NCT02106065: VACARES

VA Cultivating Access to Resources, Education, and Skills for Dementia Caregivers

Completed NA Results posted Last updated 13 August 2021

What this trial tests

NA trial testing Education and Skill-Building Rehabilitation (ESBR) in Dementia in 32 participants. Completed in 30 September 2019.

Timeline

21 February 2014

Primary endpoint
30 September 2019

30 September 2019

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	32
Start date	21 February 2014
Primary completion	30 September 2019
Estimated completion	30 September 2019
Sites	1 location across United States

Drugs / interventions tested

• Education and Skill-Building Rehabilitation (ESBR)
• Supplemental Education Materials

Conditions studied

• Dementia — all drugs for Dementia →
• Caregivers — all drugs for Caregivers →
• Neurodegenerative Diseases — all drugs for Neurodegenerative Diseases →
• Brain Diseases — all drugs for Brain Diseases →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Dementia or Caregivers. 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 Primary · change from baseline at 6-months post intervention

The Zarit Burden Inventory is a self-report measure of caregiver burden. Higher scores on this assessment indicate greater levels of caregiver burden. Potential scores range from 0-88 with higher scores indicating more severe burden.

Group	Value	95% CI
ESBR-i	2.0	± 2.6
ESBR-v	-0.4	± 5.0
Usual Care	1.6	± 3.0

Center for Epidemiological Studies-Depression Secondary · change from baseline at 6-months

change in caregiver depressive symptoms as measured by the Center for Epidemiological Studies-Depression (CES-D). Scores on the CES-D can range from 0-60 with higher scores suggesting greater depressive symptomatology.

Group	Value	95% CI
ESBR-i	2.0	± 6.9
ESBR-v	0.1	± 3.3
Usual Care	-0.2	± 5.3

Change in All-cause Mortality Status (Care Recipient) Secondary · 6-months post intervention

Based on caregiver interview, care recipient mortality status will be ascertained

Group	Value	95% CI
ESBR-i	1
ESBR-v	0
Usual Care	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 Months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ESBR-i

Serious: 0/6 (0%)

Deaths: 2/6

ESBR-v

Serious: 0/11 (0%)

Deaths: 0/11

Usual Care

Serious: 0/15 (0%)

Deaths: 0/15

Other adverse events (1 terms — click to expand)

Reaction	System	ESBR-i	ESBR-v	Usual Care
Musculoskeletal injury	Musculoskeletal and connective tissue disorders	—	—	—

Data from ClinicalTrials.gov NCT02106065 adverse events section.

Sponsor's own description

The purpose of this study is to study the effects of an education and skill-building intervention on family caregivers of Veterans with dementia.

Publications & conference data

2 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. Telemedicine and the assessment of clinician time: a scoping review.
   Kidholm K, Jensen LK, Johansson M, Montori VM. · · 2023 · cited 16× · PMID 38099431 · DOI 10.1017/s0266462323002830