Transfer Impairment
Conditions
Keywords
Caregivers, Activities of Daily Living, Dementia, Veterans, Self-Help Devices, Telemedicine
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.
Interventions
BEHAVIORALImmediate 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.
OTHERDelayed 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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
The objective outcomes assessor did not know whether the participants were in the intervention or control group.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Transfer Efficacy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Veteran Task Efficacy | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment began in December 2013 and ended June 2016. Potential Veterans and informal/family caregivers were identified through the Department of Veterans Affairs Corporate Data Warehouse. The study was also advertised at community events and in local newspapers.
Participants by arm
| Arm | Count |
|---|---|
| Immediate Intervention Group Receives the in-home training intervention immediately after completing the baseline assessment.
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. | 72 |
| 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.
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. | 54 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3-month Follow-up | Death | 3 | 0 |
| 3-month Follow-up | Protocol Violation | 3 | 2 |
| 3-month Follow-up | Withdrawal by Subject | 4 | 0 |
| Baseline Through Intervention | Death | 0 | 1 |
| Baseline Through Intervention | Lost to Follow-up | 4 | 2 |
| Baseline Through Intervention | Protocol Violation | 0 | 7 |
| Baseline Through Intervention | Withdrawal by Subject | 8 | 8 |
Baseline characteristics
| Characteristic | Total | Delayed Intervention Control Group | Immediate Intervention Group |
|---|---|---|---|
| Age, Customized Caregiver Age | 66 years STANDARD_DEVIATION 9.4 | 66 years STANDARD_DEVIATION 9.1 | 66 years STANDARD_DEVIATION 9.5 |
| Age, Customized Care Recipient Age | 75.5 years STANDARD_DEVIATION 9.8 | 77.2 years STANDARD_DEVIATION 9.3 | 74.3 years STANDARD_DEVIATION 10.1 |
| Caregiver Relationship to Veteran Daughter | 6 Participants | 3 Participants | 3 Participants |
| Caregiver Relationship to Veteran Mother | 1 Participants | 0 Participants | 1 Participants |
| Caregiver Relationship to Veteran Neice | 1 Participants | 1 Participants | 0 Participants |
| Caregiver Relationship to Veteran Sister | 2 Participants | 1 Participants | 1 Participants |
| Caregiver Relationship to Veteran Spouse | 49 Participants | 20 Participants | 29 Participants |
| Care Recipient Total Diagnoses | 20.83 Health Problems STANDARD_DEVIATION 11.12 | 23.33 Health Problems STANDARD_DEVIATION 12.17 | 18.94 Health Problems STANDARD_DEVIATION 9.86 |
| Education Caregivers | 40 Participants | 18 Participants | 22 Participants |
| Education Care Recipients | 38 Participants | 17 Participants | 21 Participants |
| Employment Caregivers Employed | 6 Participants | 3 Participants | 3 Participants |
| Employment Caregivers Not Employed | 19 Participants | 8 Participants | 11 Participants |
| Employment Caregivers Retired | 34 Participants | 14 Participants | 20 Participants |
| Employment Care Recipients Employed | 26 Participants | 12 Participants | 14 Participants |
| Employment Care Recipients Not Employed | 13 Participants | 7 Participants | 6 Participants |
| Employment Care Recipients Retired | 15 Participants | 3 Participants | 12 Participants |
| Health Status Caregivers Excellent | 6 Participants | 4 Participants | 2 Participants |
| Health Status Caregivers Fair | 4 Participants | 2 Participants | 2 Participants |
| Health Status Caregivers Good | 27 Participants | 6 Participants | 21 Participants |
| Health Status Caregivers Poor | 1 Participants | 1 Participants | 0 Participants |
| Health Status Caregivers Very Good | 19 Participants | 10 Participants | 9 Participants |
| Health Status Care Recipients Excellent | 0 Participants | 0 Participants | 0 Participants |
| Health Status Care Recipients Fair | 9 Participants | 5 Participants | 4 Participants |
| Health Status Care Recipients Good | 10 Participants | 0 Participants | 10 Participants |
| Health Status Care Recipients Poor | 3 Participants | 2 Participants | 1 Participants |
| Health Status Care Recipients Very Good | 2 Participants | 1 Participants | 1 Participants |
| Income | 21 Participants | 10 Participants | 11 Participants |
| Marital Status | 53 Participants | 21 Participants | 32 Participants |
| Military Branch Air Force | 13 Participants | 5 Participants | 8 Participants |
| Military Branch Army | 29 Participants | 13 Participants | 16 Participants |
| Military Branch Coast Guard | 1 Participants | 1 Participants | 0 Participants |
| Military Branch Marines | 5 Participants | 2 Participants | 3 Participants |
| Military Branch Navy | 7 Participants | 2 Participants | 5 Participants |
| Number of CG Health Problems | 2.37 Health problems STANDARD_DEVIATION 1.78 | 2.24 Health problems STANDARD_DEVIATION 1.63 | 2.47 Health problems STANDARD_DEVIATION 1.88 |
| Race (NIH/OMB) Caregiver American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Caregiver Black or African American | 33 Participants | 13 Participants | 20 Participants |
| Race (NIH/OMB) Caregiver More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver White | 23 Participants | 10 Participants | 13 Participants |
| Race (NIH/OMB) Care Recipient American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Care Recipient Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Care Recipient Black or African American | 29 Participants | 10 Participants | 19 Participants |
| Race (NIH/OMB) Care Recipient More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Care Recipient Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Care Recipient Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Care Recipient White | 24 Participants | 11 Participants | 13 Participants |
| Region of Enrollment United States | 126 Participants | 54 Participants | 72 Participants |
| Sex/Gender, Customized Female Caregivers | 56 Participants | 22 Participants | 34 Participants |
| Sex/Gender, Customized Male Veterans | 61 Participants | 27 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 38 | 1 / 30 | 0 / 34 | 0 / 24 |
| other Total, other adverse events | 0 / 38 | 0 / 30 | 0 / 34 | 0 / 24 |
| serious Total, serious adverse events | 7 / 38 | 9 / 30 | 3 / 34 | 0 / 24 |
Outcome results
Primary
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.
