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Evaluating the CG ASSIST Program for Caregiving Dyads (CG ASSIST)

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ClinicalTrials.gov Identifier: NCT02021565
Recruitment Status : Completed
First Posted : December 27, 2013
Results First Posted : March 1, 2018
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

December 12, 2013
December 27, 2013
August 3, 2017
March 1, 2018
March 1, 2018
December 2013
June 2016   (Final data collection date for primary outcome measure)
Caregiver Transfer Efficacy [ Time Frame: T1 Baseline and T2 Post Intervention; 4-6 Weeks ]
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.
Assistance Provided - Subjective - Caregiver [ Time Frame: Change from Baseline in Assistance Provided reported by Caregiver at post-intervention, 1 month, and 3 months ]
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.
Complete list of historical versions of study NCT02021565 on ClinicalTrials.gov Archive Site
  • Veteran Task Efficacy [ Time Frame: T1 baseline and T2 Post Intervention; 4-6 weeks ]
    Veteran care recipient reported confidence in the performance of 10 activity of daily living tasks rated on scale of 1-10. Items are assessed for efficacy with and without (independently) assistance provided from a caregiver. Scores range from 10-100 with higher scores reflecting greater task efficacy.
  • Caregiver Burden [ Time Frame: T1 Baseline and T2 Post Intervention; 4-6 Weeks ]
    Zarit Burden Interview Revised -indicating caregiver burden. Caregivers endorse 22 items using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Higher scores reflect greater caregiver burden. Scores range from 0 to 88.
  • Assistance Provided - Subjective - Veteran [ Time Frame: Week 1, 6, 10 and either 19 or 23 ]
    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 ]
    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 for the Functional Independence Measure.
  • Assistance Needed - Subjective - Caregiver [ Time Frame: Week 1, 6, 10, and either 19 or 23 ]
    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 for the Functional Independence Measure.
  • Assistance Needed - Subjective - Veteran [ Time Frame: Week 1, 6, 10, and either 19 or 23 ]
    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 for the Functional Independence Measure.
  • Assistance Needed - Objective [ Time Frame: Week 2, 5, 9, and either 18 or 22 ]
    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 for the Functional Independence Measure.
Not Provided
Not Provided
 
Evaluating the CG ASSIST Program for Caregiving Dyads
Evaluating the CG ASSIST Program for Caregiving Dyads

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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description:
The objective outcomes assessor did not know whether the participants were in the intervention or control group.
Primary Purpose: Supportive Care
Transfer Impairment
  • Behavioral: 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.
    Other Name: In-home Training and Provision of AT (prn)
  • Other: 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.
    Other Name: Delayed In-home Training and Provision of AT (prn)
  • Experimental: 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.

    Intervention: Behavioral: Immediate Intervention Group
  • 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: Other: Delayed Intervention Control Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
180
June 2016
June 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02021565
D7873-R
00050313 ( Other Identifier: Emory IRB )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Patricia C Griffiths, PhD Atlanta VA Medical and Rehab Center, Decatur, GA
VA Office of Research and Development
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP