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Medication adherence is a critical aspect of achieving optimal health outcomes. Thirty to 50% of patients adhere to long-term medication treatment of chronic diseases. Non adherence has been shown to result in worsening disease, increased healthcare expenditures, complications and even death. Medically underserved communities have higher rates of medication nonadherence and a higher prevalence of chronic conditions and often receive care at Federally Qualified Health Centers (FQHCs) which are reporting caring for increasingly complex chronic conditions. Smartphone mobile phone ownership has increased to 76% in low income Americans, but this population has been underrepresented in mobile health intervention studies. This two-group, cluster randomized by site, randomized controlled trial will investigate the effect of a medication adherence smartphone mobile application (app) which provides reminders on patient medication adherence, on medication self-efficacy, medication knowledge and medication social support. Independently, each of these concepts have been shown to support medication adherence. However in the context of delivery by a medication adherence app in a variety of chronic illnesses in a medically underserved population, little is known. It will also explore if those who accessed educational materials within the app report greater medication knowledge than those who do not and if participants who choose to use the additional Medfriend feature report greater medication social support than those who do not. The study will also explore patients' perceptions on the usefulness and satisfaction with the app features.
Medication adherence is a critical aspect of achieving optimal health outcomes. Thirty to 50% of patients adhere to long-term medication treatment of chronic diseases. Non adherence has been shown to result in worsening disease, increased healthcare expenditures, complications and even death. Medically underserved communities have higher rates of medication nonadherence and a higher prevalence of chronic conditions and often receive care at Federally Qualified Health Centers (FQHCs) which are reporting caring for increasingly complex chronic conditions. Smartphone mobile phone ownership has increased to 76% in low income Americans, but this population has been underrepresented in mobile health intervention studies. This two-group, cluster randomized by site, randomized controlled trial will investigate the effect of a medication adherence smartphone mobile application (app) which provides reminders on patient medication adherence, on medication self-efficacy, medication knowledge and medication social support. Independently, each of these concepts have been shown to support medication adherence. However in the context of delivery by a medication adherence app in a variety of chronic illnesses in a medically underserved population, little is known. It will also explore if those who accessed educational materials within the app report greater medication knowledge than those who do not and if participants who choose to use the additional Medfriend feature report greater medication social support than those who do not. The study will also explore patients' perceptions on the usefulness and satisfaction with the app features.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants using the medication adherence mobile application. | Experimental | Participants in this arm will use the Medisafe app to receive medication reminders for thirty days. |
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| Participants using a printed copy of their medication list. | Active Comparator | Participants in this arm will use a printed out copy of their medication list for thirty days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medisafe smartphone mobile application | Behavioral | The medication adherence smartphone mobile application (app) will provide reminders to take individual patient medications and offers medication information and a social support feature. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Medication Adherence as Measured by the Adherence to Refills and Medications Scale (ARMS) | The ARMS is a global (continuous) 12-item scale, responses range from 1 (none) to 4 (all of the time) with a possible score of 12-48, patients with low ARMS scores indicate better adherence, it is valid and reliable in a low-literacy chronic disease population. | Baseline to 30 days. |
| Change in Medication Self-efficacy as Measured by the Self-efficacy for Appropriate Medication Use Scale (SEAMS) | The SEAMS is a global (continuous) 13-item scale, responses range from 1 (not confident) to 3 (very confident), with a possible score of 13-39. Patients with higher scores indicate higher levels of self-efficacy for medication adherence. It is valid and reliable in low-literacy chronic disease populations. Patients are asked their level of confidence about taking medications correctly. | Baseline to 30 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deonni P Stolldorf, PhD, RN | Vanderbilt University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCHC's Smilow Life Center | Norwalk | Connecticut | 06854 | United States | ||
| Norwalk Community Health Center, Inc. (NCHC) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39773694 | Derived | Hartch C, Dietrich MS, Lancaster BJ, Mulvaney SA, Stolldorf DP. Satisfaction and Usability of a Commercially Available Medication Adherence App (Medisafe) Among Medically Underserved Patients With Chronic Illnesses: Survey Study. JMIR Hum Factors. 2025 Jan 7;12:e63653. doi: 10.2196/63653. | |
| 38127174 | Derived |
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Participants were recruited from a healthcare center, as noted in the protocol section.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Using the Medication Adherence Mobile Application. | Participants in this arm will use the Medisafe app to receive medication reminders for thirty days. Medisafe smartphone mobile application: The medication adherence smartphone mobile application (app) will provide reminders to take individual patient medications and offers medication information and a social support feature. |
| FG001 | Participants Using a Printed Copy of Their Medication List. | Participants in this arm will use a printed out copy of their medication list for thirty days. Printed medication list: Patients will receive a printed out medication list from their electronic medical record. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Using the Medication Adherence Mobile Application. | Participants in this arm will use the Medisafe app to receive medication reminders for thirty days. Medisafe smartphone mobile application: The medication adherence smartphone mobile application (app) will provide reminders to take individual patient medications and offers medication information and a social support feature. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Medication Adherence as Measured by the Adherence to Refills and Medications Scale (ARMS) | The ARMS is a global (continuous) 12-item scale, responses range from 1 (none) to 4 (all of the time) with a possible score of 12-48, patients with low ARMS scores indicate better adherence, it is valid and reliable in a low-literacy chronic disease population. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline to 30 days. |
|
Adverse events were collected through enrollment to study completion, an average of 30 days for each participant.
There were no adverse events reported through study completion, an average of 30 days for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants Using the Medication Adherence Mobile Application. | Participants in this arm will use the Medisafe app to receive medication reminders for thirty days. Medisafe smartphone mobile application: The medication adherence smartphone mobile application (app) will provide reminders to take individual patient medications and offers medication information and a social support feature. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christa Hartch, PI | Vanderbilt University | 203-979-2044 | christahartch@me.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2021 | Mar 25, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 3, 2021 | Mar 25, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| Printed medication list | Behavioral | Patients will receive a printed out medication list from their electronic medical record. |
|
| Norwalk |
| Connecticut |
| 06854 |
| United States |
| Hartch CE, Dietrich MS, Lancaster BJ, Stolldorf DP, Mulvaney SA. Effects of a medication adherence app among medically underserved adults with chronic illness: a randomized controlled trial. J Behav Med. 2024 Jun;47(3):389-404. doi: 10.1007/s10865-023-00446-2. Epub 2023 Dec 21. |
| BG001 | Participants Using a Printed Copy of Their Medication List. | Participants in this arm will use a printed out copy of their medication list for thirty days. Printed medication list: Patients will receive a printed out medication list from their electronic medical record. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ARMS | Median | Inter-Quartile Range | units on a scale |
|
| SEAMS | Median | Inter-Quartile Range | units on a scale |
|
| Participants Using a Printed Copy of Their Medication List. |
Participants in this arm will use a printed out copy of their medication list for thirty days. Printed medication list: Patients will receive a printed out medication list from their electronic medical record. |
|
|
| Primary | Change in Medication Self-efficacy as Measured by the Self-efficacy for Appropriate Medication Use Scale (SEAMS) | The SEAMS is a global (continuous) 13-item scale, responses range from 1 (not confident) to 3 (very confident), with a possible score of 13-39. Patients with higher scores indicate higher levels of self-efficacy for medication adherence. It is valid and reliable in low-literacy chronic disease populations. Patients are asked their level of confidence about taking medications correctly. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline to 30 days. |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Participants Using a Printed Copy of Their Medication List. | Participants in this arm will use a printed out copy of their medication list for thirty days. Printed medication list: Patients will receive a printed out medication list from their electronic medical record. | 0 | 31 | 0 | 31 | 0 | 31 |
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| D001519 | Behavior |