Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129454
Status:
COMPLETED
Last Update Posted:
2017-06-06
First Post:
2005-08-09
Brief Title:
Telemedicine Treatment for Veterans With Gulf War Illness
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Telemedicine Treatment for Veterans With Gulf War Illness
Status:
COMPLETED
Status Verified Date:
2017-06
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:
None
Brief Summary:
Effective treatments have been developed to ameliorate symptom-related distress and reduce unnecessary healthcare utilization using cognitive-behavioral techniques CBT However there is a major limitation of this treatment is that patients must attend sessions in person The specific aims of the study are to 1 Determine the clinical efficacy of Telephone CBT for veterans with GWI who are frequent consumers of ambulatory medical care 2 Determine whether CBT for veterans with GWI leads to a reduction in the cost of VA health care and 3 Develop a statistical model of treatment seeking in veterans with GWI who are frequent consumers of ambulatory medical care
Detailed Description:
At least as far back as the American Civil War soldiers have reported nonspecific ailments that could not be attributed to an underlying medical cause The most frequent symptoms include persistent fatigue palpitations headache muscle or joint pain disturbed sleep and cognitive difficulties Recent epidemiologic studies suggest that war-related syndromes are exceptionally common in deployed personnel and may affect 45 to 60 of returning soldiers These post-deployment symptoms have substantial consequences that include increased medical visitation increased physical disability and increased psychological distress The number of veterans at risk is likely to increase rather than decrease in the years ahead In order to address this anticipated increase new and more efficient treatments for symptom-based illness are urgently needed to augment or replace standard VA care An effective treatment using cognitive-behavioral techniques CBT has been developed to ameliorate symptom-related distress and reduce unnecessary healthcare utilization Despite convincing evidence of therapeutic efficacy a major limitation of this treatment is that patients must attend sessions in person This requirement may undermine the effectiveness of CBT since fewer than half of those who need treatment will attend A recent trial of CBT for veterans with Gulf War Illness found that only 38 were treatment adherent Any sudden increase in the number of veterans seeking care could overwhelm the limited resources of a local VA healthcare center The proposed study will address this important public health problem by testing a cost-effective and innovative strategy for delivering CBT over the phone
The specific aims of the study are to 1 Determine the clinical efficacy of Telephone CBT for veterans with GWI who are frequent consumers of ambulatory medical care 2 Determine whether CBT for veterans with GWI leads to a reduction in the cost of VA health care and 3 Develop a statistical model of treatment seeking in veterans with GWI who are frequent consumers of ambulatory medical care
Participation is limited to veterans who satisfy a validated case definition of GWI and whose utilization is at or above the 80th percentile A long-term goal of the proposed research is to make specialized Telephone CBT services widely available to veterans regardless of their geographic location A previously validated CBT program for GWI has been adapted in consultation with Dr Charles Engel The proposed study represents the first randomized multicenter trial of Telephone CBT designed to ameliorate GWI and reduce unnecessary reliance on VA health care services A total of 150 eligible veterans will be assigned to one of three groups I Telephone CBT Customary Medical Care II In-Person CBT Customary Medical Care or III Customary Medical Care only
Revised study procedures were developed and approved by our local IRB CBT manual was refined and adapted for telephone use Two postdoctoral fellows were recruited trained in CBT and study assessment techniques A large pool of high utilizing veterans was identified Of the first 1000 veteran names 523 were not viable after chart review outside catchment area medical rule out moved deceased etc of 477 remaining 147 were not reachable 102 declined 46 were deemed ineligible after initial screening 49 were eligible and scheduled for psychiatric interview As of December 2006 a total of 116 veterans have been enrolled in the study and randomized to treatment
The specific aims of the study are to 1 Determine the clinical efficacy of Telephone CBT for veterans with GWI who are frequent consumers of ambulatory medical care 2 Determine whether CBT for veterans with GWI leads to a reduction in the cost of VA health care and 3 Develop a statistical model of treatment seeking in veterans with GWI who are frequent consumers of ambulatory medical care
Participation is limited to veterans who satisfy a validated case definition of GWI and whose utilization is at or above the 80th percentile A long-term goal of the proposed research is to make specialized Telephone CBT services widely available to veterans regardless of their geographic location A previously validated CBT program for GWI has been adapted in consultation with Dr Charles Engel The proposed study represents the first randomized multicenter trial of Telephone CBT designed to ameliorate GWI and reduce unnecessary reliance on VA health care services A total of 150 eligible veterans will be assigned to one of three groups I Telephone CBT Customary Medical Care II In-Person CBT Customary Medical Care or III Customary Medical Care only
Revised study procedures were developed and approved by our local IRB CBT manual was refined and adapted for telephone use Two postdoctoral fellows were recruited trained in CBT and study assessment techniques A large pool of high utilizing veterans was identified Of the first 1000 veteran names 523 were not viable after chart review outside catchment area medical rule out moved deceased etc of 477 remaining 147 were not reachable 102 declined 46 were deemed ineligible after initial screening 49 were eligible and scheduled for psychiatric interview As of December 2006 a total of 116 veterans have been enrolled in the study and randomized to treatment
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