Clinical trial NCT02021565: Evaluating the CG ASSIST Program for Caregiving Dyads
Official title: Evaluating the CG ASSIST Program for Caregiving Dyads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transfer Impairment
Keywords: Caregivers
Activities of Daily Living
Dementia
Veterans
Self-Help Devices
Telemedicine
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-12-27
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was a wait list control design. Participating couples were either assigned to the intervention group and received the full CG ASSIST program (assessment, observation, recommendations, equipment, modifications, and training) or were assigned to the delayed intervention control group (assessment and observation only). Then, as the intervention group was evaluated, the delayed intervention control group received the full CG ASSIST program. Both groups received 3-month follow-up observations and assessments. Results are reported for Baseline to T1 Intervention and Control.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The CG ASSIST Project is a four-year study for older Veterans with transfer impairments and informal caregivers. CG ASSIST is an in-home training program for dyads designed to teach Veterans how to safely, skillfully, and (when possible) independently perform Activities of Daily Living involving transfers. Experts (OTs) who provide this training will also recommend, provide, and install assistive technology devices such as grab bars, bed rails, and toileting aids as needed. Research assistants conduct home visits with the dyads pre and post intervention to determine the effects of the program on Veteran and caregiver quality of life measures (burden, depression, task efficacy, lifespace).

Half of the couples in this study will receive the training from the expert remotely through a tele-video conferencing device. Research assistants will bring the device to participants' homes and assist in the training session.

Detailed description: Introduction and Objective: The primary objective of the proposed four-year randomized, controlled trial is to document that providing a hands-on skills training and assistive technology (AT)/environmental modification program for older Veterans who are dependent in activities of daily living (ADLs) and their informal caregivers will result in improvements in caregiving processes (i.e., caregiving skills) and outcomes (i.e., safety during tasks) compared to the current standard of care and have beneficial direct and indirect effects for both members of the dyad. Secondary objectives are to determine the effects of the program on Veteran and caregiver subjective well-being (depression, quality of life) and to compare the relative effectiveness of two validated implementation modalities the traditional in-person approach and real-time interactive tele-video conferencing.

Research Plan. The study will be conducted with older Veterans (\>60yrs) with mobility impairments who live in the community and are dependent on an informal caregiver for ADL assistance involving mobility, transfer or positional change. The study will utilize a modified randomized controlled cross-over design with four study arms and three or four outcome assessment periods. Prior to the first home visit, participants will be randomized to an intervention modality (in-person vs. tele-video) then randomized within those groups to an immediate intervention (IIG) or delayed intervention/control group (DICG).

Methods. In-home interviews will be completed with 180 Veteran caregiving dyads to obtain baseline, self-reported measures of caregiving needs, processes and outcomes using standardized, validated instruments. In-home visits by an Assistive Technology Specialist (ATS) will mirror the interview visits (within 1 week) to independently and objectively assess needs through observation of functional tasks. Dyads will be re-evaluated one (T2), two (T3), and four to five (T4) months later to ascertain change. Following T1 assessments, those in the IIG will receive 2 additional home visits from the ATS to (1) deliver the intervention and (2) reinforce the intervention. A 2nd blinded ATS will conduct the T2 outcome assessments. At T2 an ATS will conduct observation-based assessments which will also serve as a repeat baseline for the DICG. The intervention schedule will then be repeated for dyads in the DICG during T3. The final assessments for both groups will be collected 3 months after the intervention during T4.

Intervention. The Caregiver Assessment of Skill Sets \& Individualized Support Thru Training or CG ASSIST program has recently undergone feasibility testing in a VA RR\&D pilot study.

The intervention consists of (a) provision of assistive technology (AT) and simple home modifications to facilitate ADLs and (b) dyad training on the appropriate use of the devices and proper task execution using standardized protocols individualized to the needs and preferences of the dyad and environmental features of the home.

Clinical Relevance. Supporting and assisting caregivers in providing care for Veterans to help them age in place has important implications for the VHA system and the safety, dignity and quality of life of the Veterans we serve.

Eligibility criteria: Inclusion Criteria:

* Veterans 60 who require assistance from the identified caregiver with more than one Activity of Daily Living or three or more Instrumental Activity of Daily Living,
* have a life expectancy of greater than or equal to six (6) months,
* have no plans for transitioning out of home or into hospice in the next six months,
* and have approval from the primary care provider to participate in the research.
* Caregivers must live with the Veteran, provide care four (4) or more days out of the week for at least 6 months,
* and obtain a negative mini-cog assessment. Caregivers can be any relation (spouse, child, sibling, friend, etc.) to the Veteran so long as the two are cohabitating.
* Caregiver can be any age.

Exclusion Criteria:

* Caregivers who have a positive screen with the Mini-Cog fail to demonstrate cognitive capacity to provide informed consent.

Primary outcomes:
measure: Caregiver Transfer Efficacy
timeFrame: T1 Baseline and T2 Post Intervention; 4-6 Weeks
Secondary outcomes:
measure: Veteran Task Efficacy
timeFrame: T1 baseline and T2 Post Intervention; 4-6 weeks
measure: Caregiver Burden
timeFrame: T1 Baseline and T2 Post Intervention; 4-6 Weeks
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
Study officials:
affiliation: Atlanta VA Medical and Rehab Center, Decatur, GA
name: Patricia C Griffiths, PhD
role: PRINCIPAL_INVESTIGATOR
References: