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NCT04951037

Producing a Fully Asynchronous Online Savvy Program

Completed NA Results posted Last updated 16 April 2024
What this trial tests

NA trial testing Fully Asynchronous Online Savvy Program in Dementia in 60 participants. Completed in 2 September 2022.

Timeline
15 September 2021
Primary endpoint
2 September 2022
2 September 2022

Quick facts

Lead sponsorEmory University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment60
Start date15 September 2021
Primary completion2 September 2022
Estimated completion2 September 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Emory University

Who can join

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) Score Primary · 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
GroupValue95% CI
Fully Asynchronous Online Savvy Program11.483± 11.009
Month 2 among those who completed the Online Savvy Program
GroupValue95% CI
Fully Asynchronous Online Savvy Program9.345± 6.360
Month 3 among those who completed the Online Savvy Program
GroupValue95% CI
Fully Asynchronous Online Savvy Program8.964± 8.149
Baseline among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program14.317± 11.058
Month 2 among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program10.848± 8.200
Month 3 among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program10.132± 8.612
Zarit Burden Interview Score Primary · Baseline, Month 2, Month 3

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
GroupValue95% CI
Fully Asynchronous Online Savvy Program31.207± 12.957
Month 2 among those who completed the Online Savvy Program
GroupValue95% CI
Fully Asynchronous Online Savvy Program29.138± 10.395
Month 3 among those who completed the Online Savvy Program
GroupValue95% CI
Fully Asynchronous Online Savvy Program26.296± 9.474
Baseline among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program35.050± 14.274
Month 2 among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program31.239± 10.754
Month 3 among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program28.730± 10.235
State-Trait Anxiety Inventory (STAI) Score Primary · Baseline, Month 2, Month 3

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
GroupValue95% CI
Fully Asynchronous Online Savvy Program31.793± 9.777
Month 2 among those who completed the Online Savvy Program
GroupValue95% CI
Fully Asynchronous Online Savvy Program31.793± 8.104
Month 3 among those who completed the Online Savvy Program
GroupValue95% CI
Fully Asynchronous Online Savvy Program29.893± 8.230
Baseline among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program34.862± 11.190
Month 2 among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program31.761± 9.053
Month 3 among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program31.103± 9.167
Caregiver Mastery Scale - Caregiving Competence Score Primary · Baseline, Month 2, Month 3

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
GroupValue95% CI
Fully Asynchronous Online Savvy Program12.160± 1.700
Month 2 among those who completed the Online Savvy Program
GroupValue95% CI
Fully Asynchronous Online Savvy Program12.821± 1.945
Month 3 among those who completed the Online Savvy Program
GroupValue95% CI
Fully Asynchronous Online Savvy Program13.143± 2.085
Baseline among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program11.481± 2.330
Month 2 among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program12.689± 1.998
Month 3 among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program13.026± 2.146
Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score Primary · 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
GroupValue95% CI
Fully Asynchronous Online Savvy Program40.276± 12.015
Month 2 among those who completed the Online Savvy Program
GroupValue95% CI
Fully Asynchronous Online Savvy Program36.345± 9.529
Month 3 among those who completed the Online Savvy Program
GroupValue95% CI
Fully Asynchronous Online Savvy Program34.786± 9.796
Baseline among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program40.407± 13.849
Month 2 among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program35.739± 10.784
Month 3 among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program34.897± 9.784
Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score Primary · 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
GroupValue95% CI
Fully Asynchronous Online Savvy Program18.483± 10.534
Month 2 among those who completed the Online Savvy Program
GroupValue95% CI
Fully Asynchronous Online Savvy Program12.828± 7.016
Month 3 among those who completed the Online Savvy Program
GroupValue95% CI
Fully Asynchronous Online Savvy Program12.893± 7.420
Baseline among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program20.167± 12.238
Month 2 among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program12.522± 7.453
Month 3 among those who completed the survey
GroupValue95% CI
Fully Asynchronous Online Savvy Program13.132± 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.

Verify or expand the search:

Other recruiting trials for Dementia

Currently open trials in the same condition.

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Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing