Trial Outcomes & Findings for Producing a Fully Asynchronous Online Savvy Program (NCT NCT04951037)
NCT ID: NCT04951037
Last Updated: 2024-04-16
Results Overview
The CES-D is a 20-item self-report instrument asking respondents if they have experienced symptoms of depression during the past week. Responses are given on a scale of 0 to 3 where "rarely" = 0 and "most of the time" = 3. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression.
COMPLETED
NA
60 participants
Baseline, Month 2, Month 3
2024-04-16
Participant Flow
Participants were recruited in Atlanta, USA. Participant enrollment began September 15, 2021 and all follow-up assessments were completed by September 2, 2022.
Participant milestones
| Measure |
Fully Asynchronous Online Savvy Program
Family caregivers of a person living with dementia (PLWD) taking part in a fully asynchronous online caregiver education program. The intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants are asked to engage with a fully online version of Tele-Savvy for 42 days.
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|---|---|
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Overall Study
STARTED
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60
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Overall Study
Completed Month 2 Assessment
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46
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Overall Study
Completed Month 3 Assessment
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39
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Overall Study
COMPLETED
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29
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Overall Study
NOT COMPLETED
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31
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Reasons for withdrawal
| Measure |
Fully Asynchronous Online Savvy Program
Family caregivers of a person living with dementia (PLWD) taking part in a fully asynchronous online caregiver education program. The intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants are asked to engage with a fully online version of Tele-Savvy for 42 days.
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|---|---|
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Overall Study
Lost to Follow-up
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16
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Overall Study
Withdrawal by Subject
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5
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Overall Study
Completed study assessments but did not complete the intervention
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10
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Baseline Characteristics
Producing a Fully Asynchronous Online Savvy Program
Baseline characteristics by cohort
| Measure |
Fully Asynchronous Online Savvy Program
n=60 Participants
Family caregivers of PLWD taking part in a fully asynchronous online caregiver education program. The intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants are asked to engage with a fully online version of Tele-Savvy for 42 days.
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|---|---|
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Age, Continuous
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58.217 years
STANDARD_DEVIATION 14.438 • n=93 Participants
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Sex/Gender, Customized
Female
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50 Participants
n=93 Participants
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Sex/Gender, Customized
Male
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9 Participants
n=93 Participants
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Sex/Gender, Customized
Non-binary
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1 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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4 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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55 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=93 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Black or African American
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7 Participants
n=93 Participants
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Race (NIH/OMB)
White
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48 Participants
n=93 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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5 Participants
n=93 Participants
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Region of Enrollment
United States
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60 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Baseline, Month 2, Month 3Population: This analysis includes values for the subset of 29 participants who completed the study intervention and the study assessments. Some participants did not complete the study intervention according to study timelines, but they did remain in the study and complete the assessments. In order to report all available data, values are also included for all study participants who completed the survey at the indicated time points, regardless of whether they completed the intervention.
The CES-D is a 20-item self-report instrument asking respondents if they have experienced symptoms of depression during the past week. Responses are given on a scale of 0 to 3 where "rarely" = 0 and "most of the time" = 3. Total scores range from 0 to 60 and higher scores indicate greater symptoms of depression.
Outcome measures
| Measure |
Fully Asynchronous Online Savvy Program
n=60 Participants
Family caregivers of PLWD taking part in a fully asynchronous online caregiver education program. The intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants are asked to engage with a fully online version of Tele-Savvy for 42 days.
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|---|---|
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Center for Epidemiologic Studies - Depression (CES-D) Score
Baseline among those who completed the Online Savvy Program
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11.483 score on a scale
Standard Deviation 11.009
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Center for Epidemiologic Studies - Depression (CES-D) Score
Month 2 among those who completed the Online Savvy Program
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9.345 score on a scale
Standard Deviation 6.360
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Center for Epidemiologic Studies - Depression (CES-D) Score
Month 3 among those who completed the Online Savvy Program
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8.964 score on a scale
Standard Deviation 8.149
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Center for Epidemiologic Studies - Depression (CES-D) Score
Baseline among those who completed the survey
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14.317 score on a scale
Standard Deviation 11.058
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Center for Epidemiologic Studies - Depression (CES-D) Score
Month 2 among those who completed the survey
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10.848 score on a scale
Standard Deviation 8.200
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Center for Epidemiologic Studies - Depression (CES-D) Score
Month 3 among those who completed the survey
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10.132 score on a scale
Standard Deviation 8.612
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PRIMARY outcome
Timeframe: Baseline, Month 2, Month 3Population: This analysis includes values for the subset of 29 participants who completed the study intervention and the study assessments. Some participants did not complete the study intervention according to study timelines, but they did remain in the study and complete the assessments. In order to report all available data, values are also included for all study participants who completed the survey at the indicated time points, regardless of whether they completed the intervention.
