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Trial record 22 of 5441 for:    veterans

Helping Invested Families Improve Veterans Experiences Study (HI-FIVES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01777490
Recruitment Status : Completed
First Posted : January 28, 2013
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Caregiver
Disabled Veterans
Referred to Long-term Care
Residing at Home
Hospice Ineligible
Interventions Behavioral: Helping Invested Families Improve Veterans Experiences - Control
Behavioral: Helping Invested Families Improve Veterans Experiences - HI FIVES
Enrollment 484
Recruitment Details  
Pre-assignment Details Patient's and their informal caregiver are randomized as a dyad to a single arm assignment, either HI-FIVES or Control.
Arm/Group Title Arm 1: Control - Caregivers Arm 1: Control - Patients Arm 2: HI FIVES - Caregivers Arm 2: HI-FIVES - Patients
Hide Arm/Group Description

Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home.

Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. Caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally.

The patient of each informal caregiver was also enrolled with contact limited to assessments.

Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source.

Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions.

Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.

The patient of each informal caregiver was also enrolled with contact limited to assessments.

Helping Invested Families Improve Veterans Experiences Study - HI-FIVES: Patients randomized to the HI-FIVES arm received no direct intervention. All intervention activities focused on the patient's informal caregiver. As with Usual care, patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the HI-FIVES group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source.

Period Title: Overall Study
Started 123 123 119 119
Completed [1] 123 123 118 118
Not Completed 0 0 1 1
Reason Not Completed
Dyad withdrew with data use prohibition             0             0             1             1
[1]
Primary outcome is gathered from medical records. Survey outcomes have lower completion rates.
Arm/Group Title Arm 1: Control - Caregivers Arm 1: Control - Patients Arm 2: HI-FIVES - Caregivers Arm 2: HI FIVES - Patients Total
Hide Arm/Group Description

Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home.

Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. Caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally.

The patient of each informal caregiver was also enrolled with contact limited to assessments.

Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source.

Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions.

Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.

The patient of each informal caregiver was also enrolled with contact limited to assessments.

Helping Invested Families Improve Veterans Experiences Study - HI-FIVES: Patients randomized to the HI-FIVES arm received no direct intervention. All intervention activities focused on the patient's informal caregiver. As with Usual care, patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the HI-FIVES group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source.

Total of all reporting groups
Overall Number of Baseline Participants 123 123 119 119 484
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 123 participants 123 participants 118 participants 118 participants 482 participants
61.8  (12.60) 72.9  (12.12) 59.9  (11.78) 73.7  (11.24) 73.3  (11.68)
[1]
Measure Analysis Population Description: One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 123 participants 118 participants 118 participants 482 participants
Female
111
  90.2%
5
   4.1%
103
  87.3%
4
   3.4%
223
  46.3%
Male
12
   9.8%
118
  95.9%
15
  12.7%
114
  96.6%
259
  53.7%
[1]
Measure Analysis Population Description: One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 123 participants 118 participants 118 participants 482 participants
Hispanic or Latino
4
   3.3%
4
   3.3%
2
   1.7%
1
   0.8%
11
   2.3%
Not Hispanic or Latino
118
  95.9%
117
  95.1%
116
  98.3%
117
  99.2%
468
  97.1%
Unknown or Not Reported
1
   0.8%
2
   1.6%
0
   0.0%
0
   0.0%
3
   0.6%
[1]
Measure Analysis Population Description: One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 123 participants 118 participants 118 participants 482 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
1
   0.2%
Asian
1
   0.8%
1
   0.8%
0
   0.0%
0
   0.0%
2
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   0.8%
0
   0.0%
1
   0.2%
Black or African American
59
  48.0%
60
  48.8%
50
  42.4%
48
  40.7%
217
  45.0%
White
48
  39.0%
48
  39.0%
56
  47.5%
60
  50.8%
212
  44.0%
More than one race
15
  12.2%
13
  10.6%
11
   9.3%
9
   7.6%
48
  10.0%
Unknown or Not Reported
0
   0.0%
1
   0.8%
0
   0.0%
0
   0.0%
1
   0.2%
[1]
Measure Analysis Population Description: One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 123 participants 123 participants 118 participants 118 participants 482 participants
123
 100.0%
123
 100.0%
118
 100.0%
118
 100.0%
482
 100.0%
[1]
Measure Analysis Population Description: One enrolled patient/caregiver dyad in the intervention arm withdrew with an accompanying request to not use any of their data.
1.Primary Outcome
Title Patient Days in the Community (e.g. Days Not in Emergency Department, Inpatient, or Nursing Home Setting)
Hide Description Days at home is defined as the total numbers of days of VA, inpatient and post-acute facility care subtracted from 365 (or number of days living in 12 month post randomization period if deceased). Mean was estimated using a generalized linear model.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled subjects were included in the analysis of the primary outcome, except for the one subject who withdrew permission to use data.
Arm/Group Title Arm 1: Control Arm 2: HI FIVES
Hide Arm/Group Description:

Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home. The patient of each caregiver was also enrolled with contact limited to assessments.

Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source. In addition, caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally.

Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. The patient of each caregiver was also enrolled with contact limited to assessments.

Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.

Overall Number of Participants Analyzed 123 118
Mean (95% Confidence Interval)
Unit of Measure: days
352.87
(348.76 to 355.94)
353.62
(349.75 to 356.51)
2.Secondary Outcome
Title Total Costs to the VA
Hide Description VA utilization costs will be summarized across VA and non-VA contracted care and will capture all outpatient costs (laboratory, radiology, pharmacy, surgery, nursing, and treat and release ED visits) and inpatient costs (similar categories). Mean was estimated using a generalized linear model.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patient subjects were included in the analysis of this outcome, except for the one subject who withdrew permission to use data.
Arm/Group Title Arm 1: Control Arm 2: HI FIVES
Hide Arm/Group Description:

Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home. The patient of each caregiver was also enrolled with contact limited to assessments.

Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source. In addition, caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally.

Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. The patient of each caregiver was also enrolled with contact limited to assessments.

Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.

Overall Number of Participants Analyzed 123 118
Mean (95% Confidence Interval)
Unit of Measure: Dollars
44227.55
(34772.66 to 56253.30)
41157.17
(33455.72 to 50631.47)
3.Secondary Outcome
Title Satisfaction With Healthcare
Hide Description Consumer Assessment of Healthcare Providers and Systems (CAHPS). Used by the VA Office of Performance and Quality, this outcome is considered a key measure of patient satisfaction with inpatient and outpatient care. The investigators will focus on a global satisfaction measure about the health plan: "Using any number from 0 to 10, where 0 is the worst health care possible and 10 is the best health care possible, what number would [PATIENT: you/the patient (if not competent to answer for themselves) use to rate all of your/his/her] [CAREGIVER: you use to rate all the patient's] health care in the VA in the last 3 months?" This measure was asked of both the patient and their informal caregiver. If the patient was not competent to answer for themselves, the caregiver was asked to respond on the patient's behalf. Mean was estimated using a linear mixed model.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
This measure was collected from both the patient (or their proxy if not competent) and their informal caregiver. We had one dyad who withdrew from Arm 2 (HI FIVES) and asked us not to use their data.
Arm/Group Title Arm 1: Control (CAREGIVER) Arm 1: Control (PATIENT) Arm 2: HI FIVES (CAREGIVER) Arm 2: HI FIVES (PATIENT)
Hide Arm/Group Description:

Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home.

Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source. In addition, caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally.

The patient of each caregiver was also enrolled with contact limited to assessments.

Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions.

Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.

