Ignite Creation Date:
2024-05-06 @ 1:33 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01831830
Status:
COMPLETED
Last Update Posted:
2015-06-24
First Post:
2013-04-11
Brief Title:
Evaluation of the Veterans In-home Program
Sponsor:
Corporal Michael J Crescenz VA Medical Center
Organization:
Corporal Michael J Crescenz VA Medical Center
Study Overview
Official Title:
Evaluation of the Veterans In-home Programs for Veterans With TBI and Families
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIP
Brief Summary:
The primary objective of this study is to evaluate the preliminary effectiveness and acceptability of an innovative in-home nonpharmacological intervention the Veterans In-home Program VIP for Veterans with mild to moderate traumatic brain injury TBI and their families VIP is designed to promote community reintegration improve quality of life and support functioning by realigning environmental demands to match the Veterans abilities
Detailed Description:
Research Design Using a 2-group randomized control trial the investigators will evaluate the intervention in comparison to usual care Usual care is traditional clinic-based care which will be enhanced by 2 phone calls to provide an attention control condition
Methodology Participants will be 100 Veterans diagnosed with mild to moderate TBI who are followed by the Philadelphia VA Medical Center PVAMC Polytrauma Service and a family member 100 of each Veteran All Veterans will have a family member or partner living with them who is willing to participate in the study The intervention and study interviews will occur in Veterans homes Qualitative phone interviews with a subset of the sample who received the intervention will be conducted at PVAMC
Primary study outcomes for the Veterans will be physical cognitive and emotionalinterpersonal functioning and community reintegration measured by standardized instruments at baseline and follow-up at 3 to 4 months Study outcomes for family members will be mood and dimensions of well-being measured by standardized instruments at baseline and follow-up at 3 to 4 months Acceptability of the intervention for Veterans and family members will be measured through Project Evaluations administered at follow-up with both groups In addition qualitative phone interviews will be conducted with a subset of Veterans and family members who received VIP to evaluate VIPs acceptability and to enhance understanding of the impact of VIP from the perspective of those experiencing it
Based on a person-environment fit framework the VIP intervention consists of 8 sessions up to 6 in the home and 2 telephone contacts delivered by occupational therapists over a 3 month period to Veterans and family members VIP realigns environmental demands to match Veterans abilities through the modification of home environments development of meaningful activities tailored to Veterans strengths training in the use of emotion-regulation strategies to address behavioralinterpersonal difficulties and training in the use of cognitive strategies to compensate for cognitive impairments In its family focus VIP provides family members with education and training to understand and manage the Veterans limitations
Clinical relationships VIP extends and adds value to traditional on-site clinical care by helping individuals with TBI and their families in the setting where most functional and behavioral problems emerge As a skills-building intervention VIP has the potential to enhance Veterans abilities to function effectively in their home environments and to improve their quality of life and that of their families
Methodology Participants will be 100 Veterans diagnosed with mild to moderate TBI who are followed by the Philadelphia VA Medical Center PVAMC Polytrauma Service and a family member 100 of each Veteran All Veterans will have a family member or partner living with them who is willing to participate in the study The intervention and study interviews will occur in Veterans homes Qualitative phone interviews with a subset of the sample who received the intervention will be conducted at PVAMC
Primary study outcomes for the Veterans will be physical cognitive and emotionalinterpersonal functioning and community reintegration measured by standardized instruments at baseline and follow-up at 3 to 4 months Study outcomes for family members will be mood and dimensions of well-being measured by standardized instruments at baseline and follow-up at 3 to 4 months Acceptability of the intervention for Veterans and family members will be measured through Project Evaluations administered at follow-up with both groups In addition qualitative phone interviews will be conducted with a subset of Veterans and family members who received VIP to evaluate VIPs acceptability and to enhance understanding of the impact of VIP from the perspective of those experiencing it
Based on a person-environment fit framework the VIP intervention consists of 8 sessions up to 6 in the home and 2 telephone contacts delivered by occupational therapists over a 3 month period to Veterans and family members VIP realigns environmental demands to match Veterans abilities through the modification of home environments development of meaningful activities tailored to Veterans strengths training in the use of emotion-regulation strategies to address behavioralinterpersonal difficulties and training in the use of cognitive strategies to compensate for cognitive impairments In its family focus VIP provides family members with education and training to understand and manage the Veterans limitations
Clinical relationships VIP extends and adds value to traditional on-site clinical care by helping individuals with TBI and their families in the setting where most functional and behavioral problems emerge As a skills-building intervention VIP has the potential to enhance Veterans abilities to function effectively in their home environments and to improve their quality of life and that of their families
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R21HD068857-01 | NIH | None | httpsreporternihgovquickSearch1R21HD068857-01 |