The Zarit Burden Interview is a 22-item scale of objective and subjective caregiver burden. Responses are given on a 5-point scale where 0 = never and 4 = nearly always. Total scores range from 0 to 88 where higher scores indicate greater feelings of being burdened with providing care.
Outcome measures
| Measure |
Fully Asynchronous Online Savvy Program
n=60 Participants
Family caregivers of PLWD taking part in a fully asynchronous online caregiver education program. The intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants are asked to engage with a fully online version of Tele-Savvy for 42 days.
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|---|---|
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Zarit Burden Interview Score
Baseline among those who completed the Online Savvy Program
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31.207 score on a scale
Standard Deviation 12.957
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Zarit Burden Interview Score
Month 2 among those who completed the Online Savvy Program
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29.138 score on a scale
Standard Deviation 10.395
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Zarit Burden Interview Score
Month 3 among those who completed the Online Savvy Program
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26.296 score on a scale
Standard Deviation 9.474
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Zarit Burden Interview Score
Baseline among those who completed the survey
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35.050 score on a scale
Standard Deviation 14.274
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Zarit Burden Interview Score
Month 2 among those who completed the survey
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31.239 score on a scale
Standard Deviation 10.754
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Zarit Burden Interview Score
Month 3 among those who completed the survey
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28.730 score on a scale
Standard Deviation 10.235
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PRIMARY outcome
Timeframe: Baseline, Month 2, Month 3Population: This analysis includes values for the subset of 29 participants who completed the study intervention and the study assessments. Some participants did not complete the study intervention according to study timelines, but they did remain in the study and complete the assessments. In order to report all available data, values are also included for all study participants who completed the survey at the indicated time points, regardless of whether they completed the intervention.
The STAI is a 20-item self-report scale of positive and negative anxiety experiences. Responses are given 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 |
Fully Asynchronous Online Savvy Program
n=60 Participants
Family caregivers of PLWD taking part in a fully asynchronous online caregiver education program. The intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants are asked to engage with a fully online version of Tele-Savvy for 42 days.
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|---|---|
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State-Trait Anxiety Inventory (STAI) Score
Baseline among those who completed the Online Savvy Program
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31.793 score on a scale
Standard Deviation 9.777
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State-Trait Anxiety Inventory (STAI) Score
Month 2 among those who completed the Online Savvy Program
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31.793 score on a scale
Standard Deviation 8.104
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State-Trait Anxiety Inventory (STAI) Score
Month 3 among those who completed the Online Savvy Program
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29.893 score on a scale
Standard Deviation 8.230
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State-Trait Anxiety Inventory (STAI) Score
Baseline among those who completed the survey
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34.862 score on a scale
Standard Deviation 11.190
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State-Trait Anxiety Inventory (STAI) Score
Month 2 among those who completed the survey
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31.761 score on a scale
Standard Deviation 9.053
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State-Trait Anxiety Inventory (STAI) Score
Month 3 among those who completed the survey
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31.103 score on a scale
Standard Deviation 9.167
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PRIMARY outcome
Timeframe: Baseline, Month 2, Month 3Population: Participants with incomplete responses were removed from this analysis. Of the 29 participants who completed the study intervention and assessments, 4 had missing responses for this survey at any time point, resulting in 25 participants analyzed. Values are also included for all study participants responding to surveys at the indicated time points, even if they did not complete the intervention; of these 8 had missing responses on this survey at Baseline and 1 had missing responses at Month 2.
The Caregiving Mastery instrument assesses caregiver mastery of 3 different realms of caregiving situations: Relational Deprivation, Caregiving Competence, and Management of Situation. The Caregiving Competence subscale asks caregivers about their thoughts about the caregiving they provide with 4 items where responses are given on a 4-point scale where "not at all" = 1 and "completely" or "very" = 4. Total scores range from 4 to 16 where higher scores indicate greater feelings of competence with caregiving.
