Trial Outcomes & Findings for CAPABLE Transitions: A Home Health-Based Intervention for the Hospital or Post-Acute Care Facility-to-Home Transition (NCT NCT04460742)
NCT ID: NCT04460742
Last Updated: 2023-08-01
Results Overview
The study will monitor how many older adults are screened and satisfy the eligibility criteria.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
For each potential participant, this outcome is determined prior to possible study enrollment.
Results posted on
2023-08-01
Participant Flow
Participant milestones
| Measure |
CAPABLE Transitions
Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (\<6 visits), registered nurse (\<5 visits), and handyman (\<2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
Care As Usual
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CAPABLE Transitions: A Home Health-Based Intervention for the Hospital or Post-Acute Care Facility-to-Home Transition
Baseline characteristics by cohort
| Measure |
CAPABLE Transitions
n=16 Participants
Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (\<6 visits), registered nurse (\<5 visits), and handyman (\<2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
Care As Usual
n=15 Participants
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77 Years
STANDARD_DEVIATION 6.66 • n=99 Participants
|
71.8 Years
STANDARD_DEVIATION 6.33 • n=107 Participants
|
74.5 Years
STANDARD_DEVIATION 6.92 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: For each potential participant, this outcome is determined prior to possible study enrollment.The study will monitor how many older adults are screened and satisfy the eligibility criteria.
Outcome measures
| Measure |
Overall Study Screening and Recruitment
n=311 Participants
This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.
|
Care As Usual
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Percentage of Participants Screened as Eligible
|
180 Participants
|
—
|
PRIMARY outcome
Timeframe: This outcome is determined at the time of study enrollment.The study will monitor how many older adults who satisfy the eligibility criteria are enrolled in the study.
Outcome measures
| Measure |
Overall Study Screening and Recruitment
n=180 Participants
This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.
|
Care As Usual
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Percentage of Screened Participants That Enroll
|
31 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 monthsThe study will monitor the percentage of participants that complete the study.
Outcome measures
| Measure |
Overall Study Screening and Recruitment
n=16 Participants
This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.
|
Care As Usual
n=15 Participants
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Percentage of Enrolled Participants That Are Retained
|
14 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: 3 monthsParticipants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.
Outcome measures
| Measure |
Overall Study Screening and Recruitment
n=14 Participants
This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.
|
Care As Usual
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Percentage of Participants Who Perceive a Benefit From the Intervention
|
13 Participants
|
—
|
PRIMARY outcome
Timeframe: 6 monthsParticipants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.
Outcome measures
| Measure |
Overall Study Screening and Recruitment
n=13 Participants
This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.
|
Care As Usual
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Percentage of Participants Who Perceive a Benefit From the Intervention
|
12 Participants
|
—
|
PRIMARY outcome
Timeframe: Throughout Study Intervention, an average of 5 monthsThe study will review audio recordings and study interventionists' documentation to examine fidelity to the intervention and score whether the interventionists completed the central tasks of CAPABLE Transitions. The study will score completion of the critical components as "yes" or "no" and this outcome will be reported as the proportion of critical components of the CAPABLE Transitions intervention that were completed by the occupational therapist and registered nurse.
Outcome measures
| Measure |
Overall Study Screening and Recruitment
n=40 Critical Tasks
This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.
|
Care As Usual
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Proportion of Critical Tasks Completed
|
0.89 Proportion of Critical Tasks Completed
Standard Deviation 0.08
|
—
|
PRIMARY outcome
Timeframe: 3 monthsThe study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 3 months.
Outcome measures
| Measure |
Overall Study Screening and Recruitment
n=16 Participants
This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.
|
Care As Usual
n=15 Participants
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Data Completeness on Clinical Outcomes
|
16 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 6 months.
Outcome measures
| Measure |
Overall Study Screening and Recruitment
n=16 Participants
This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.
|
Care As Usual
n=15 Participants
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Data Completeness on Clinical Outcomes
|
14 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 3 (3 months)Home time is the number of days participants spend alive in non-institutional settings (e.g., nursing homes and hospitals). The study will report the participants' home time from baseline to 3 months of follow-up.
