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NCT05080777

Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems

Completed NA Results posted Last updated 14 February 2025
What this trial tests

NA trial testing Tele-Savvy in Alzheimer Disease in 74 participants. Completed in 5 June 2023.

Timeline
28 September 2021
Primary endpoint
5 June 2023
5 June 2023

Quick facts

Lead sponsorUConn Health
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeother
Enrollment74
Start date28 September 2021
Primary completion5 June 2023
Estimated completion5 June 2023
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

UConn Health — full company profile →

Who can join

Adults 18 to 110, 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.

Change in Caregiver Mastery Primary · pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only)

Caregiving competence scale, minimum and maximum values 4-16, higher scores mean greater mastery.

Scores at baseline
GroupValue95% CI
Tele-Savvy Group10.9± 2.1
Attention Control Group11.5± 2.0
Scores at 3-month follow-up
GroupValue95% CI
Tele-Savvy Group12.4± 2.0
Attention Control Group12.0± 2.0
Scores at 6-month follow-up
GroupValue95% CI
Tele-Savvy Group12.7± 1.3
Attention Control Group12.8± 2.7
Change in Caregiver Reactions Secondary · pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only)

The reactions caregivers have to the behavioral and psychological symptoms expressed by persons living with dementia, were assessed using the Revised Memory and Behavior Problem Checklist (RMBPC). The RMBPC is a 24-item scale capturing caregiver reactions to 24 memory and behavior problems. Scores are computed based on the presence or absence of each problem first, and then for caregiver "reaction" or the extent to which caregivers were "bothered" or "upset" by each endorsed behavior. Reactions are assessed by asking how "upsetting" each behavior is to the caregiver on a Likert scale of 0 to 4

Scores at baseline
GroupValue95% CI
Tele-Savvy Group22.4± 10.9
Attention Control Group19.4± 12.3
Scores at 3-month follow-up
GroupValue95% CI
Tele-Savvy Group17.6± 12.2
Attention Control Group9.4± 13.0
Scores at 6-month follow-up
GroupValue95% CI
Tele-Savvy Group17.2± 8.7
Attention Control Group10.1± 7.3
Change in Caregiver Stress Secondary · pre-randomization; 3 months post-randomization; and 6 months post-randomization (6-month post randomization for Emory site only)

The Perceived Stress Scale (PSS) is a 14-item instrument designed to measure the degree to which situations in one's life are appraised as stressful. Higher score reflects higher perceived stress. PSS items were designed to tap the degree to which respondents found their lives unpredictable, uncontrollable, and overloading. The scale also includes a number of direct queries about current levels of experienced stress. Each item is scored from 0 (never) to 4 (very often), for a possible score range of 0-56, with higher scores meaning worse outcomes.

Scores at baseline
GroupValue95% CI
Tele-Savvy Group25.6± 6.6
Attention Control Group24.5± 9.5
Scores at 3-month follow-up
GroupValue95% CI
Tele-Savvy Group21.1± 5.5
Attention Control Group15.2± 7.3
Scores at 6-month follow-up
GroupValue95% CI
Tele-Savvy Group19.9± 5.7
Attention Control Group16.8± 9.2

Sponsor's own description

This cluster randomized pragmatic clinical trial will test the effectiveness and feasibility of embedding the Tele-Savvy intervention, a psychoeducational program for family and other informal caregivers of older adults living in the community with Alzheimer's disease and related dementia (ADRD), in two health care systems/clinical sites: UConn Health in Farmington, Connecticut, and Emory Healthcare in Atlanta, Georgia.

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 trials of Tele-Savvy

Trials testing the same drug.

Other recruiting trials for Alzheimer Disease

Currently open trials in the same condition.

Other UConn Health trials

Trials by the same sponsor.

Verify against primary sources

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/NCT05080777.

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