Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
Study NCT ID:
NCT02827695
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2016-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smart Phone Medication Adherence Saves Kidneys--SMASK
Sponsor:
Medical University of South Carolina
Organization:
Study Overview
Official Title:
Smart Phone Medication Adherence Saves Kidneys--SMASK
Status:
COMPLETED
Status Verified Date:
2020-10
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:
Investigators will employ a 2-arm Randomized Controlled Trial (RCT) design with the subject as the unit of randomization and analysis. Kidney transplant recipients having uncontrolled hypertension will be enrolled into a screening phase to measure medication non-adherence. Each subject will use an electronic pill tray for 1 month without any reminder functions activated. Non-adherent subjects who remain uncontrolled will be randomly assigned to SMASK or Standard Care (SC). SC will continue to use the pill tray with reminders turned off and will receive attention control texts with healthy lifestyle information. SMASK will have the reminder functions of the electronic pill tray activated and will receive a Bluetooth blood pressure monitor and an app to collect the data and send to researchers.
Subjects in the second phase will participate in 4 more evaluations at months 1, 3, 6, 12 post randomization. Research staff will measure resting blood pressure and heart rate.
Subjects in the second phase will participate in 4 more evaluations at months 1, 3, 6, 12 post randomization. Research staff will measure resting blood pressure and heart rate.
Detailed Description:
A randomized RCT will be conducted with kidney transplant patients identified as hypertensive (\>129 SBP following KDIGO guidelines) via medical history. Those identified as being nonadherent for 4 weeks during the first month post enrollment (adherence score \<0.85) will be eligible to participate in the second phase. Participants in the second phase will be randomly assigned to standard care (SC) + attention control or the mHealth program plus SC.
Following informed written consent, eligible patients will be asked to complete several brief surveys aimed at determining, mood state, perceived stress, self-efficacy assessment, comfort with mHealth devices, perceptions of treatment burden and attitudes towards mhealth. Subjects will have their blood pressure measured and if SBP is \>129 they will enter the screening phase. Subjects will be provided a Medication dispensing device system. Subjects will be called the following day to check if there were any problems in filling the Simplemed tray.
The Simplemed has four compartments for each day of the week for potential use. Microelectronic circuitry in each compartment on the tray date stamps the opening of each compartment and removal of the refill tray. These signals are relayed via an internal modem to a server for processing. Data can then be sent directly into the MUSC server that compiles individuals' health data from multiple delivery points. Adherence rate across the first month will be calculated at weekly intervals.
All subjects will return for a visit at the end of their 4 week screening period. Those with an adherence score \<0.85 for 4 weeks and whose SBP continues to be \>129 will be invited to participate in the second phase of the RCT. Evaluations performed at this visit will include anthropometrics, questionnaires, and resting BP. A Spacelabs ABP monitor will be applied with instructions for wearing the monitor 24 hrs. The subjects will be randomized to SMASK+SC or SC+ attention control groups after the baseline procedures are completed. Those with med adherence score ≥0.85 or who have SBP ≤ 129 will return their pill tray but not proceed into the second phase. Recruitment will end when 80 subjects have successfully transitioned into the second phase (RCT) of the study.
The SC+ attention control group will continue to use Simplemed with reminder functions disabled, they will be sent daily text messages or links to PDF documents or videos containing health information as attention control. The SMASK mhealth intervention group will also receive SC and have the Simplemed reminder functions turned on (blink for ½ hr when medication is due, chime additional ½ hr, then text or email after 1 hour) and receive training in use of the A\&D BP monitor. They will be instructed to measure their blood pressure twice daily AM, PM) on at least every third day. Patients will be provided with and shown how to use the smart phone app and activate the app when they record their blood pressure readings.
Following informed written consent, eligible patients will be asked to complete several brief surveys aimed at determining, mood state, perceived stress, self-efficacy assessment, comfort with mHealth devices, perceptions of treatment burden and attitudes towards mhealth. Subjects will have their blood pressure measured and if SBP is \>129 they will enter the screening phase. Subjects will be provided a Medication dispensing device system. Subjects will be called the following day to check if there were any problems in filling the Simplemed tray.
The Simplemed has four compartments for each day of the week for potential use. Microelectronic circuitry in each compartment on the tray date stamps the opening of each compartment and removal of the refill tray. These signals are relayed via an internal modem to a server for processing. Data can then be sent directly into the MUSC server that compiles individuals' health data from multiple delivery points. Adherence rate across the first month will be calculated at weekly intervals.
All subjects will return for a visit at the end of their 4 week screening period. Those with an adherence score \<0.85 for 4 weeks and whose SBP continues to be \>129 will be invited to participate in the second phase of the RCT. Evaluations performed at this visit will include anthropometrics, questionnaires, and resting BP. A Spacelabs ABP monitor will be applied with instructions for wearing the monitor 24 hrs. The subjects will be randomized to SMASK+SC or SC+ attention control groups after the baseline procedures are completed. Those with med adherence score ≥0.85 or who have SBP ≤ 129 will return their pill tray but not proceed into the second phase. Recruitment will end when 80 subjects have successfully transitioned into the second phase (RCT) of the study.
The SC+ attention control group will continue to use Simplemed with reminder functions disabled, they will be sent daily text messages or links to PDF documents or videos containing health information as attention control. The SMASK mhealth intervention group will also receive SC and have the Simplemed reminder functions turned on (blink for ½ hr when medication is due, chime additional ½ hr, then text or email after 1 hour) and receive training in use of the A\&D BP monitor. They will be instructed to measure their blood pressure twice daily AM, PM) on at least every third day. Patients will be provided with and shown how to use the smart phone app and activate the app when they record their blood pressure readings.
Study Oversight
Has Oversight DMC:
False
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?: