Trial Outcomes & Findings for Evaluating the CG ASSIST Program for Caregiving Dyads (NCT NCT02021565)

NCT ID: NCT02021565

Last Updated: 2018-03-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

126 participants

Primary outcome timeframe

T1 Baseline and T2 Post Intervention; 4-6 Weeks

Results posted on

2018-03-01

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Immediate Intervention Group Receives the in-home training intervention in-person immediately after completing the baseline assessment. In-home Training and Provision of Assistive Technology (prn): Assistive Technology (AT) Specialists, experts on AT 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 AT 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 Group Receives the in-home training intervention in-person 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 (AT) (prn): AT Specialists, experts on AT 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 AT 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.
Baseline Through Intervention STARTED	72	54
Baseline Through Intervention Caregivers	36	27
Baseline Through Intervention Care Recipients	36	27
Baseline Through Intervention COMPLETED	60	36
Baseline Through Intervention NOT COMPLETED	12	18
3-month Follow-up STARTED	60	36
3-month Follow-up Caregivers	30	18
3-month Follow-up Care Recipients	30	18
3-month Follow-up COMPLETED	50	34
3-month Follow-up NOT COMPLETED	10	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Immediate Intervention Group Receives the in-home training intervention in-person immediately after completing the baseline assessment. In-home Training and Provision of Assistive Technology (prn): Assistive Technology (AT) Specialists, experts on AT 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 AT 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 Group Receives the in-home training intervention in-person 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 (AT) (prn): AT Specialists, experts on AT 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 AT 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.
Baseline Through Intervention Death	0	1
Baseline Through Intervention Withdrawal by Subject	8	8
Baseline Through Intervention Protocol Violation	0	7
Baseline Through Intervention Lost to Follow-up	4	2
3-month Follow-up Death	3	0
3-month Follow-up Withdrawal by Subject	4	0
3-month Follow-up Protocol Violation	3	2

Baseline Characteristics

The overall number of baseline participants differs from the number of analyzed participants because this study involved dyads (couples/pairs). Immediate Intervention group=36 dyads (36 caregivers + 36 care recipients = 72 participants). Delayed Intervention Control group=27 dyads(27 caregivers + 27 care recipients = 54 participants).

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Delayed Intervention Control Group n=23 Participants 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.	Immediate Intervention Group n=34 Participants 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.
Caregiver Transfer Efficacy Task Efficacy with Assistance from Caregiver T1	79.57 units on a scale Standard Deviation 21.46	76.41 units on a scale Standard Deviation 25.06
Caregiver Transfer Efficacy Task Efficacy With Assistance from Caregiver T2	67.17 units on a scale Standard Deviation 35.71	64.44 units on a scale Standard Deviation 33.53
Caregiver Transfer Efficacy Task Efficacy Independently T1	41.91 units on a scale Standard Deviation 24.14	45.00 units on a scale Standard Deviation 24.78
Caregiver Transfer Efficacy Task Efficacy Independently T2	32.87 units on a scale Standard Deviation 25.03	44.69 units on a scale Standard Deviation 28.25

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Delayed Intervention Control Group n=27 Participants 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.	Immediate Intervention Group n=35 Participants 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.
Veteran Task Efficacy Task Efficacy With Assistance from Caregiver T1	79.13 units on a scale Standard Deviation 8.31	85.73 units on a scale Standard Deviation 6.06
Veteran Task Efficacy Task Efficacy With Assistance from Caregiver T2	83.75 units on a scale Standard Deviation 6.65	85.53 units on a scale Standard Deviation 4.85
Veteran Task Efficacy Task Efficacy Independent T1	58.37 units on a scale Standard Deviation 24.17	62.60 units on a scale Standard Deviation 12.65
Veteran Task Efficacy Task Efficacy Independent T2	70.50 units on a scale Standard Deviation 14.89	74.06 units on a scale Standard Deviation 13.85

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Delayed Intervention Control Group n=20 Participants 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.	Immediate Intervention Group n=26 Participants 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.
Caregiver Burden Caregiver Burden T1	29.14 units on Zarit Burden scale Standard Deviation 12.28	28.06 units on Zarit Burden scale Standard Deviation 14.31
Caregiver Burden Caregiver Burden T2	27.14 units on Zarit Burden scale Standard Deviation 11.65	26.00 units on Zarit Burden scale Standard Deviation 12.45

