01-13
Results Overview
The ZBI is a 22 item scale. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total scores range from 0 (low burden) to 88 (high burden)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
261 participants
Primary outcome timeframe
Baseline, Month 3, Month 6
Results posted on
2022-01-13
Participant Flow
Participant enrollment began May 18, 2017 and all study follow up was completed by December 4, 2020. Data collection to assess the outcome measures for this study occurred through the interview at month 6. Study activities continued through month 12 while participants in the Attention Control and Usual Care groups had the opportunity to have the Tele-Savvy intervention.
Participant milestones
| Measure |
Tele-Savvy Group
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.
The Tele-Savvy program engages groups of six dementia family caregivers in a program that extends over 43 days. The program begins with a scheduled 75-minute group videoconference led by facilitators; similar group videoconferences then take place weekly for six weeks. In between the video-conferences, caregivers receive daily emails with links to 5-15 minute on-line video lessons that can be watched on their own schedule as often as they wish. The videoconferences allow caregivers to report enactment of learned and self-developed management strategy behaviors into their own caregiving and allow them to raise questions. Each daily video presents a teaching point linked to the overall curriculum. The lesson is carried forward by brief, scripted talks by experts or is enacted in vignettes in which a fictional family caring for a father living with Alzheimer's demonstrates effective caregiving techniques linked to the day's teaching points.
|
Attention Control Group
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
The Healthy Living Education Program contains video and text materials on exercise, diet, and healthy living. Participants are asked to log into the Canvas site daily over the course of six weeks to view the videos. Each participant also receives 7 weekly brief scripted phone or video calls from a project facilitator to inquire about participants' use of the materials. Additionally, all participants convene weekly for a video conference centered on the application of healthy living strategies. Facilitators greet and check in with each of the caregivers, coach and debrief caregivers on the homework, answer questions and/or respond to feedback about the week's material, review key points and concepts from the week's video sessions and introduce new material, report on any activities that caregivers may have implemented based on the materials, and provide homework assignments.
|
Usual Care Group
Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
96
|
111
|
54
|
|
Overall Study
Completed Month 3 Assessment
|
71
|
83
|
43
|
|
Overall Study
Completed Month 6 Assessment
|
73
|
81
|
46
|
|
Overall Study
COMPLETED
|
77
|
87
|
42
|
|
Overall Study
NOT COMPLETED
|
19
|
24
|
12
|
Reasons for withdrawal
| Measure |
Tele-Savvy Group
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.
The Tele-Savvy program engages groups of six dementia family caregivers in a program that extends over 43 days. The program begins with a scheduled 75-minute group videoconference led by facilitators; similar group videoconferences then take place weekly for six weeks. In between the video-conferences, caregivers receive daily emails with links to 5-15 minute on-line video lessons that can be watched on their own schedule as often as they wish. The videoconferences allow caregivers to report enactment of learned and self-developed management strategy behaviors into their own caregiving and allow them to raise questions. Each daily video presents a teaching point linked to the overall curriculum. The lesson is carried forward by brief, scripted talks by experts or is enacted in vignettes in which a fictional family caring for a father living with Alzheimer's demonstrates effective caregiving techniques linked to the day's teaching points.
|
Attention Control Group
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
The Healthy Living Education Program contains video and text materials on exercise, diet, and healthy living. Participants are asked to log into the Canvas site daily over the course of six weeks to view the videos. Each participant also receives 7 weekly brief scripted phone or video calls from a project facilitator to inquire about participants' use of the materials. Additionally, all participants convene weekly for a video conference centered on the application of healthy living strategies. Facilitators greet and check in with each of the caregivers, coach and debrief caregivers on the homework, answer questions and/or respond to feedback about the week's material, review key points and concepts from the week's video sessions and introduce new material, report on any activities that caregivers may have implemented based on the materials, and provide homework assignments.
|
Usual Care Group
Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
9
|
4
|
|
Overall Study
Other
|
14
|
15
|
8
|
Baseline Characteristics
Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers
Baseline characteristics by cohort
| Measure |
Tele-Savvy Group
n=96 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.
|
Attention Control Group
n=111 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
Usual Care Group
n=54 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
Total
n=261 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 10.9 • n=93 Participants
|
63.8 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
63.7 years
STANDARD_DEVIATION 10.7 • n=27 Participants
|
64.6 years
STANDARD_DEVIATION 11.2 • n=483 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
184 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
38 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
77 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=93 Participants
|
104 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
250 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Caregiver race · White
|
78 Participants
n=93 Participants
|
75 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
192 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Caregiver race · African American/Black
|
15 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
57 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Caregiver race · Asian
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Caregiver race · No answer
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Caregiver race · Other
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
96 Participants
n=93 Participants
|
111 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
261 Participants
n=483 Participants
|
|
Age of person cared for
|
75.1 years
STANDARD_DEVIATION 8.6 • n=93 Participants
|
74.4 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
74.4 years
STANDARD_DEVIATION 10.3 • n=27 Participants
|
74.6 years
STANDARD_DEVIATION 9.8 • n=483 Participants
|
|
Relation to person cared for
Spouse
|
69 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
172 Participants
n=483 Participants
|
|
Relation to person cared for
Non-spouse
|
27 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
89 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. Some questionnaires had missing or skipped items resulting in removing those participants from the analysis.
The ZBI is a 22 item scale. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total scores range from 0 (low burden) to 88 (high burden)
Outcome measures
| Measure |
Tele-Savvy Group
n=96 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.
|
Attention Control Group
n=111 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
Usual Care Group
n=54 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
|---|---|---|---|
|
Zarit Burden Inventory (ZBI) Score
Baseline
|
37.34 score on a scale
Standard Deviation 13.77
|
35.78 score on a scale
Standard Deviation 14.66
|
35.94 score on a scale
Standard Deviation 15.99
|
|
Zarit Burden Inventory (ZBI) Score
Month 3
|
35.26 score on a scale
Standard Deviation 13.03
|
36.28 score on a scale
Standard Deviation 13.49
|
37.82 score on a scale
Standard Deviation 15.80
|
|
Zarit Burden Inventory (ZBI) Score
Month 6
|
35.54 score on a scale
Standard Deviation 13.63
|
35.91 score on a scale
Standard Deviation 12.96
|
37.48 score on a scale
Standard Deviation 17.31
|
PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. One questionnaire had missing or skipped items resulting in one participant being removed from the analysis.
The STAI State (STAI-S) is a 20-item 4-point Likert scale commonly used measure of state anxiety. Respondents report the intensity of their anxiety at that moment on a 4-point scale where 1 = not at all and 4 = very much so. Total scores range from 20 to 80 and higher scores indicate greater anxiety.
Outcome measures
| Measure |
Tele-Savvy Group
n=96 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.
|
Attention Control Group
n=111 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
Usual Care Group
n=54 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
|---|---|---|---|
|
State-Trait Anxiety Inventory (STAI) State Score
Baseline
|
35.07 score on a scale
Standard Deviation 11.96
|
34.61 score on a scale
Standard Deviation 13.13
|
33.41 score on a scale
Standard Deviation 11.61
|
|
State-Trait Anxiety Inventory (STAI) State Score
Month 3
|
32.90 score on a scale
Standard Deviation 12.31
|
32.96 score on a scale
Standard Deviation 11.50
|
35.00 score on a scale
Standard Deviation 12.15
|
|
State-Trait Anxiety Inventory (STAI) State Score
Month 6
|
31.22 score on a scale
Standard Deviation 9.97
|
34.07 score on a scale
Standard Deviation 11.83
|
35.41 score on a scale
Standard Deviation 12.93
|
PRIMARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. One questionnaire had missing or skipped items resulting in one participant being removed from the analysis.
The CESD-R is a 20 item Likert scale scored 0-3 with somatic and psychological subscales. Total scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Outcome measures
| Measure |
Tele-Savvy Group
n=96 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.
|
Attention Control Group
n=111 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
Usual Care Group
n=54 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
|---|---|---|---|
|
Center for Epidemiological Studies Depression Scale - Revised (CESD-R) Score
Baseline
|
13.14 score on a scale
Standard Deviation 9.98
|
12.06 score on a scale
Standard Deviation 10.09
|
11.08 score on a scale
Standard Deviation 8.25
|
|
Center for Epidemiological Studies Depression Scale - Revised (CESD-R) Score
Month 3
|
10.45 score on a scale
Standard Deviation 9.23
|
10.52 score on a scale
Standard Deviation 9.18
|
12.07 score on a scale
Standard Deviation 8.60
|
|
Center for Epidemiological Studies Depression Scale - Revised (CESD-R) Score
Month 6
|
10.51 score on a scale
Standard Deviation 8.16
|
11.65 score on a scale
Standard Deviation 10.08
|
12.93 score on a scale
Standard Deviation 9.28
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. Some questionnaires had missing or skipped items resulting in removing those participants from the analysis.
The RMBPC is a 24-item instrument that assesses behaviors in persons with dementia and caregiver responses to them. Caregiver reactions to behaviors are scored as 0 = not at all upsetting to 4 = extremely upsetting. Total caregiver reaction scores range from 0 to 96 with higher scores indicating greater feelings of being upset by behaviors of those with dementia that they are providing care for.
