Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06034301
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2023-09-05
Brief Title:
Pill Bottle vs Reminder App
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Feasibility of Interventions Impacting Medication Adherence
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Current medication adherence interventions are minimally effective which results in higher rates of morbidity and mortality for 45 million US adults who have hypertension and low adherence This feasibility randomized controlled trial seeks to understand the efficacy of reminders and monitoring in the form of a mobile phone application vs usual care on medication adherence as well as the feasibility of the intervention and study procedures This study will compare participants who use a mobile phone app that notifies them when to take their medications intervention group to participants who do not get assigned the app control group for 30 days Medication adherence will be monitored using a Medication Event Monitoring System MEMS cap Both groups will also receive the usual care which will include giving participants a pamphlet about taking their medications The long-term goal of this work is to improve antihypertensive medication adherence and to decrease morbidity and mortality The objective of this application is to test the efficacy of the app based reminders and feedback The hypothesis driving this research is that the intervention will be more effective than the usual care The specific aims are as follows
Detailed Description:
Current medication adherence interventions are minimally effective which results in higher rates of morbidity and mortality for 45 million US adults who have hypertension and low adherence This feasibility randomized controlled trial seeks to understand the efficacy of reminders and monitoring in the form of a mobile phone application vs usual care on medication adherence as well as the feasibility of the intervention and study procedures This study will compare participants who use a mobile phone app that notifies them when to take their medications intervention group to participants who do not get assigned the app control group for 30 days Participants will receive an electronic monitoring cap ie a Medication Event Monitoring System MEMS cap to monitor when they take their antihypertensive medications while they are in the study Both groups will also receive the usual care which will include giving participants a pamphlet about taking their medications The long-term goal of this work is to improve antihypertensive medication adherence and to decrease morbidity and mortality The objective of this application is to test the efficacy of the app based reminders and feedback The hypothesis driving this research is that the intervention will be more effective than the usual care The specific aims are as follows
Aim 1 Compare the efficacy of the app based reminders and feedback with usual care for the primary outcome of medication adherence in 40 adults with hypertension and low adherence
Aim 2 Conduct a robust process evaluation to guide intervention improvements dissemination and implementation in a diverse sample
The hypothesis will be tested for two specific aims in 40 adults 20 control 20 intervention with hypertension and low adherence For these aims the study will be conducted as a phase II single-blind parallel-group randomized controlled trial with diverse adults with hypertension over 30 days Participants will answer surveys about their demographics knowledge about hypertension and their medication adherence They will then be randomized and either be given the standard of care or standard of care plus the intervention app-based reminders and feedback The intervention includes a brief training session on downloading and using the medication reminder app Across arms Participants will track their medication adherence for 30 days using the MEMS cap After the 30 days participants will take surveys about their adherence and knowledge about hypertension and have a brief exit interview with a member of the research team to talk about their experience and debrief them about the study
Aim 1 Compare the efficacy of the app based reminders and feedback with usual care for the primary outcome of medication adherence in 40 adults with hypertension and low adherence
Aim 2 Conduct a robust process evaluation to guide intervention improvements dissemination and implementation in a diverse sample
The hypothesis will be tested for two specific aims in 40 adults 20 control 20 intervention with hypertension and low adherence For these aims the study will be conducted as a phase II single-blind parallel-group randomized controlled trial with diverse adults with hypertension over 30 days Participants will answer surveys about their demographics knowledge about hypertension and their medication adherence They will then be randomized and either be given the standard of care or standard of care plus the intervention app-based reminders and feedback The intervention includes a brief training session on downloading and using the medication reminder app Across arms Participants will track their medication adherence for 30 days using the MEMS cap After the 30 days participants will take surveys about their adherence and knowledge about hypertension and have a brief exit interview with a member of the research team to talk about their experience and debrief them about the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None