Adverse Events

Immediate Intervention Group - In-person

Serious events: 7 serious events

Other events: 0 other events

Deaths: 3 deaths

Delayed Intervention Control Group - In-person

Serious events: 9 serious events

Other events: 0 other events

Deaths: 1 deaths

Immediate Intervention Group - Tele Arm

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed Intervention Control Group - Tele Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Immediate Intervention Group - In-person n=38 participants at risk Receives the in-home training intervention in-person immediately after completing the baseline assessment. In-home Training and Provision of Assistive Technology (AT) (prn): AT Specialists, experts on AT 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 AT 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 Group - In-person n=30 participants at risk Receives the in-home training intervention in-person 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 (AT) (prn): AT Specialists, experts on AT 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 AT 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.	Immediate Intervention Group - Tele Arm n=34 participants at risk Receives the in-home training intervention remotely via a tele-video conference immediately after completing the baseline assessment. In-home Training and Provision of Assistive Technology (AT) (prn): AT Specialists, experts on AT 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 AT 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 Group - Tele Arm n=24 participants at risk Receives the in-home training intervention remotely via a tele-video conference 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 (AT) (prn): AT Specialists, experts on AT 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 AT 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.
General disorders Hospitalization	13.2% 5/38 • Number of events 6 • Information on adverse events was collected for the duration of the study--2.5 years--from December 2013 until the study ended in June 2016. Because care recipients were required to receive assistance with at least one transfer, the majority of care recipient participants were frail. Each serious event reported to the team was recorded and reviewed. Only two potential injury adverse events were determined to be related to the research study because the events involved equipment provided during the intervention. All deaths and hospitalizations were determined to be anticipated due to the frail population and unrelated to the study.	23.3% 7/30 • Number of events 7 • Information on adverse events was collected for the duration of the study--2.5 years--from December 2013 until the study ended in June 2016. Because care recipients were required to receive assistance with at least one transfer, the majority of care recipient participants were frail. Each serious event reported to the team was recorded and reviewed. Only two potential injury adverse events were determined to be related to the research study because the events involved equipment provided during the intervention. All deaths and hospitalizations were determined to be anticipated due to the frail population and unrelated to the study.	8.8% 3/34 • Number of events 3 • Information on adverse events was collected for the duration of the study--2.5 years--from December 2013 until the study ended in June 2016. Because care recipients were required to receive assistance with at least one transfer, the majority of care recipient participants were frail. Each serious event reported to the team was recorded and reviewed. Only two potential injury adverse events were determined to be related to the research study because the events involved equipment provided during the intervention. All deaths and hospitalizations were determined to be anticipated due to the frail population and unrelated to the study.	0.00% 0/24 • Information on adverse events was collected for the duration of the study--2.5 years--from December 2013 until the study ended in June 2016. Because care recipients were required to receive assistance with at least one transfer, the majority of care recipient participants were frail. Each serious event reported to the team was recorded and reviewed. Only two potential injury adverse events were determined to be related to the research study because the events involved equipment provided during the intervention. All deaths and hospitalizations were determined to be anticipated due to the frail population and unrelated to the study.
General disorders Potential for Injury	2.6% 1/38 • Number of events 1 • Information on adverse events was collected for the duration of the study--2.5 years--from December 2013 until the study ended in June 2016. Because care recipients were required to receive assistance with at least one transfer, the majority of care recipient participants were frail. Each serious event reported to the team was recorded and reviewed. Only two potential injury adverse events were determined to be related to the research study because the events involved equipment provided during the intervention. All deaths and hospitalizations were determined to be anticipated due to the frail population and unrelated to the study.	3.3% 1/30 • Number of events 1 • Information on adverse events was collected for the duration of the study--2.5 years--from December 2013 until the study ended in June 2016. Because care recipients were required to receive assistance with at least one transfer, the majority of care recipient participants were frail. Each serious event reported to the team was recorded and reviewed. Only two potential injury adverse events were determined to be related to the research study because the events involved equipment provided during the intervention. All deaths and hospitalizations were determined to be anticipated due to the frail population and unrelated to the study.	0.00% 0/34 • Information on adverse events was collected for the duration of the study--2.5 years--from December 2013 until the study ended in June 2016. Because care recipients were required to receive assistance with at least one transfer, the majority of care recipient participants were frail. Each serious event reported to the team was recorded and reviewed. Only two potential injury adverse events were determined to be related to the research study because the events involved equipment provided during the intervention. All deaths and hospitalizations were determined to be anticipated due to the frail population and unrelated to the study.	0.00% 0/24 • Information on adverse events was collected for the duration of the study--2.5 years--from December 2013 until the study ended in June 2016. Because care recipients were required to receive assistance with at least one transfer, the majority of care recipient participants were frail. Each serious event reported to the team was recorded and reviewed. Only two potential injury adverse events were determined to be related to the research study because the events involved equipment provided during the intervention. All deaths and hospitalizations were determined to be anticipated due to the frail population and unrelated to the study.
General disorders Death	7.9% 3/38 • Number of events 3 • Information on adverse events was collected for the duration of the study--2.5 years--from December 2013 until the study ended in June 2016. Because care recipients were required to receive assistance with at least one transfer, the majority of care recipient participants were frail. Each serious event reported to the team was recorded and reviewed. Only two potential injury adverse events were determined to be related to the research study because the events involved equipment provided during the intervention. All deaths and hospitalizations were determined to be anticipated due to the frail population and unrelated to the study.	3.3% 1/30 • Number of events 1 • Information on adverse events was collected for the duration of the study--2.5 years--from December 2013 until the study ended in June 2016. Because care recipients were required to receive assistance with at least one transfer, the majority of care recipient participants were frail. Each serious event reported to the team was recorded and reviewed. Only two potential injury adverse events were determined to be related to the research study because the events involved equipment provided during the intervention. All deaths and hospitalizations were determined to be anticipated due to the frail population and unrelated to the study.	0.00% 0/34 • Information on adverse events was collected for the duration of the study--2.5 years--from December 2013 until the study ended in June 2016. Because care recipients were required to receive assistance with at least one transfer, the majority of care recipient participants were frail. Each serious event reported to the team was recorded and reviewed. Only two potential injury adverse events were determined to be related to the research study because the events involved equipment provided during the intervention. All deaths and hospitalizations were determined to be anticipated due to the frail population and unrelated to the study.	0.00% 0/24 • Information on adverse events was collected for the duration of the study--2.5 years--from December 2013 until the study ended in June 2016. Because care recipients were required to receive assistance with at least one transfer, the majority of care recipient participants were frail. Each serious event reported to the team was recorded and reviewed. Only two potential injury adverse events were determined to be related to the research study because the events involved equipment provided during the intervention. All deaths and hospitalizations were determined to be anticipated due to the frail population and unrelated to the study.

Other adverse events

Adverse event data not reported

Additional Information

Patricia C. Griffiths

Atlanta VA Medical Center

Phone: 404-321-6111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place