Outcome measures
| Measure |
Overall Study Screening and Recruitment
n=16 Participants
This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.
|
Care As Usual
n=15 Participants
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Home Time in Days (From the Baseline to 3 Month Period)
|
87.94 days
Standard Deviation 7.25
|
88.67 days
Standard Deviation 3.99
|
SECONDARY outcome
Timeframe: Month 3 to Month 6 (3 months)Home time is the number of days participants spend alive in non-institutional settings (e.g., nursing homes and hospitals). The study will report the participants' home time from 3 to 6 months of follow-up.
Outcome measures
| Measure |
Overall Study Screening and Recruitment
n=16 Participants
This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.
|
Care As Usual
n=14 Participants
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Home Time in Days (From the 3 to 6 Month Period)
|
89.38 days
Standard Deviation 2.00
|
89.86 days
Standard Deviation 0.36
|
SECONDARY outcome
Timeframe: 3 monthsThe study will examine quality of life (EQ-5D-5L) among study participants at 3 months of follow-up (positive scores indicate improvement from baseline). Rating: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 1 as lowest score and 5 as highest score: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate worse outcome. The EQ VAS question records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (score=100) and 'The worst health you can imagine' (score=0). Therefore higher scores may indicate better outcomes.
Outcome measures
| Measure |
Overall Study Screening and Recruitment
n=15 Participants
This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.
|
Care As Usual
n=14 Participants
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
Mobility Change
|
0.73 score on a scale
Standard Deviation 1.33
|
1.07 score on a scale
Standard Deviation 1.07
|
|
Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
Self-Care Change
|
0.40 score on a scale
Standard Deviation 0.74
|
0.50 score on a scale
Standard Deviation 0.76
|
|
Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
Usual Activities Change
|
0.73 score on a scale
Standard Deviation 1.39
|
0.79 score on a scale
Standard Deviation 1.05
|
|
Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
Pain/Discomfort Change
|
-0.07 score on a scale
Standard Deviation 0.96
|
0.36 score on a scale
Standard Deviation 1.50
|
|
Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
Anxiety/Depression Change
|
-0.13 score on a scale
Standard Deviation 0.64
|
0.14 score on a scale
Standard Deviation 0.77
|
|
Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
Self-Rated Health Change
|
6.27 score on a scale
Standard Deviation 28.29
|
1.43 score on a scale
Standard Deviation 15.80
|
SECONDARY outcome
Timeframe: 6 monthsThe study will examine quality of life (EQ-5D-5L) among study participants at 6 months of follow-up (positive scores indicate improvement from baseline). Rating: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 1 as lowest score and 5 as highest score: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate worse outcome. The EQ VAS question records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (score=100) and 'The worst health you can imagine' (score=0). Therefore higher scores may indicate better outcomes.
Outcome measures
| Measure |
Overall Study Screening and Recruitment
n=14 Participants
This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.
|
Care As Usual
n=14 Participants
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
Mobility Change
|
0.57 score on a scale
Standard Deviation 1.09
|
0.71 score on a scale
Standard Deviation 1.07
|
|
Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
Self-Care Change
|
0.50 score on a scale
Standard Deviation 0.94
|
0.36 score on a scale
Standard Deviation 0.93
|
|
Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
Usual Activities Change
|
1.21 score on a scale
Standard Deviation 1.19
|
0.93 score on a scale
Standard Deviation 1.07
|
|
Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
Pain/Discomfort Change
|
0.29 score on a scale
Standard Deviation 1.07
|
0.50 score on a scale
Standard Deviation 1.40
|
|
Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
Anxiety/Depression Change
|
-0.36 score on a scale
Standard Deviation 1.01
|
-0.29 score on a scale
Standard Deviation 0.73
|
|
Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
Self-Rated Health Change
|
8.07 score on a scale
Standard Deviation 26.83
|
10.5 score on a scale
Standard Deviation 12.91
|
SECONDARY outcome
Timeframe: Baseline to Month 3 (3 months)The study will examine the percentage of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from baseline to 3 months of follow-up.