Time frame: T1 Baseline and T2 Post Intervention; 4-6 Weeks
Population: Caregivers who reported their Veteran care recipient performed transfer tasks with assistance from informal caregiver. Two caregivers from the Intervention group and four caregivers from the Control group did not complete T2 and their data was not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Group | Caregiver Transfer Efficacy | Task Efficacy with Assistance from Caregiver T1 | 76.41 units on a scale | Standard Deviation 25.06 |
| Immediate Intervention Group | Caregiver Transfer Efficacy | Task Efficacy Independently T2 | 44.69 units on a scale | Standard Deviation 28.25 |
| Immediate Intervention Group | Caregiver Transfer Efficacy | Task Efficacy With Assistance from Caregiver T2 | 64.44 units on a scale | Standard Deviation 33.53 |
| Immediate Intervention Group | Caregiver Transfer Efficacy | Task Efficacy Independently T1 | 45.00 units on a scale | Standard Deviation 24.78 |
| Delayed Intervention Control Group | Caregiver Transfer Efficacy | Task Efficacy with Assistance from Caregiver T1 | 79.57 units on a scale | Standard Deviation 21.46 |
| Delayed Intervention Control Group | Caregiver Transfer Efficacy | Task Efficacy Independently T1 | 41.91 units on a scale | Standard Deviation 24.14 |
| Delayed Intervention Control Group | Caregiver Transfer Efficacy | Task Efficacy With Assistance from Caregiver T2 | 67.17 units on a scale | Standard Deviation 35.71 |
| Delayed Intervention Control Group | Caregiver Transfer Efficacy | Task Efficacy Independently T2 | 32.87 units on a scale | Standard Deviation 25.03 |
Comparison: Analysis 1 is for the caregiver reported confidence that Veteran care recipient can perform 10 transfer tasks with assistance from the informal caregiver.p-value: 0.973ANOVA
Comparison: Analysis 2 is for the caregiver reported confidence that Veteran care recipient can perform 10 transfer tasks independently.p-value: 0.223ANOVA
Secondary
Caregiver Burden
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.
Time frame: T1 Baseline and T2 Post Intervention; 4-6 Weeks
Population: Composite caregiver burden reported by informal caregiver. Ten caregivers from the Intervention group and seven caregivers from the Control group did not complete T2 and their data was not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Group | Caregiver Burden | Caregiver Burden T2 | 26.00 units on Zarit Burden scale | Standard Deviation 12.45 |
| Immediate Intervention Group | Caregiver Burden | Caregiver Burden T1 | 28.06 units on Zarit Burden scale | Standard Deviation 14.31 |
| Delayed Intervention Control Group | Caregiver Burden | Caregiver Burden T2 | 27.14 units on Zarit Burden scale | Standard Deviation 11.65 |
| Delayed Intervention Control Group | Caregiver Burden | Caregiver Burden T1 | 29.14 units on Zarit Burden scale | Standard Deviation 12.28 |
p-value: 0.729ANOVA
Secondary
Veteran Task Efficacy
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.
Time frame: T1 baseline and T2 Post Intervention; 4-6 weeks
Population: Veteran care recipient reported efficacy in performing transfer tasks with assistance from informal caregiver and independently. One Veteran from the Intervention group did not complete T2 and their data were not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Immediate Intervention Group | Veteran Task Efficacy | Task Efficacy With Assistance from Caregiver T1 | 85.73 units on a scale | Standard Deviation 6.06 |
| Immediate Intervention Group | Veteran Task Efficacy | Task Efficacy With Assistance from Caregiver T2 | 85.53 units on a scale | Standard Deviation 4.85 |
| Immediate Intervention Group | Veteran Task Efficacy | Task Efficacy Independent T1 | 62.60 units on a scale | Standard Deviation 12.65 |
| Immediate Intervention Group | Veteran Task Efficacy | Task Efficacy Independent T2 | 74.06 units on a scale | Standard Deviation 13.85 |
| Delayed Intervention Control Group | Veteran Task Efficacy | Task Efficacy Independent T2 | 70.50 units on a scale | Standard Deviation 14.89 |
| Delayed Intervention Control Group | Veteran Task Efficacy | Task Efficacy With Assistance from Caregiver T1 | 79.13 units on a scale | Standard Deviation 8.31 |
| Delayed Intervention Control Group | Veteran Task Efficacy | Task Efficacy Independent T1 | 58.37 units on a scale | Standard Deviation 24.17 |
| Delayed Intervention Control Group | Veteran Task Efficacy | Task Efficacy With Assistance from Caregiver T2 | 83.75 units on a scale | Standard Deviation 6.65 |
Comparison: Analysis 1 is for the Veteran care recipient reported task efficacyp-value: 0.547ANOVA
Comparison: Analysis 2 is for the Veteran reported confidence that he/she can perform 10 transfer tasks independently.p-value: 0.891ANOVA