Transfer ImpairmentCG ASSISTNCT02021565
Evaluating the CG ASSIST Program for Caregiving Dyads
A study testing Immediate Intervention Group in people with Transfer Impairment, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transfer Impairment
- What is being tested?
- Immediate Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Caregivers who have a positive screen with the Mini-Cog fail to demonstrate cognitive capacity to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
About this study
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.
Read the 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
- Being tested
- Immediate Intervention Group, Delayed Intervention Control Group
- Keywords
- Caregivers, Activities of Daily Living, Dementia, Veterans, Self-Help Devices, Telemedicine
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Intervention GroupBehavioural
Also called In-home Training and Provision of AT (prn)
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 GroupOther
Also called Delayed In-home Training and Provision of AT (prn)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Delayed Intervention Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T1 Baseline and T2 Post Intervention; 4-6 Weeks
Secondary outcomes (2)
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.
Measured: T1 baseline and T2 Post Intervention; 4-6 weeks
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.
Measured: T1 Baseline and T2 Post Intervention; 4-6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Transfer ImpairmentStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Patricia C Griffiths, PhD, Principal investigator, Atlanta VA Medical and Rehab Center, Decatur, GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021565
- Sponsor's protocol ID
- D7873-R
- Other IDs
- 00050313
- Acronym
- CG ASSIST
- Status last verified
- Feb 2018
- First submitted
- 12 Dec 2013
- Last updated
- 1 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the CG ASSIST Program for Caregiving Dyads
- ClinicalTrials.gov ID
- NCT02021565
- Acronym / sponsor ID
- CG ASSIST / D7873-R
- Conditions
- Transfer Impairment
- Keywords
- Caregivers, Activities of Daily Living, Dementia, Veterans, Self-Help Devices, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Dec 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Posted 1 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention Group | Experimental | Behavioral: Immediate Intervention GroupReceives 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. |
| Delayed Intervention Control Group | Other | Other: Delayed Intervention Control GroupReceives 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (1 listed)
- Caregivers who have a positive screen with the Mini-Cog fail to demonstrate cognitive capacity to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate Intervention GroupAlso: In-home Training and Provision of AT (prn)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. | Behavioural | Immediate Intervention Group |
| Delayed Intervention Control GroupAlso: Delayed In-home Training and Provision of AT (prn)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 |
Primary outcome
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.
2 secondary outcomes
Veteran Task Efficacy
Time frame: T1 baseline and T2 Post Intervention; 4-6 weeks
Caregiver Burden
Time frame: T1 Baseline and T2 Post Intervention; 4-6 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia C Griffiths, PhD principal investigator
Atlanta VA Medical and Rehab Center, Decatur, GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Intervention Group in people with Transfer Impairment, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Transfer Efficacy (time frame: T1 Baseline and T2 Post Intervention; 4-6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.