Evaluating the CG ASSIST Program for Caregiving Dyads

NCT02021565 | Completed Results

• 2 other identifiers: D7873-R00050313
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Transfer Impairment

Keywords

Caregivers; Activities of Daily Living; Dementia; Veterans; Self-Help Devices; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Caregiver Transfer Efficacy

  Caregiver reported the level of confidence that Veteran care recipient can perform 10 activity of daily living tasks rated on scale of 1-10. Efficacy in task completion reported both with assistance from the informal caregiver and performed independently by the Veteran. Scores range from 10-100 with higher scores reflecting greater transfer efficacy.

  T1 Baseline and T2 Post Intervention; 4-6 Weeks

Secondary Outcomes (2)

• Veteran Task Efficacy

  T1 baseline and T2 Post Intervention; 4-6 weeks

• Caregiver Burden

  T1 Baseline and T2 Post Intervention; 4-6 Weeks

Study Arms (2)

Immediate Intervention Group

EXPERIMENTAL

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.

Behavioral: Immediate Intervention Group

Delayed Intervention Control Group

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.

Other: Delayed Intervention Control Group

Interventions

Immediate Intervention Group 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.

Also known as: In-home Training and Provision of AT (prn)

Immediate Intervention Group

Delayed Intervention Control Group 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.

Also known as: Delayed In-home Training and Provision of AT (prn)

Delayed Intervention Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

The small sample size led to decreased power to detect a difference in the outcomes of interest so results should be interpreted with caution.

Results Point of Contact

• Title: Patricia C. Griffiths
• Organization: Atlanta VA Medical Center

Patricia.Griffiths@va.gov

404-321-6111

Study Officials

• Patricia C Griffiths, PhD

  Atlanta VA Medical and Rehab Center, Decatur, GA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The objective outcomes assessor did not know whether the participants were in the intervention or control group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 27, 2013
• Study Start: December 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 1, 2018
• Results First Posted: March 1, 2018

Record last verified: 2018-02

Locations

US (1)