Evaluating the CG ASSIST Program for Caregiving Dyads

NCT ID: NCT02021565

Last Updated: 2018-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-06-30

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.

Conditions

Transfer Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Immediate Intervention Group

Receives the in-home training intervention immediately after completing the baseline assessment.

The intervention includes three home visits from an AT Specialist (Occupational or Physical Therapist) who observes the dyad perform three ADL transfers, provides recommendations, equipment, home modifications, training, and follow-up training as needed.

Group Type: EXPERIMENTAL

Immediate Intervention Group

Intervention Type: BEHAVIORAL

Assistive Technology (AT) Specialists, experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform three activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, AT Specialists also recommend assistive technology equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, AT Specialists provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods.

Delayed Intervention Control Group

Receives the in-home training intervention six weeks after completing the initial baseline assessment. This allows for a control comparison group while still providing the intervention to all participants.

Group Type: OTHER

Delayed Intervention Control Group

Intervention Type: OTHER

Receives the in-home training intervention six weeks after completing the initial baseline assessment. This allows for a control comparison group while still providing the intervention to all participants.

Interventions

Immediate Intervention Group

Assistive Technology (AT) Specialists, experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform three activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, AT Specialists also recommend assistive technology equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, AT Specialists provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods.

Intervention Type: BEHAVIORAL

Delayed Intervention Control Group

Receives the in-home training intervention six weeks after completing the initial baseline assessment. This allows for a control comparison group while still providing the intervention to all participants.

Intervention Type: OTHER

Other Intervention Names

In-home Training and Provision of AT (prn); Delayed In-home Training and Provision of AT (prn)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia C Griffiths, PhD

Role: PRINCIPAL_INVESTIGATOR

Atlanta VA Medical and Rehab Center, Decatur, GA

Locations

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

Countries

United States

Other Identifiers

00050313

Identifier Type: OTHER

Identifier Source: secondary_id

D7873-R

Identifier Type: -

Identifier Source: org_study_id