CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 319 enrolled
Drug / intervention
Group Delivered TEP +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02368132
NCT02368132N/ACompleted

Comparative Effectiveness of Delivery Methods for Caregiver Support and Education

VA Office of Research and Development·interventional·Posted Feb 20, 2015·Updated Jul 27, 2023

In Brief

A clinical study evaluating Group Delivered TEP and Individual Delivered TEP for Dementia. Completed, enrolled 319 participants across 2 sites.

Detailed Summary

The proposed study seeks to compare usual care and two different interventions for caregivers (CGs) of Veterans with dementia that are brief and administered by telephone. In the first intervention, care management (i.e., assistance from a nurse or social worker who works with the CG and Veteran's primary care providers), support, psychoeducation, and skills training are tailored to each individual CG and delivered on an individual basis. In the second intervention, care management is tailored and delivered to each individual CG, but support, psychoeducation, and skills training are delivered (also by phone) in a group format. This study will allow us to examine the added benefit of participating in a CG group that provides mutual peer support and feedback. The investigators also will evaluate the extent to which spousal vs. adult child CGs respond differently to the two interventions. Findings will help refine patient/CG-centered care management and support programs designed to facilitate access to services and improve the quality of life of Veterans with dementia and their families.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDementia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 20, 2015
Enrollment StartMay 13, 2016
Primary CompletionOct 13, 2020
Study CompletionFeb 24, 2021
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 11.4 years ago

Interventions

Group Delivered TEPbehavioral

All TEP modules will be in a group format. Each call will take 1.5-2 hours. Each group will be comprised of 5-8 CGs who will call into a teleconference line at a pre-specified time. Groups will include spouse/partner-only or adult child-only CGs. The content of the calls will mirror those in the individual TEP delivered program. In addition to the group calls, they will receive individual care management.

Individual Delivered TEPbehavioral

Two mandatory modules that cover the stages of dementia and provide a brief introduction to problem solving techniques, action plan development, and coping skills, plus a menu of additional modules covering various content areas evaluated during the course of the monthly assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, longterm planning, etc.). Each individual TEP session will begin with reviewing education related to the selected module. The remainder of each session will involve coaching the caregiver on emotion-focused and problem focused coping strategies. The care manager will also discuss problem solving with the CG to reinforce the action plan and the educational component of the intervention.