NCT01777490|CompletedResults
Helping Invested Families Improve Veterans Experiences Study
HI-FIVES
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HI-FIVES
Sponsor study identifier
interventional
484
1 country
1
Study Start
February 5, 2014
Actual (reported)Primary Completion
January 10, 2017
Actual (reported)Study Completion
December 29, 2017
Actual (reported)The purpose of this study is to evaluate a caregiver skill training program (HI-FIVES), offered as a part of a randomized control trial to caregivers of Veterans referred to home and community-based long-term care. Of primary interest is to examine whether participating in HI-FIVES leads to clinically significant increases in days spent at home for Veterans compared to caregivers in usual care. The investigators aim, through the training, to decrease the number of days over 12 months post-intervention that Veterans spend in the emergency department, hospital, or nursing home. Days spent in these settings reduces the Veteran's quality of life and increases health care costs to the VA. The investigators also will evaluate whether caregivers in HI-FIVES have clinically significant reductions in depressive symptoms post-intervention compared to caregivers in usual care.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 29, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 23, 2013
Actual (reported)January 28, 2013
Actual (reported)February 5, 2014
Actual (reported)January 10, 2017
Actual (reported)December 29, 2017
Actual (reported)February 28, 2019
Actual (reported)Patient Days in the Community (e.g. Days Not in Emergency Department, Inpatient, or Nursing Home Setting)
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.
12 months
Total Costs to the VA
12 months
Satisfaction With Healthcare
3 months
Caregivers in the control arm will be referred to the VA Caregiver Support Program (usual care), as a resource for them as they care for the patient in the home.
Caregivers will take part in three phone training sessions and will attend four group training sessions at the VA. They will also be given the option of participating in 2 booster phone training sessions post-group sessions. Caregivers will be asked to provide one in-person (baseline) and three phone assessments (3, 9, and 15 months). Patients will also be enrolled and contact will be limited to assessments
Usual care will be the Veteran patient care and caregiver support that are normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This process entails the patient and caregiver work with the social worker assigned to the patient to obtain home and community based care (HCBC) services. The patients in the usual care group will be free to seek medical, psychological, social support, and social services that are available through VAMCs or any other source. In addition to this, caregivers in the usual care arm will be told about the caregiver support programs in the VHA and the caregiver will receive the national VA caregiver hotline phone number. The information provided mirrors efforts to support caregivers in the VA nationally and new standards of care for VA caregivers. This will be the only contact with the usual care subjects besides the scheduled data collection assessments.
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705, United States
Van Houtven CH, Oddone EZ, Hastings SN, Hendrix C, Olsen M, Neelon B, Lindquist J, Weidenbacher H, Boles J, Chapman J, Weinberger M. Helping Invested Families Improve Veterans' Experiences Study (HI-FIVES): study design and methodology. Contemp Clin Trials. 2014 Jul;38(2):260-9. doi: 10.1016/j.cct.2014.05.003. Epub 2014 May 14.
Shepherd-Banigan M, Smith VA, Lindquist JH, Cary MP Jr, Miller KEM, Chapman JG, Van Houtven CH. Identifying treatment effects of an informal caregiver education intervention to increase days in the community and decrease caregiver distress: a machine-learning secondary analysis of subgroup effects in the HI-FIVES randomized clinical trial. Trials. 2020 Feb 14;21(1):189. doi: 10.1186/s13063-020-4113-x.
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.
Courtney H Van Houtven, PhD
Durham VA Medical Center, Durham, NC
484 participants (actual enrollment reported by the registry).
First Submitted
January 23, 2013
First Posted
January 28, 2013
Study Start
February 5, 2014
Actual (reported)Pilot Study of Hospital GamePlan4Care
Caregiver Depressive Symptoms
3 months
The patient of each caregiver will also be enrolled and contact will be limited to assessments.
The patient of each caregiver will also be enrolled and contact will be limited to assessments.
In addition to the usual care activities outline in the Control arm, Caregivers in the HI-FIVES group will receive three individual calls with a nurse educator to address topics he/she identified as being the highest priority learning areas. The calls will be tailored to the individual needs of Veteran-caregiver dyad. After the phone calls, caregivers will participate in four evidence-based group sessions aimed to improve clinical care skills, psychological care skills, and support-seeking skills. The curriculum will be delivered by a trained nurse educator and the PI and VA Caregiver Support Staff. The sessions will be targeted to address common needs of Veterans and their caregivers. After the final group session, there will be two optional booster calls at one and three months. Four assessments in all will be collected, baseline (in person), and at 3, 9, and 15 months (by phone).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 10, 2017
Actual (reported)Study Completion
December 29, 2017
Actual (reported)Last Updated
February 28, 2019
Results First Posted
February 28, 2019
Record last verified: 2018-10
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Source: ClinicalTrials.gov.
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