Outcome measures
| Measure |
Tele-Savvy Group
n=96 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.
|
Attention Control Group
n=110 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
Usual Care Group
n=53 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
|---|---|---|---|
|
Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
Month 3
|
10.36 score on a scale
Standard Deviation 7.90
|
11.60 score on a scale
Standard Deviation 9.01
|
14.50 score on a scale
Standard Deviation 10.33
|
|
Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
Month 6
|
11.30 score on a scale
Standard Deviation 8.26
|
12.28 score on a scale
Standard Deviation 9.82
|
15.00 score on a scale
Standard Deviation 12.96
|
|
Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
Baseline
|
13.84 score on a scale
Standard Deviation 9.78
|
12.34 score on a scale
Standard Deviation 11.89
|
13.47 score on a scale
Standard Deviation 12.30
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. One questionnaire had missing or skipped items resulting in one participant being removed from the analysis.
The Caregiving Competence Subscale of the Pearlin Mastery, Loss, and Competence instrument has 4 items that are responded to on a 4-point Likert scale where 1 = not at all and 4 = very much. Total scores for this subscale range from 4 to 16 and higher scores indicate greater feelings of competence with caregiving.
Outcome measures
| Measure |
Tele-Savvy Group
n=96 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.
|
Attention Control Group
n=111 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
Usual Care Group
n=54 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
|---|---|---|---|
|
Pearlin Mastery, Loss, and Competence - Caregiving Competence Subscale Score
Baseline
|
12.11 score on a scale
Standard Deviation 2.12
|
12.44 score on a scale
Standard Deviation 1.94
|
12.31 score on a scale
Standard Deviation 2.14
|
|
Pearlin Mastery, Loss, and Competence - Caregiving Competence Subscale Score
Month 3
|
13.21 score on a scale
Standard Deviation 1.46
|
12.49 score on a scale
Standard Deviation 1.98
|
11.98 score on a scale
Standard Deviation 2.27
|
|
Pearlin Mastery, Loss, and Competence - Caregiving Competence Subscale Score
Month 6
|
13.07 score on a scale
Standard Deviation 1.71
|
12.62 score on a scale
Standard Deviation 2.15
|
12.52 score on a scale
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. One questionnaire had missing or skipped items resulting in one participant being removed from the analysis.
The Management of Situation Subscale of the Pearlin Mastery, Loss, and Competence instrument has 4 items that are responded to on a 4-point Likert scale where 1 = never and 4 = very often. Total scores for this subscale range from 4 to 16 and higher scores indicate greater management of caregiving situations.
Outcome measures
| Measure |
Tele-Savvy Group
n=96 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.
|
Attention Control Group
n=111 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
Usual Care Group
n=54 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
|---|---|---|---|
|
Pearlin Mastery, Loss, and Competence - Management of Situation Subscale Score
Baseline
|
11.27 score on a scale
Standard Deviation 2.12
|
11.63 score on a scale
Standard Deviation 2.00
|
11.43 score on a scale
Standard Deviation 1.93
|
|
Pearlin Mastery, Loss, and Competence - Management of Situation Subscale Score
Month 3
|
12.03 score on a scale
Standard Deviation 2.06
|
11.35 score on a scale
Standard Deviation 2.39
|
11.40 score on a scale
Standard Deviation 1.56
|
|
Pearlin Mastery, Loss, and Competence - Management of Situation Subscale Score
Month 6
|
11.93 score on a scale
Standard Deviation 2.21
|
11.78 score on a scale
Standard Deviation 1.94
|
11.22 score on a scale
Standard Deviation 1.59
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: This analysis includes participants completing the indicated study visit, who also had valid data for this assessment. Some questionnaires had missing or skipped items resulting in removing those participants from the analysis.
The PSS is 14-item Likert-type questionnaire. Responses are given on a 5-point scale where 0 = never and 4 = very often. Total scores range from 0 to 56 and certain items are reverse scored so that higher total scores reflect higher perceived stress.
Outcome measures
| Measure |
Tele-Savvy Group
n=96 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Tele-Savvy program immediately.
|
Attention Control Group
n=111 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to participate in the Healthy Living Education Program. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
Usual Care Group
n=54 Participants
Informal caregivers of persons living with Alzheimer's disease randomized to continue to receive care through whatever arrangement has been in place. Persons in this group were able to participate in the Tele-Savvy intervention after a delay of 6 months.
|
|---|---|---|---|
|
Perceived Stress Scale (PSS) Score
Month 6
|
20.72 score on a scale
Standard Deviation 7.10
|
22.14 score on a scale
Standard Deviation 8.08
|
23.50 score on a scale
Standard Deviation 7.36
|
|
Perceived Stress Scale (PSS) Score
Baseline
|
23.50 score on a scale
Standard Deviation 8.93
|
22.66 score on a scale
Standard Deviation 8.21
|
21.73 score on a scale
Standard Deviation 7.71
|
|
Perceived Stress Scale (PSS) Score
Month 3
|
20.77 score on a scale
Standard Deviation 6.93
|
21.24 score on a scale
Standard Deviation 7.63
|
23.86 score on a scale
Standard Deviation 6.74
|
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
Usual Care 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place