Outcome measures
| Measure |
Fully Asynchronous Online Savvy Program
n=52 Participants
Family caregivers of PLWD taking part in a fully asynchronous online caregiver education program. The intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants are asked to engage with a fully online version of Tele-Savvy for 42 days.
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|---|---|
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Caregiver Mastery Scale - Caregiving Competence Score
Baseline among those who completed the survey
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11.481 score on a scale
Standard Deviation 2.330
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Caregiver Mastery Scale - Caregiving Competence Score
Month 2 among those who completed the survey
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12.689 score on a scale
Standard Deviation 1.998
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Caregiver Mastery Scale - Caregiving Competence Score
Month 3 among those who completed the survey
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13.026 score on a scale
Standard Deviation 2.146
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Caregiver Mastery Scale - Caregiving Competence Score
Baseline among those who completed the Online Savvy Program
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12.160 score on a scale
Standard Deviation 1.700
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Caregiver Mastery Scale - Caregiving Competence Score
Month 2 among those who completed the Online Savvy Program
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12.821 score on a scale
Standard Deviation 1.945
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Caregiver Mastery Scale - Caregiving Competence Score
Month 3 among those who completed the Online Savvy Program
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13.143 score on a scale
Standard Deviation 2.085
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PRIMARY outcome
Timeframe: Baseline, Month 2, Month 3Population: This analysis includes values for the subset of 29 participants who completed the study intervention and the study assessments. Some participants did not complete the study intervention according to study timelines, but they did remain in the study and complete the assessments. In order to report all available data, values are also included for all study participants who completed the survey at the indicated time points, regardless of whether they completed the intervention.
The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate how frequently problems have occurred on a 5-point scale where 0 = never occurred and 4 = daily or more often. Total frequency scores range from 0 to 96 with higher scores indicating greater frequency of memory and behavior problems exhibited by the PLWD.
Outcome measures
| Measure |
Fully Asynchronous Online Savvy Program
n=60 Participants
Family caregivers of PLWD taking part in a fully asynchronous online caregiver education program. The intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants are asked to engage with a fully online version of Tele-Savvy for 42 days.
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|---|---|
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Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score
Baseline among those who completed the Online Savvy Program
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40.276 score on a scale
Standard Deviation 12.015
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Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score
Month 2 among those who completed the Online Savvy Program
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36.345 score on a scale
Standard Deviation 9.529
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Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score
Month 3 among those who completed the Online Savvy Program
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34.786 score on a scale
Standard Deviation 9.796
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Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score
Baseline among those who completed the survey
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40.407 score on a scale
Standard Deviation 13.849
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Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score
Month 2 among those who completed the survey
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35.739 score on a scale
Standard Deviation 10.784
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Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score
Month 3 among those who completed the survey
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34.897 score on a scale
Standard Deviation 9.784
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PRIMARY outcome
Timeframe: Baseline, Month 2, Month 3Population: This analysis includes values for the subset of 29 participants who completed the study intervention and the study assessments. Some participants did not complete the study intervention according to study timelines, but they did remain in the study and complete the assessments. In order to report all available data, values are also included for all study participants who completed the survey at the indicated time points, regardless of whether they completed the intervention.
The RMBPC is a 24-item scale reporting on frequency of disturbing care recipient behaviors and severity or caregiver reactions to these behaviors. Respondents indicate the degree to which problems have bothered or upset them on a 5-point scale where 0 = not at all and 4 = extremely. Total reaction scores range from 0 to 96 with higher scores indicating more bothered or upset by memory and behavior problems exhibited by the PLWD.
Outcome measures
| Measure |
Fully Asynchronous Online Savvy Program
n=60 Participants
Family caregivers of PLWD taking part in a fully asynchronous online caregiver education program. The intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants are asked to engage with a fully online version of Tele-Savvy for 42 days.
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|---|---|
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Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
Baseline among those who completed the Online Savvy Program
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18.483 score on a scale
Standard Deviation 10.534
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Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
Month 2 among those who completed the Online Savvy Program
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12.828 score on a scale
Standard Deviation 7.016
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Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
Month 3 among those who completed the Online Savvy Program
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12.893 score on a scale
Standard Deviation 7.420
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Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
Baseline among those who completed the survey
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20.167 score on a scale
Standard Deviation 12.238
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Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
Month 2 among those who completed the survey
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12.522 score on a scale
Standard Deviation 7.453
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Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
Month 3 among those who completed the survey
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13.132 score on a scale
Standard Deviation 7.977
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Adverse Events
Fully Asynchronous Online Savvy Program
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