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NCT03033875

Testing Tele-Savvy, an On-line Psychoeducation Program for Dementia Family Caregivers

Completed NA Results posted Last updated 13 January 2022
What this trial tests

NA trial testing Tele-Savvy in Alzheimer Disease in 261 participants. Completed in 4 December 2020.

Timeline
18 May 2017
Primary endpoint
4 December 2020
4 December 2020

Quick facts

Lead sponsorEmory University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeother
Enrollment261
Start date18 May 2017
Primary completion4 December 2020
Estimated completion4 December 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Emory University

Who can join

18 and older, any sex, with Alzheimer Disease or 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.

Zarit Burden Inventory (ZBI) Score Primary · Baseline, Month 3, Month 6

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)

Baseline
GroupValue95% CI
Tele-Savvy Group37.34± 13.77
Attention Control Group35.78± 14.66
Usual Care Group35.94± 15.99
Month 3
GroupValue95% CI
Tele-Savvy Group35.26± 13.03
Attention Control Group36.28± 13.49
Usual Care Group37.82± 15.80
Month 6
GroupValue95% CI
Tele-Savvy Group35.54± 13.63
Attention Control Group35.91± 12.96
Usual Care Group37.48± 17.31
State-Trait Anxiety Inventory (STAI) State Score Primary · Baseline, Month 3, Month 6

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.

Baseline
GroupValue95% CI
Tele-Savvy Group35.07± 11.96
Attention Control Group34.61± 13.13
Usual Care Group33.41± 11.61
Month 3
GroupValue95% CI
Tele-Savvy Group32.90± 12.31
Attention Control Group32.96± 11.50
Usual Care Group35.00± 12.15
Month 6
GroupValue95% CI
Tele-Savvy Group31.22± 9.97
Attention Control Group34.07± 11.83
Usual Care Group35.41± 12.93
Center for Epidemiological Studies Depression Scale - Revised (CESD-R) Score Primary · Baseline, Month 3, Month 6

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.

Baseline
GroupValue95% CI
Tele-Savvy Group13.14± 9.98
Attention Control Group12.06± 10.09
Usual Care Group11.08± 8.25
Month 3
GroupValue95% CI
Tele-Savvy Group10.45± 9.23
Attention Control Group10.52± 9.18
Usual Care Group12.07± 8.60
Month 6
GroupValue95% CI
Tele-Savvy Group10.51± 8.16
Attention Control Group11.65± 10.08
Usual Care Group12.93± 9.28
Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score Secondary · Baseline, Month 3, Month 6

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.

Baseline
GroupValue95% CI
Tele-Savvy Group13.84± 9.78
Attention Control Group12.34± 11.89
Usual Care Group13.47± 12.30
Month 3
GroupValue95% CI
Tele-Savvy Group10.36± 7.90
Attention Control Group11.60± 9.01
Usual Care Group14.50± 10.33
Month 6
GroupValue95% CI
Tele-Savvy Group11.30± 8.26
Attention Control Group12.28± 9.82
Usual Care Group15.00± 12.96
Pearlin Mastery, Loss, and Competence - Caregiving Competence Subscale Score Secondary · Baseline, Month 3, Month 6

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.

Baseline
GroupValue95% CI
Tele-Savvy Group12.11± 2.12
Attention Control Group12.44± 1.94
Usual Care Group12.31± 2.14
Month 3
GroupValue95% CI
Tele-Savvy Group13.21± 1.46
Attention Control Group12.49± 1.98
Usual Care Group11.98± 2.27
Month 6
GroupValue95% CI
Tele-Savvy Group13.07± 1.71
Attention Control Group12.62± 2.15
Usual Care Group12.52± 2.19
Pearlin Mastery, Loss, and Competence - Management of Situation Subscale Score Secondary · Baseline, Month 3, Month 6

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.

Baseline
GroupValue95% CI
Tele-Savvy Group11.27± 2.12
Attention Control Group11.63± 2.00
Usual Care Group11.43± 1.93
Month 3
GroupValue95% CI
Tele-Savvy Group12.03± 2.06
Attention Control Group11.35± 2.39
Usual Care Group11.40± 1.56
Month 6
GroupValue95% CI
Tele-Savvy Group11.93± 2.21
Attention Control Group11.78± 1.94
Usual Care Group11.22± 1.59
Perceived Stress Scale (PSS) Score Secondary · Baseline, Month 3, Month 6

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.

Baseline
GroupValue95% CI
Tele-Savvy Group23.50± 8.93
Attention Control Group22.66± 8.21
Usual Care Group21.73± 7.71
Month 3
GroupValue95% CI
Tele-Savvy Group20.77± 6.93
Attention Control Group21.24± 7.63
Usual Care Group23.86± 6.74
Month 6
GroupValue95% CI
Tele-Savvy Group20.72± 7.10
Attention Control Group22.14± 8.08
Usual Care Group23.50± 7.36

Sponsor's own description

The purpose of this study is to test the psychoeducational program "Tele-Savvy." Tele-Savvy is an internet based, group education program developed from an in person program called Savvy Caregiver. Participants will be randomly assigned to either the Tele-Savvy group (receiving only the Tele-Savvy education) or the Healthy Living Education Program (receiving healthy lifestyle education and then Tele-Savvy education 6 months later) or a usual care group (receiving Tele-Savvy education 6 months later). Each program takes 43 days to complete.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Remotely delivered information, training and support for informal caregivers of people with dementia.
    González-Fraile E, Ballesteros J, Rueda JR, Santos-Zorrozúa B, et al · · 2021 · cited 54× · PMID 33417236 · DOI 10.1002/14651858.cd006440.pub3
  2. Testing Tele-Savvy: Protocol for a randomized controlled trial.
    Kovaleva MA, Bilsborough E, Griffiths PC, Nocera J, et al · · 2018 · cited 13× · PMID 29399825 · DOI 10.1002/nur.21859
  3. Using a Warm Hand-Off Approach to Enroll African American Caregivers in a Multi-Site Clinical Trial: The Handshake Protocol.
    Epps F, Brewster G, Phillips JS, Nash R, et al · · 2022 · cited 11× · PMID 33567942 · DOI 10.1177/0733464821992920
  4. Sleep Profiles of Caregivers for Persons Living with Dementia: A Qualitative Study.
    Brewster GS, Pierpaoli Parker C, Epps F, Bonds Johnson K, et al · · 2023 · cited 5× · PMID 37161397 · DOI 10.1177/01939459231175242
  5. Tele-Savvy Outcomes of Non-Hispanic Black American and White Caregivers.
    Bonds Johnson K, Higgins M, Epps F, Brewster GS, et al · · 2024 · cited 5× · PMID 37067896 · DOI 10.1093/geront/gnad044
  6. Program Abstracts from the GSA 2018 Annual Scientific Meeting "The Purposes of Longer Lives".
    · 2018 · cited 3× · PMID 30480150 · DOI 10.1093/geroni/igy023
  7. Attention control in a trial of an online psychoeducational intervention for caregivers.
    Kovaleva M, Nocera JR, Hepburn K, Higgins M, et al · · 2022 · cited 2× · PMID 35080016 · DOI 10.1002/nur.22208
  8. The Effect of Tele-Savvy on Sleep Quality and Insomnia in Caregivers of Persons Living with Dementia.
    Brewster GS, Higgins M, McPhillips MV, Bonds Johnson K, et al · · 2023 · cited 1× · PMID 38111602 · DOI 10.2147/cia.s425741

Verify or expand the search:

Other trials of Tele-Savvy

Trials testing the same drug.

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Data sources for this page

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