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NCT01394081: AVRHI

Alabama Veterans Rural Health Initiative

Completed NA Results posted Last updated 23 April 2018
What this trial tests

NA trial testing Enhanced Engagement and Enrollment (EEE) in Problems With Access to Health Care in 203 participants. Completed in 1 October 2013.

Timeline
1 October 2008
Primary endpoint
1 October 2010
1 October 2013

Quick facts

Lead sponsorTuscaloosa Research & Education Advancement Corporation
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposescreening
Enrollment203
Start date1 October 2008
Primary completion1 October 2010
Estimated completion1 October 2013
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Tuscaloosa Research & Education Advancement Corporation

Who can join

19 and older, any sex, with Problems With Access to Health Care or Health Behavior. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Attendance at a VA Appointment Primary · 6 months

Attendance at a VA appointment was derived from VA clinical records, defined as the participant attending a scheduled VA clinic appointment. Participants who did not attend a VA clinic appointment be the end of 6-month observation period were classified as censored at 6 months.

GroupValue95% CI
Enhanced Enrollment and Engagement(EEE)88
Administrative Outreach (AO)59
Days Until VA Clinic Appointment Secondary · 6 months

The number of days from day of randomization to day that the participant attended the VA clinic appointment (derived from the VA medical records). Participants who did not attend a VA clinic appointment be the end of 6-month observation period were classified as censored at 6 months.

GroupValue95% CI
Enhanced Enrollment and Engagement (EEE)12± 49.8
Administrative Outreach (AO)98± 93.1

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Enhanced Enrollment and Engagement (EEE)
Serious: 1/101 (1%)
Deaths: 0/101
Administrative Outreach (AO)
Serious: 2/102 (2%)
Deaths: 0/102

Serious adverse events (3 terms)

ReactionSystemEnhanced Enrollment and En…Administrative Outreach (AO)
HospitalizationCardiac disorders
Death resulting from heart attackCardiac disorders
HospitalizationVascular disorders

Most-reported serious reactions: Hospitalization, Death resulting from heart attack, Hospitalization.

Data from ClinicalTrials.gov NCT01394081 adverse events section.

Sponsor's own description

The purpose of the Alabama Veterans Rural Health Initiative is to better understand access and barriers to health care and to enhance veteran enrollment or engagement in health care services of veterans residing in rural areas. It describes an intervention that is adaptable for use by other VA facilities that serve veterans in rural settings, and importantly, this study will improve our understanding of barriers to care and evaluate a method for enhancing access to care. The anticipated impact is that more veterans in rural areas who were previously under-utilizing VA services will receive and attend a health care appointment. This gain may improve preventative and primary care health care and reduce long term health care morbidity, expense and burden. This study may also identify previously unknown barriers to care that can be surmounted by innovative access and health care delivery approaches. The primary objective is to evaluate an innovative approach for enhanced enrollment and engagement outreach intervention (EEE intervention) for rural veterans in VA health care services. This study entails a two-cell design, addressing this objective with a prospective, randomized controlled multi-site clinical trial that evaluates an active intervention compared to administrative outreach (AO, control condition) on whether or not a rurally-residing veteran obtains and attends a VA appointment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01394081.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing