Clinical trial NCT06034301: Pill Bottle vs Reminder App
Official title: Feasibility of Interventions Impacting Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Medication Adherence
Keywords: Occupational Therapy
Medication Management
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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 (i.e. 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.

Eligibility criteria: Inclusion Criteria:

* currently be prescribed an antihypertensive medication by their doctor
* have taken antihypertensive medication for the last year
* be willing to download and use a new app on their phone for the study
* score a 34 or lower on the Hill Bone compliance scale

Exclusion Criteria:

* need assistance taking their medications
* have a severe cognitive impairment
* have a severe visual impairment that prevents them from reading notifications on their phone
* use a pillbox to take their medications
* do not use a smart phone or their smart phone does not meet the requirements for the app to be downloaded

Primary outcomes:
measure: Medication Event Monitoring System (MEMS) Cap
timeFrame: 30 days
measure: Exit interview
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jaclyn Schwartz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahmed I, Ahmad NS, Ali S, Ali S, George A, Saleem Danish H, Uppal E, Soo J, Mobasheri MH, King D, Cox B, Darzi A. Medication Adherence Apps: Review and Content Analysis. JMIR Mhealth Uhealth. 2018 Mar 16;6(3):e62. doi: 10.2196/mhealth.6432.
citation: Aldeer M., Javanmard M., & Martin R. P. (2018). A review of medication adherence monitoring technologies. Applied System Innovation, 1(2), 2. https://doi: 10.3390/asi1020014.
citation: Morrissey EC, Casey M, Glynn LG, Walsh JC, Molloy GJ. Smartphone apps for improving medication adherence in hypertension: patients' perspectives. Patient Prefer Adherence. 2018 May 14;12:813-822. doi: 10.2147/PPA.S145647. eCollection 2018.
citation: Santo K, Chow CK, Thiagalingam A, Rogers K, Chalmers J, Redfern J. MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol. BMJ Open. 2017 Oct 8;7(10):e017540. doi: 10.1136/bmjopen-2017-017540.
citation: Santo K, Singleton A, Chow CK, Redfern J. Evaluating Reach, Acceptability, Utility, and Engagement with An App-Based Intervention to Improve Medication Adherence in Patients with Coronary Heart Disease in the MedApp-CHD Study: A Mixed-Methods Evaluation. Med Sci (Basel). 2019 Jun 4;7(6):68. doi: 10.3390/medsci7060068.
citation: Santo K, Singleton A, Rogers K, Thiagalingam A, Chalmers J, Chow CK, Redfern J. Medication reminder applications to improve adherence in coronary heart disease: a randomised clinical trial. Heart. 2019 Feb;105(4):323-329. doi: 10.1136/heartjnl-2018-313479. Epub 2018 Aug 27.