Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071500
Status:
UNKNOWN
Last Update Posted:
2008-09-26
First Post:
2003-10-24
Brief Title:
An Electronic Pillbox for People With HIV
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Novel Technology to Improve HIV Medication Compliance
Status:
UNKNOWN
Status Verified Date:
2008-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Anti-HIV drug regimens can be very complicated This study will evaluate a new electronic pillbox designed to help people take their anti-HIV drugs correctly
Detailed Description:
Recent advances in antiretroviral therapy have allowed for almost complete inhibition of viral replication in HIV-infected individuals Unfortunately the ability of the virus to rapidly mutate and become resistant to treatments necessitates the administration of multiple medications in complex dosing schedules to maintain viral suppression Although adherence to these complicated treatment regimens is paramount even the most vigilant persons often have difficulty maintaining these protocols for extended periods of time
MedSignals is an electronic device that was designed to improve medication compliance among HIV patients It allows convenient storage and transport of antiretroviral medications and functions as an aid to compliance by incorporating reminding alarms at dosing times and usage reporting functions The system alarms at pill times records pill-taking communicates usage data to servers and displays progress charts on personalized web pages Four separately-controlled compartments are easily set for number of dosings per day and number of pills at each dosing Thereafter all alarms are relative to last lid openings assuring intake is optimally spaced Additional menu options can be set to advise when lids are opened such as take with food Lid openings are time-stamped in memory The cradle is permanently plugged into telephone and electrical lines for uploading of data and recharging but the pillbox is portable and pocket-sized Every day sensors detect a phone line and upload usage data to servers allowing authorized caregivers or the patient to observe compliance records This trial will evaluate MedSignals usability and functionality in increasing medication compliance in people infected with HIV
Participants will be randomly assigned to one of three study groups each group will contain 25 participants One group will use MedSignals with all of its features one group will use MedSignals with only alarm features and the final group will not use any device Participants will have 4 study visits over 9 weeks and one follow-up telephone call after 6 months Assessments will include demographic and usability questionnaires
MedSignals is an electronic device that was designed to improve medication compliance among HIV patients It allows convenient storage and transport of antiretroviral medications and functions as an aid to compliance by incorporating reminding alarms at dosing times and usage reporting functions The system alarms at pill times records pill-taking communicates usage data to servers and displays progress charts on personalized web pages Four separately-controlled compartments are easily set for number of dosings per day and number of pills at each dosing Thereafter all alarms are relative to last lid openings assuring intake is optimally spaced Additional menu options can be set to advise when lids are opened such as take with food Lid openings are time-stamped in memory The cradle is permanently plugged into telephone and electrical lines for uploading of data and recharging but the pillbox is portable and pocket-sized Every day sensors detect a phone line and upload usage data to servers allowing authorized caregivers or the patient to observe compliance records This trial will evaluate MedSignals usability and functionality in increasing medication compliance in people infected with HIV
Participants will be randomly assigned to one of three study groups each group will contain 25 participants One group will use MedSignals with all of its features one group will use MedSignals with only alarm features and the final group will not use any device Participants will have 4 study visits over 9 weeks and one follow-up telephone call after 6 months Assessments will include demographic and usability questionnaires
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 |
|---|---|---|---|
| 1R43AI052634-01 | NIH | None | httpsreporternihgovquickSearch1R43AI052634-01 |