Last reviewed · How we verify

NCT05319535

Implementing a Skills-Based Caregiver Training Program (Caregivers FIRST): Function QUERI 2.0

Completed NA Results posted Last updated 16 April 2025
What this trial tests

NA trial testing Implementation Strategy: Foundational REP in Cognitive Function in 25 participants. Completed in 30 September 2024.

Timeline
25 April 2022
Primary endpoint
30 September 2024
30 September 2024

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment25
Start date25 April 2022
Primary completion30 September 2024
Estimated completion30 September 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Eligibility, any sex, with Cognitive Function or Functional Status. 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.

Penetration 1 Primary · 12 months (cumulative)

Penetration is defined as the 1) percentage of caregivers who received consults for VA caregiver education and training services who attended at least one class.

GroupValue95% CI
Foundational REP6.1± 4.5
Enhanced REP8.3± 4.5
Penetration 2 Primary · 12 months (cumulative)

Penetration is defined as the 2) number of classes delivered by site.

GroupValue95% CI
Foundational REP5.5± 4.9
Enhanced REP8.4± 5.6
Fidelity 1 Secondary · 12 months (cumulative)

Fidelity will be measured by 1) the percentage of number of recommended classes delivered by site.

GroupValue95% CI
Foundational REP68.8± 61.4
Enhanced REP104.8± 70.3
Fidelity 2 Secondary · 12 months (cumulative)

Fidelity will be measured by 2) number of caregivers attended at least one class by site.

GroupValue95% CI
Foundational REP1.9± 1.0
Enhanced REP2.4± 0.7
Fidelity 3 Secondary · 12 months (cumulative)

Fidelity will be measured by 3) mean number of classes attended per caregiver.

GroupValue95% CI
Foundational REP11.3± 8.8
Enhanced REP13.2± 8.6
Adoption Secondary · 12 months (cumulative)

Adoption is defined as the number of VA Facilities meeting a threshold of four or more training classes delivered to a minimum of five caregivers.

GroupValue95% CI
Foundational REP6
Enhanced REP10

Sponsor's own description

Implementing a Skills-Based Caregiver Training (Caregivers FIRST): Function QUERI 2.0 aims to compare implementation strategies for large-scale spread of Caregivers FIRST, a group training for friend or family caregivers of Veterans. The goal is to use a type III effectiveness-implementation hybrid design framework to compare continuation of implementation strategies for 24 sites that do not meet implementation adoption benchmarks.

Publications & conference data

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

  1. Intensification of Implementation Strategies: Developing a Model of Foundational and Enhanced Implementation Approaches to Support National Adoption and Scale-up.
    Hughes JM, Zullig LL, Choate AL, Decosimo KP, et al · · 2023 · cited 14× · PMID 36029028 · DOI 10.1093/geront/gnac130
  2. Implementation intensification to disseminate a skills-based caregiver training program: protocol for a type III effectiveness-implementation hybrid trial.
    Decosimo K, Drake C, Coffman CJ, Sperber NR, et al · · 2023 · cited 8× · PMID 37587517 · DOI 10.1186/s43058-023-00475-7
  3. Development and Delivery of Enhanced Implementation Support to Disseminate a National Caregiver Skills Training Program.
    Hughes JM, Makaroun LK, Decosimo K, Tucker M, et al · · 2025 · cited 1× · PMID 39872410 · DOI 10.1093/geroni/igae107

Verify or expand the search:

Other trials of Implementation Strategy: Foundational REP

Trials testing the same drug.

Other recruiting trials for Cognitive Function

Currently open trials in the same condition.

Other VA Office of Research and Development 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/NCT05319535.

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