Evaluating the CG ASSIST Program for Caregiving Dyads

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT02021565
First received: December 12, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Transfer Impairment
Behavioral: In-home Training and Provision of Assistive Technology (prn)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluating the CG ASSIST Program for Caregiving Dyads

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Assistance Provided - Subjective - Caregiver [ Time Frame: Change from Baseline in Assistance Provided reported by Caregiver at post-intervention, 1 month, and 3 months ] [ Designated as safety issue: No ]
    This outcome is a self-report from the Caregiver of the level of assistance provided to the Veteran to complete three tasks (transferring in and out of bed, toileting, and bathing) using a modified version for the Functional Independence Measure.


Secondary Outcome Measures:
  • Assistance Provided - Subjective - Veteran [ Time Frame: Week 1, 6, 10 and either 19 or 23 ] [ Designated as safety issue: No ]
    This outcome is a self-report from the Veteran of the level of assistance provided by the Caregiver using a modified version for the Functional Independence Measure.

  • Assistance Provided - Objective [ Time Frame: Week 2, 5, 9, and either 18 or 22 ] [ Designated as safety issue: No ]
    This outcome is an objective report from the Assistive Technology Specialist (expert who conducts training) of the level of assistance provided to the Veteran using a modified version of the Functional Independence Measure.

  • Assistance Needed - Subjective - Caregiver [ Time Frame: Week 1, 6, 10, and either 19 or 23 ] [ Designated as safety issue: No ]
    This outcome is a self-report from the Caregiver of the level of assistance the Veteran needs to complete three tasks (transferring in and out of bed, toileting, and bathing) using a modified version of the Functional Independence Measure.

  • Assistance Needed - Subjective - Veteran [ Time Frame: Week 1, 6, 10, and either 19 or 23 ] [ Designated as safety issue: No ]
    This outcome is a self-report from the Veteran of the level of assistance needed from the Caregiver to complete three tasks (transferring in and out of bed, toileting, and bathing) using a modified version of the Functional Independence Measure.

  • Assistance Needed - Objective [ Time Frame: Week 2, 5, 9, and either 18 or 22 ] [ Designated as safety issue: No ]
    This outcome is an objective report from the Assistive Technology Specialist (expert who conducts training) of the level of assistance needed by the Veteran to complete three tasks (transferring in and out of bed, toileting, and bathing) using a modified version of the Functional Independence Measure.


Estimated Enrollment: 180
Study Start Date: December 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immediate Intervention Group
Receives the in-home training intervention immediately after completing the baseline assessment.
Behavioral: In-home Training and Provision of Assistive Technology (prn)
Assistive Technology Specialists (ATSs), experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform four activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, ATSs 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, ATSs 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.
Behavioral: In-home Training and Provision of Assistive Technology (prn)
Assistive Technology Specialists (ATSs), experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform four activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, ATSs 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, ATSs provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods.
In-person Group
Receives the in-home training intervention in a traditional face-to-face format.
Behavioral: In-home Training and Provision of Assistive Technology (prn)
Assistive Technology Specialists (ATSs), experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform four activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, ATSs 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, ATSs provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods.
Tele Group
Receives the in-home training intervention via a tele-video communication device brought to the home by a research assistant. The expert conducts the training remotely observing and training the participants through a tele-rehabilitation device.
Behavioral: In-home Training and Provision of Assistive Technology (prn)
Assistive Technology Specialists (ATSs), experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform four activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, ATSs 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, ATSs provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods.

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 co-habitating.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02021565

Contacts
Contact: Patricia C Griffiths, PhD (404) 321-6111 ext 7138 pcgriff@emory.edu
Contact: Ashley Harrill (404) 321-6111 ext 1191 Ashley.Harrill@va.gov

Locations
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA Recruiting
Decatur, Georgia, United States, 30033
Contact: Patricia C Griffiths, PhD    404-321-6111 ext 7138    pcgriff@emory.edu   
Contact: Ashley Harrill    (404) 321-6111 ext 1191    Ashley.Harrill@va.gov   
Principal Investigator: Patricia C Griffiths, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Patricia C Griffiths, PhD Atlanta VA Medical and Rehab Center, Decatur, GA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT02021565     History of Changes
Other Study ID Numbers: D7873-R, D7873R
Study First Received: December 12, 2013
Last Updated: June 26, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Caregivers
Activities of Daily Living
Dementia
Veterans
Self-Help Devices
Telemedicine

ClinicalTrials.gov processed this record on September 22, 2014