The patient of each caregiver was also enrolled with contact limited to assessments.
Overall Number of Participants Analyzed 123 123 118 118
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
8.29
(7.97 to 8.61)
8.09
(7.70 to 8.48)
8.58
(8.25 to 8.89)
8.38
(7.99 to 8.77)
4.Secondary Outcome
Title Caregiver Depressive Symptoms
Hide Description The investigators selected the Center for Epidemiological Studies-Depression 10 scale (CESD-10) measure of depressive symptoms because the respondent burden is low and in order to maximize comparability with REACH I and REACH II. Range is 0-30 with a higher score indicates greater depressive symptoms. Mean was estimated using a linear mixed model.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled caregiver subjects were included in the analysis of this outcome, except for the one dayd who withdrew permission to use data.
Arm/Group Title Arm 1: Control Arm 2: HI FIVES
Hide Arm/Group Description:

Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home. The patient of each caregiver was also enrolled with contact limited to assessments.

Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source. In addition, caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally.

Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions. The patient of each caregiver was also enrolled with contact limited to assessments.

Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.

Overall Number of Participants Analyzed 123 118
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
8.95
(7.90 to 10.00)
8.75
(7.69 to 9.82)
Time Frame Adverse event data were collected from the date of enrollment up to 365 days post-randomization.
Adverse Event Reporting Description We systematically collected adverse event reports for the patient participants as we collected all medical records, both VA and non-VA, for the duration of their enrollment. We collected adverse event reports from the caregivers on a self-reported, non-systematic, basis.
 
Arm/Group Title Arm 1: Control - Caregivers Arm 1: Control - Patients Arm 2: HI-FIVES - Caregivers Arm 2: HI FIVES - Patients
Hide Arm/Group Description

Caregivers in the control arm were referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home.

Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. Caregivers in this arm were told about the caregiver support programs in the VHA and received the national VA caregiver hotline phone number. This mirrors efforts to support caregivers in the VA nationally.

The patient of each informal caregiver was also enrolled with contact limited to assessments.

Helping Invested Families Improve Veterans Experiences Study - Control: Usual care was the Veteran patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the usual care group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source.

Caregivers took part in 3 phone training sessions and attended 4 group training sessions at the VA. They also had 2 post-group booster phone training sessions.

Helping Invested Families Improve Veterans Experiences Study - HI FIVES: Caregivers received 3 individual calls with a nurse educator to address self-identified priority topics. These calls were tailored to the individual needs of Veteran-caregiver dyad. Caregivers then participated in evidence-based group sessions aimed to improve skills in clinical care, psychological care, and support-seeking. The curriculum was delivered by a trained nurse educator, the PI, and VA Caregiver Support staff. The 4 group training sessions were targeted to address common needs of Veterans and their caregivers. After the final group session, there were 2 follow-up booster calls at one and three months to check in with the caregiver.

The patient of each informal caregiver was also enrolled with contact limited to assessments.

Helping Invested Families Improve Veterans Experiences Study - HI-FIVES: Patients randomized to the HI-FIVES arm received no direct intervention. All intervention activities focused on the patient's informal caregiver. As with Usual care, patient care and caregiver support normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This entails the patient and caregiver work with the assigned social worker to obtain home and community based care (HCBC) services. The patients in the HI-FIVES group were free to seek medical, psychological, social support, and social services available through VAMCs or any other source.

