CaregiverHI-FIVESNCT01777490
Helping Invested Families Improve Veterans Experiences Study
A study testing Helping Invested Families Improve Veterans Experiences - HI FIVES in people with Caregiver and Disabled Veterans, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver, Disabled Veterans, Referred to Long-term Care
- What is being tested?
- Helping Invested Families Improve Veterans Experiences - HI FIVES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2014to 29 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient referred to home and community-based services in the past 3 months,
- not eligible for hospice,
- residing at home,
- has an informal caregiver, and willing to let us contact the caregiver.
- To be referred successfully to HCBC,
- patients will have a minimum of 2 activity of daily living limitations,
- and are likely to have multimorbidity, including high rates of cognitive impairment.
Who cannot join
- Cognitively impaired Caregiver
- Caregiver does not have access to a telephone.
- Severely impaired hearing or speech (Caregivers must be able to respond to phone calls).
- English Language Impaired - Caregiver
- Substance Abuse Disorders - Caregiver
- Caregiver participating in other caregiver intervention
Show all 9Show fewer
- Patient referred only for physical or occupational therapy
- Patient or caregiver refuses informed consent
- Patient in hospital
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
About this study
Official title: Helping Invested Families Improve Veterans Experiences Study (HI-FIVES)
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.
Read the detailed description
Anticipated Impacts on Veteran's Healthcare: Designing and implementing a training program for informal caregivers of functionally impaired Veterans (HI-FIVES) will enhance Veterans' ability to remain in their homes and satisfaction with care, as well as lower VA costs. Caregiver training can also improve caregiver wellbeing by alleviating feelings of depression and burden, which can also improve the care they provide to veterans. The investigators' caregiver training program is consistent with features of two recent national policy changes aimed to improve quality of care for veterans. First, providing training to informal caregivers of functionally impaired veterans is consistent with the 2000 Millennium Health Care Act, which mandated an unprecedented expansion in long-term care benefits to Veterans, and stipulated that, whenever possible, care be provided in the least restrictive environment possible-the home. Second, The Caregivers and Veterans Omnibus Health Services Act of 2010 mandated unprecedented support for informal caregivers of severely injured Operation Enduring Freedom/Operation Iraqi Freedom(OEF/OIF) Veterans, including providing caregiver training to informal caregivers of any era veteran. Achieving higher quality informal care supports both of these mandates. By partnering with VA providers, HI-FIVES will improve the skill of caregivers, thereby improving veteran health care quality and the ability for veterans to remain at home.
Project Background: Caregiver burnout, strain and burden are associated with caregiver depression and patient institutionalization. Furthermore, lack of skills among caregivers can lead to depression and anxiety as well as patient institutionalization. The investigators propose to evaluate an innovative program that supports and trains informal caregivers when veterans are referred to Veterans Health Administration (VHA) home and community-based care (HCBC), a critical moment in a veteran's VHA health care use trajectory. Referral to HCBC is a time when caregivers may face personal strain and uncertainty about demands involved in caregiving. As such, it presents a teachable moment to train caregivers to better meet the demands imposed by caregiving.
Project Objectives: To evaluate whether over 12 months, veterans with caregivers in the skill training program have clinically significant increases in days at home than veterans in usual care (e.g. days not in emergency department, hospital, or nursing home). In addition, the investigators will evaluate whether veterans in the skill training program have significantly lower VA costs of medical care or higher satisfaction with VHA over 6 and 12 months than veterans in usual care. Finally, the investigators will evaluate whether caregivers in the skill training program have clinically significant reductions in depressive symptoms, subjective burden, or increased satisfaction with VA healthcare at 6 and12 months than caregivers in usual care.
Project Methods: The study is a randomized controlled trial with data collection from caregiver-patient dyads before and after training, and at 6 and 12 months after program completion. Piloted in early 2012, the setting is the Social Work Service at the Durham VA Medical Center (VAMC). Patient inclusion criteria are patient referred to home and community-based services in the past 3 months, not eligible for hospice, residing at home, has an informal caregiver, and willing to let investigators contact the caregiver. Caregivers must be cognitively and physically capable to participate, understand English, not be treated for a substance abuse disorder, not be in another caregiver interventional study, and willing to participate in 3 phone call trainings and attend five group sessions at the VA. Caregivers in the control group will receive the training and support usually provided by HCBC and VA medical providers. To be referred successfully to HCBC, patients will have a minimum of 2 activity of daily living limitations, and are likely to have multimorbidity, including high rates of cognitive impairment (44% in the pilot). The target sample size will be 146 caregivers in each arm. Patient involvement will be limited to four short phone assessments (with mechanisms established for proxy respondents). Caregivers in the treatment arm will take part in three phone training sessions and five group sessions, and in both arms caregivers will be asked to provide four phone assessments. Descriptive statistics will be used to summarize all study variables. Of primary importance will be to examine the distribution of patient days spent at home during the first 3 months, the first 6 months, and over the entire 12 months of the post-intervention period (e.g. days not in ED, inpatient, or nursing home setting). Investigators will use the count-data regression model which best fits the investigators' data (Poisson, Negative Binomial or zero-inflated versions of Poisson or Negative Binomial) to test the primary hypothesis that veterans with caregivers in the skill training program will have significantly more days spent at home than veterans in usual care.
- Conditions
- Caregiver, Disabled Veterans, Referred to Long-term Care, Residing at Home, Hospice Ineligible
- Being tested
- Helping Invested Families Improve Veterans Experiences - Control, Helping Invested Families Improve Veterans Experiences - HI FIVES
- Keywords
- Caregivers - Not professionals, Frail Elderly, Long-term Care, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helping Invested Families Improve Veterans Experiences - ControlBehavioural
Also called Control
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.
Helping Invested Families Improve Veterans Experiences - HI FIVESBehavioural
Also called Experimental
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).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Control - Caregiver | Active comparator | 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. Receives: Behavioral: Helping Invested Families Improve Veterans Experiences - Control |
| Arm 2: HI FIVES - Caregiver | Experimental | 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 Receives: Behavioral: Helping Invested Families Improve Veterans Experiences - HI FIVES |
| Arm 1: Control - Patient | Active comparator | The patient of each caregiver will also be enrolled and contact will be limited to assessments. Receives: Behavioral: Helping Invested Families Improve Veterans Experiences - Control |
| Arm 2: HI-FIVES - Patient | Experimental | The patient of each caregiver will also be enrolled and contact will be limited to assessments. Receives: Behavioral: Helping Invested Families Improve Veterans Experiences - HI FIVES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
Total Costs to the VA
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.
Measured: 12 months
Satisfaction With Healthcare
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.
Measured: 3 months
Caregiver Depressive Symptoms
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study start5 Feb 2014
- Primary completion10 Jan 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Courtney H Van Houtven, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777490
- Sponsor's protocol ID
- IIR 11-345
- Acronym
- HI-FIVES
- Status last verified
- Oct 2018
- First submitted
- 23 Jan 2013
- Last updated
- 28 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24837544Shepherd-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.
PubMed 32059687
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Invested Families Improve Veterans Experiences Study (HI-FIVES)
- ClinicalTrials.gov ID
- NCT01777490
- Acronym / sponsor ID
- HI-FIVES / IIR 11-345
- Conditions
- Caregiver, Disabled Veterans, Referred to Long-term Care, Residing at Home, Hospice Ineligible
- Keywords
- Caregivers - Not professionals, Frail Elderly, Long-term Care, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 5 Feb 2014 (actual)
- Primary completion
- 10 Jan 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 28 Jan 2013 (estimated)
- Results
- Posted 28 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anticipated Impacts on Veteran's Healthcare: Designing and implementing a training program for informal caregivers of functionally impaired Veterans (HI-FIVES) will enhance Veterans' ability to remain in their homes and satisfaction with care, as well as lower VA costs. Caregiver training can also improve caregiver wellbeing by alleviating feelings of depression and burden, which can also improve the care they provide to veterans. The investigators' caregiver training program is consistent with features of two recent national policy changes aimed to improve quality of care for veterans. First, providing training to informal caregivers of functionally impaired veterans is consistent with the 2000 Millennium Health Care Act, which mandated an unprecedented expansion in long-term care benefits to Veterans, and stipulated that, whenever possible, care be provided in the least restrictive environment possible-the home. Second, The Caregivers and Veterans Omnibus Health Services Act of 2010 mandated unprecedented support for informal caregivers of severely injured Operation Enduring Freedom/Operation Iraqi Freedom(OEF/OIF) Veterans, including providing caregiver training to informal caregivers of any era veteran. Achieving higher quality informal care supports both of these mandates. By partnering with VA providers, HI-FIVES will improve the skill of caregivers, thereby improving veteran health care quality and the ability for veterans to remain at home.
Project Background: Caregiver burnout, strain and burden are associated with caregiver depression and patient institutionalization. Furthermore, lack of skills among caregivers can lead to depression and anxiety as well as patient institutionalization. The investigators propose to evaluate an innovative program that supports and trains informal caregivers when veterans are referred to Veterans Health Administration (VHA) home and community-based care (HCBC), a critical moment in a veteran's VHA health care use trajectory. Referral to HCBC is a time when caregivers may face personal strain and uncertainty about demands involved in caregiving. As such, it presents a teachable moment to train caregivers to better meet the demands imposed by caregiving.
