NCT03474380

Brief Summary

Optimizing Function and Independence Through iHI-FIVES aims to implement the iHI-FIVES caregiver skills training program at 8 VAMC sites in a stepped- wedge design and evaluate caregiver and patient outcomes before and after the program is implemented, as well as the efficacy of a usual vs enhanced implementation design.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,406

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 23, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

June 10, 2024

Completed
Last Updated

June 10, 2024

Status Verified

December 1, 2023

Enrollment Period

2.5 years

First QC Date

February 15, 2018

Results QC Date

February 1, 2022

Last Update Submit

December 21, 2023

Conditions

Functional ImpairmentCognitive Impairment

Keywords

CaregiverVeteransSkills trainingInformal careDays at home

Outcome Measures

Primary Outcomes (1)

  • Patient Number of Days Not at Home

    Count of number of days not at home (e.g. days in emergency department, inpatient hospital, or post-acute facility setting) over 180 days following study determination of eligibility (e.g. referred to home based care and has a caregiver). The outcome will be assessed via administrative data (not patient report). Outcome was at the participant level according to the usual care and intervention as pre-specified in the study protocol. Participants were either in usual care or intervention (offering iHI-FIVES caregiver skills training program at site) based on the 6-month time interval that were identified and/or enrolled at a site.

    180 days

Secondary Outcomes (3)

  • Caregiver Satisfaction With Veteran's VA Care

    Baseline and 3-month follow up

  • Caregiver Subjective Burden

    Baseline and 3-month follow up

  • Caregiver Depressive Symptoms

    Baseline and 3-month follow up

Study Arms (2)

Intervention

EXPERIMENTAL

Implementation of iHI-FIVES program Intervention: Behavioral: iHI-FIVES

Behavioral: iHI-FIVES

Usual Care

NO INTERVENTION

Pre-implementation before iHI-FIVES program

Interventions

iHI-FIVESBEHAVIORAL

Implementation of iHI-FIVES caregiver skills training

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Homemaker home health aide services
  • Home based primary care
  • Adult day health care
  • Respite care
  • Veteran directed care
  • Able and willing to provide informed consent

You may not qualify if:

  • Hospice care
  • Difficulty with or unable to communicate on the telephone, or no telephone access
  • Caregiver is a professional without pre-existing personal relationship with Veteran patient and receives payment for caregiving services (e.g. formal care provider)
  • Their care recipient (the Veteran) is currently in hospital or institution
  • Their care recipient (the Veteran) is currently receiving hospice care
  • Caregiver is a member of the Durham HSR\&D Veteran and Family Input Initiative (VAFII), where members have advised and provided input towards the development of iHI-FIVES intervention materials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (4)

  • Van Houtven CH, Drake C, Malo TL, Decosimo K, Tucker M, Sullivan C, D'Adolf J, Hughes JM, Christensen L, Grubber JM, Coffman CJ, Sperber NR, Wang V, Allen KD, Hastings SN, Shea CM, Zullig LL. Ready, set, go! The role of organizational readiness to predict adoption of a family caregiver training program using the Rogers' diffusion of innovation theory. Implement Sci Commun. 2023 Jun 19;4(1):69. doi: 10.1186/s43058-023-00447-x.

    PMID: 37337208DERIVED

  • Ma JE, Grubber J, Coffman CJ, Wang V, Hastings SN, Allen KD, Shepherd-Banigan M, Decosimo K, Dadolf J, Sullivan C, Sperber NR, Van Houtven CH. Identifying Family and Unpaid Caregivers in Electronic Health Records: Descriptive Analysis. JMIR Form Res. 2022 Jul 18;6(7):e35623. doi: 10.2196/35623.

    PMID: 35849430DERIVED

  • Boucher NA, Zullig LL, Shepherd-Banigan M, Decosimo KP, Dadolf J, Choate A, Mahanna EP, Sperber NR, Wang V, Allen KA, Hastings SN, Van Houtven CH. Replicating an effective VA program to train and support family caregivers: a hybrid type III effectiveness-implementation design. BMC Health Serv Res. 2021 May 6;21(1):430. doi: 10.1186/s12913-021-06448-7.

    PMID: 33952263DERIVED

  • Wang V, Allen K, Van Houtven CH, Coffman C, Sperber N, Mahanna EP, Colon-Emeric C, Hoenig H, Jackson GL, Damush TM, Price E, Hastings SN. Supporting teams to optimize function and independence in Veterans: a multi-study program and mixed methods protocol. Implement Sci. 2018 Apr 20;13(1):58. doi: 10.1186/s13012-018-0748-3.

    PMID: 29678137DERIVED

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Courtney Van Houtven
Organization
HSRD ADAPT
courtney.vanhoutven@va.gov
919-286-6936

Study Officials

  • Susan N. Hastings, MD MHSc

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

  • Courtney H Van Houtven, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

  • Virginia Wang, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Stepped Wedge Cluster Randomized Trial (where clusters are VAMC sites) - a form of crossover design with unidirectional crossover (from control to experimental) but with randomization of when each VAMC site undertakes the transition. In the stepped wedge design, there is a staggered roll-out of the intervention, where the time and sequence of VAMC sites that will start the intervention at each period are determined by random allocation.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2018

First Posted

March 22, 2018

Study Start

April 23, 2018

Primary Completion

October 20, 2020

Study Completion

October 31, 2021

Last Updated

June 10, 2024

Results First Posted

June 10, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Requests can be made for a de-identified, anonymized dataset. Prior to distribution, a local privacy officer and study statistician will certify that the dataset contains no protected health information (PHI). Data will be provided to requestor in electronic format. Sufficient data and descriptors will be made available to duplicate statistical analysis and confirm conclusions in publication. No data or statistical code that could lead to re-identification of individuals will be released. Data will be stored \& maintained in an approved, secured location as described in the VA Research Data Inventory Form.

Shared Documents
ICF
Time Frame
Available upon request.
Access Criteria
Data will only be released per appropriate authorizations or agreements. Written agreements will specify that recipients are prohibited from taking steps to re- identify any individual whose data are included in the dataset.

Locations

US(1)