18 and older, any sex, with Dementia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Center for Epidemiologic Studies - Depression (CES-D) ScorePrimary· Baseline, Month 2, Month 3
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.
Baseline among those who completed the Online Savvy Program
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
11.483
± 11.009
Month 2 among those who completed the Online Savvy Program
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
9.345
± 6.360
Month 3 among those who completed the Online Savvy Program
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.
Baseline among those who completed the Online Savvy Program
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
31.207
± 12.957
Month 2 among those who completed the Online Savvy Program
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
29.138
± 10.395
Month 3 among those who completed the Online Savvy Program
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.
Baseline among those who completed the Online Savvy Program
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
31.793
± 9.777
Month 2 among those who completed the Online Savvy Program
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
31.793
± 8.104
Month 3 among those who completed the Online Savvy Program
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.
Baseline among those who completed the Online Savvy Program
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
12.160
± 1.700
Month 2 among those who completed the Online Savvy Program
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
12.821
± 1.945
Month 3 among those who completed the Online Savvy Program
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
13.143
± 2.085
Baseline among those who completed the survey
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
11.481
± 2.330
Month 2 among those who completed the survey
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
12.689
± 1.998
Month 3 among those who completed the survey
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
13.026
± 2.146
Revised Memory and Behavior Problem Checklist (RMBPC) Frequency ScorePrimary· Baseline, Month 2, Month 3
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.
Baseline among those who completed the Online Savvy Program
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
40.276
± 12.015
Month 2 among those who completed the Online Savvy Program
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
36.345
± 9.529
Month 3 among those who completed the Online Savvy Program
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
34.786
± 9.796
Baseline among those who completed the survey
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
40.407
± 13.849
Month 2 among those who completed the survey
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
35.739
± 10.784
Month 3 among those who completed the survey
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
34.897
± 9.784
Revised Memory and Behavior Problem Checklist (RMBPC) Reaction ScorePrimary· Baseline, Month 2, Month 3
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.
Baseline among those who completed the Online Savvy Program
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
18.483
± 10.534
Month 2 among those who completed the Online Savvy Program
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
12.828
± 7.016
Month 3 among those who completed the Online Savvy Program
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
12.893
± 7.420
Baseline among those who completed the survey
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
20.167
± 12.238
Month 2 among those who completed the survey
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
12.522
± 7.453
Month 3 among those who completed the survey
Group
Value
95% CI
Fully Asynchronous Online Savvy Program
13.132
± 7.977
Sponsor's own description
This is a pilot/feasibility study to develop and test a fully online, self-administered psychoeducation program to enhance the caregiving mastery of family and friends who provide unpaid care for persons living with Alzheimer's and similar dementia disorders (PLWD).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Emory University
Last refreshed: 16 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04951037.