Project Objectives: To evaluate whether over 12 months, veterans with caregivers in the skill training program have clinically significant increases in days at home than veterans in usual care (e.g. days not in emergency department, hospital, or nursing home). In addition, the investigators will evaluate whether veterans in the skill training program have significantly lower VA costs of medical care or higher satisfaction with VHA over 6 and 12 months than veterans in usual care. Finally, the investigators will evaluate whether caregivers in the skill training program have clinically significant reductions in depressive symptoms, subjective burden, or increased satisfaction with VA healthcare at 6 and12 months than caregivers in usual care.
Project Methods: The study is a randomized controlled trial with data collection from caregiver-patient dyads before and after training, and at 6 and 12 months after program completion. Piloted in early 2012, the setting is the Social Work Service at the Durham VA Medical Center (VAMC). Patient inclusion criteria are patient referred to home and community-based services in the past 3 months, not eligible for hospice, residing at home, has an informal caregiver, and willing to let investigators contact the caregiver. Caregivers must be cognitively and physically capable to participate, understand English, not be treated for a substance abuse disorder, not be in another caregiver interventional study, and willing to participate in 3 phone call trainings and attend five group sessions at the VA. Caregivers in the control group will receive the training and support usually provided by HCBC and VA medical providers. To be referred successfully to HCBC, patients will have a minimum of 2 activity of daily living limitations, and are likely to have multimorbidity, including high rates of cognitive impairment (44% in the pilot). The target sample size will be 146 caregivers in each arm. Patient involvement will be limited to four short phone assessments (with mechanisms established for proxy respondents). Caregivers in the treatment arm will take part in three phone training sessions and five group sessions, and in both arms caregivers will be asked to provide four phone assessments. Descriptive statistics will be used to summarize all study variables. Of primary importance will be to examine the distribution of patient days spent at home during the first 3 months, the first 6 months, and over the entire 12 months of the post-intervention period (e.g. days not in ED, inpatient, or nursing home setting). Investigators will use the count-data regression model which best fits the investigators' data (Poisson, Negative Binomial or zero-inflated versions of Poisson or Negative Binomial) to test the primary hypothesis that veterans with caregivers in the skill training program will have significantly more days spent at home than veterans in usual care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Control - Caregiver | Active comparator | Behavioral: Helping Invested Families Improve Veterans Experiences - ControlCaregivers 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. |
| Arm 2: HI FIVES - Caregiver | Experimental | Behavioral: Helping Invested Families Improve Veterans Experiences - HI FIVESCaregivers 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 |
| Arm 1: Control - Patient | Active comparator | Behavioral: Helping Invested Families Improve Veterans Experiences - ControlThe patient of each caregiver will also be enrolled and contact will be limited to assessments. |
| Arm 2: HI-FIVES - Patient | Experimental | Behavioral: Helping Invested Families Improve Veterans Experiences - HI FIVESThe patient of each caregiver will also be enrolled and contact will be limited to assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient referred to home and community-based services in the past 3 months,
- not eligible for hospice,
- residing at home,
- has an informal caregiver, and willing to let us contact the caregiver.
- To be referred successfully to HCBC,
Key exclusion criteria (9 listed)
- Cognitively impaired Caregiver
- Caregiver does not have access to a telephone.
- Severely impaired hearing or speech (Caregivers must be able to respond to phone calls).
- English Language Impaired - Caregiver
- Substance Abuse Disorders - Caregiver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helping Invested Families Improve Veterans Experiences - ControlAlso: ControlUsual 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. | Behavioural | Arm 1: Control - Caregiver, Arm 1: Control - Patient |
| Helping Invested Families Improve Veterans Experiences - HI FIVESAlso: ExperimentalIn 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). | Behavioural | Arm 2: HI FIVES - Caregiver, Arm 2: HI-FIVES - Patient |
Primary outcome
Patient Days in the Community (e.g. Days Not in Emergency Department, Inpatient, or Nursing Home Setting)
Time frame: 12 months
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.
3 secondary outcomes
Total Costs to the VA
Time frame: 12 months
Satisfaction With Healthcare
Time frame: 3 months
Caregiver Depressive Symptoms
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24837544Van 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.
- Derived from this study: PubMed 32059687Shepherd-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney H Van Houtven, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helping Invested Families Improve Veterans Experiences - HI FIVES in people with Caregiver and Disabled Veterans, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Days in the Community (e.g. Days Not in Emergency Department, Inpatient, or Nursing Home Setting) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01777490, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.