Outcome measures
| Measure |
Overall Study Screening and Recruitment
n=16 Participants
This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.
|
Care As Usual
n=15 Participants
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Health Services Use, Percentage
ED Visit
|
1 Participants
|
1 Participants
|
|
Health Services Use, Percentage
Hospitalization
|
2 Participants
|
2 Participants
|
|
Health Services Use, Percentage
Skilled Nursing Facility Admission
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 3 to Month 6 (3 months)The study will examine the percentage of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from 3 to 6 months of follow-up.
Outcome measures
| Measure |
Overall Study Screening and Recruitment
n=16 Participants
This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.
|
Care As Usual
n=14 Participants
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Health Services Use, Percentage
Hospitalization
|
2 Participants
|
0 Participants
|
|
Health Services Use, Percentage
Skilled Nursing Facility Admission
|
0 Participants
|
0 Participants
|
|
Health Services Use, Percentage
ED Visit
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 3 (3 months)The study will tabulate the mean number of times participants went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from baseline to 3 months of follow-up.
Outcome measures
| Measure |
Overall Study Screening and Recruitment
n=16 Participants
This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.
|
Care As Usual
n=15 Participants
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Health Services Use, Mean
ED Visit
|
0.06 events
Standard Deviation 0.25
|
0.07 events
Standard Deviation 0.26
|
|
Health Services Use, Mean
Hospitalization
|
0.13 events
Standard Deviation 0.34
|
0.27 events
Standard Deviation 0.70
|
|
Health Services Use, Mean
Skilled Nursing Facility Admission
|
0 events
Standard Deviation 0
|
0 events
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Month 3 to Month 6 (3 months)The study will tabulate the mean number of times participants went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from 3 to 6 months of follow-up.
Outcome measures
| Measure |
Overall Study Screening and Recruitment
n=16 Participants
This section refers to all of the people screened and ultimately recruited into the study, prior to randomization to different treatment arms.
|
Care As Usual
n=14 Participants
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Health Services Use, Mean
ED Visit
|
0.19 events
Standard Deviation 0.40
|
0.14 events
Standard Deviation 0.73
|
|
Health Services Use, Mean
Hospitalization
|
0.13 events
Standard Deviation 0.34
|
0 events
Standard Deviation 0
|
|
Health Services Use, Mean
Skilled Nursing Facility Admission
|
0 events
Standard Deviation 0
|
0 events
Standard Deviation 0
|
Adverse Events
CAPABLE Transitions
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Care As Usual
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAPABLE Transitions
n=16 participants at risk
Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (\<6 visits), registered nurse (\<5 visits), and handyman (\<2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
Care As Usual
n=15 participants at risk
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle cramping or swelling
|
6.2%
1/16 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
6.7%
1/15 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
|
Gastrointestinal disorders
Abdominal pain and discomfort
|
12.5%
2/16 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
6.7%
1/15 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
|
Musculoskeletal and connective tissue disorders
Fall with injury
|
6.2%
1/16 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
0.00%
0/15 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
|
Infections and infestations
Joint infection
|
6.2%
1/16 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
0.00%
0/15 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
6.2%
1/16 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
0.00%
0/15 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
|
Psychiatric disorders
Substance intoxication
|
6.2%
1/16 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
0.00%
0/15 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
Other adverse events
| Measure |
CAPABLE Transitions
n=16 participants at risk
Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months.
CAPABLE Transitions: The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (\<6 visits), registered nurse (\<5 visits), and handyman (\<2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
Care As Usual
n=15 participants at risk
Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual.
Home Health Agency Care: Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
|
|---|---|---|
|
Metabolism and nutrition disorders
Fall
|
0.00%
0/16 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
6.7%
1/15 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
|
Musculoskeletal and connective tissue disorders
Minor back fracture
|
6.2%
1/16 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
0.00%
0/15 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
|
Infections and infestations
COVID-19 Exposure
|
12.5%
2/16 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
0.00%
0/15 • From study recruitment to termination of data collection, an average of 6 months.
At every study visit, study interventionists and research coordinators asked about any medical events that occurred since the prior visit. We also reviewed the participants' medical charts at 3 and 6 months, which provided information about medical events. Of note, none of the serious adverse events were believed to be study related.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place