All-Cause Mortality
Arm 1: Control - Caregivers Arm 1: Control - Patients Arm 2: HI-FIVES - Caregivers Arm 2: HI FIVES - Patients
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/123 (0.00%)      10/123 (8.13%)      0/118 (0.00%)      14/118 (11.86%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Control - Caregivers Arm 1: Control - Patients Arm 2: HI-FIVES - Caregivers Arm 2: HI FIVES - Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/123 (0.00%)      71/123 (57.72%)      0/118 (0.00%)      68/118 (57.63%)    
Blood and lymphatic system disorders         
Hospitalization *  /123  1/123 (0.81%)  1 /118  3/118 (2.54%)  3
Cardiac disorders         
Death *  /123  0/123 (0.00%)  0 /118  2/118 (1.69%)  2
Hospitalization *  /123  11/123 (8.94%)  15 /118  9/118 (7.63%)  10
Endocrine disorders         
Hospitalization *  /123  3/123 (2.44%)  4 /118  2/118 (1.69%)  2
Gastrointestinal disorders         
Hospitalization *  /123  6/123 (4.88%)  11 /118  3/118 (2.54%)  4
General disorders         
Death *  /123  5/123 (4.07%)  5 /118  3/118 (2.54%)  3
Hospitalization *  /123  10/123 (8.13%)  11 /118  4/118 (3.39%)  5
Infections and infestations         
Hospitalization *  /123  15/123 (12.20%)  20 /118  14/118 (11.86%)  19
Injury, poisoning and procedural complications         
Death *  /123  0/123 (0.00%)  0 /118  1/118 (0.85%)  1
Hospitalization *  /123  12/123 (9.76%)  13 /118  6/118 (5.08%)  7
Metabolism and nutrition disorders         
Hospitalization *  /123  1/123 (0.81%)  1 /118  3/118 (2.54%)  3
Musculoskeletal and connective tissue disorders         
Hospitalization *  /123  4/123 (3.25%)  4 /118  2/118 (1.69%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Death *  /123  2/123 (1.63%)  2 /118  1/118 (0.85%)  1
Hospitalization *  /123  2/123 (1.63%)  2 /118  2/118 (1.69%)  2
Nervous system disorders         
Death *  /123  2/123 (1.63%)  2 /118  3/118 (2.54%)  3
Hospitalization *  /123  10/123 (8.13%)  11 /118  8/118 (6.78%)  8
Renal and urinary disorders         
Death *  /123  0/123 (0.00%)  0 /118  1/118 (0.85%)  1
Hospitalization *  /123  4/123 (3.25%)  5 /118  10/118 (8.47%)  12
Respiratory, thoracic and mediastinal disorders         
Death *  /123  1/123 (0.81%)  1 /118  3/118 (2.54%)  3
Hospitalization *  /123  12/123 (9.76%)  19 /118  12/118 (10.17%)  14
Skin and subcutaneous tissue disorders         
Hospitalization *  /123  1/123 (0.81%)  1 /118  1/118 (0.85%)  1
Surgical and medical procedures         
Hospitalization *  /123  4/123 (3.25%)  5 /118  14/118 (11.86%)  16
Vascular disorders         
Hospitalization *  /123  4/123 (3.25%)  6 /118  4/118 (3.39%)  4
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1: Control - Caregivers Arm 1: Control - Patients Arm 2: HI-FIVES - Caregivers Arm 2: HI FIVES - Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/123 (0.00%)      60/123 (48.78%)      0/118 (0.00%)      57/118 (48.31%)    
Gastrointestinal disorders         
ED Visit *  /123  13/123 (10.57%)  17 /118  8/118 (6.78%)  13
General disorders         
ED Visit *  /123  6/123 (4.88%)  7 /118  12/118 (10.17%)  12
Infections and infestations         
ED Visit *  /123  19/123 (15.45%)  24 /118  9/118 (7.63%)  12
Injury, poisoning and procedural complications         
ED Visit *  /123  17/123 (13.82%)  18 /118  22/118 (18.64%)  34
Musculoskeletal and connective tissue disorders         
ED Visit *  /123  21/123 (17.07%)  29 /118  17/118 (14.41%)  20
Nervous system disorders         
ED Visit *  /123  5/123 (4.07%)  5 /118  6/118 (5.08%)  7
Respiratory, thoracic and mediastinal disorders         
ED Visit *  /123  6/123 (4.88%)  7 /118  2/118 (1.69%)  2
Vascular disorders         
ED Visit *  /123  12/123 (9.76%)  17 /118  12/118 (10.17%)  13
*
Indicates events were collected by non-systematic assessment
HI-FIVES was tested in a single VA medical center. It was likely underpowered to detect statistically significant differences in primary outcome due to greater than expected variance. A larger sample size may be needed to detect true differences.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Courtney Van Houtven
Organization: HSR&D/COIN, Durham VAHCS
Phone: (919)286-6936
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01777490     History of Changes
Other Study ID Numbers: IIR 11-345
First Submitted: January 23, 2013
First Posted: January 28, 2013
Results First Submitted: January 8, 2018
Results First Posted: February 28, 2019
Last Update Posted: February 28, 2019