Medication Adherence, Self Efficacy
Conditions
Keywords
Medication Knowledge, Medication Social Support, Medication Self Efficacy, Mobile Phone Applications, Medically Underserved Populations
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMedisafe 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.
BEHAVIORALPrinted medication list
Patients will receive a printed out medication list from their electronic medical record.
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults aged 18 years and older * speak and understand English * personally own and use an Android or Apple smartphone and * take at least 1 medication for a chronic illness based on their computerized medical record at the health center.
Exclusion criteria
* already using a medication reminder app or other electronic reminder system such as phone alarms * own smartphones that are not capable of downloading the app * patients with severe dementia or serious mental illness, and * inability to use a mobile phone or the medication reminder software either physically or cognitively.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Medication Adherence as Measured by the Adherence to Refills and Medications Scale (ARMS) | Baseline to 30 days. | 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. |
| Change in Medication Self-efficacy as Measured by the Self-efficacy for Appropriate Medication Use Scale (SEAMS) | Baseline to 30 days. | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from a healthcare center, as noted in the protocol section.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 31 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | One participant had no data because they were unable to download the app despite multiple attempts | 1 | 0 |
Baseline characteristics
| Characteristic | Participants Using the Medication Adherence Mobile Application. | Participants Using a Printed Copy of Their Medication List. | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 6 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants | 25 Participants | 52 Participants |
| Age, Continuous | 53.50 years | 51 years | 53 years |
| ARMS | 18.5 units on a scale | 17.0 units on a scale | 18.0 units on a scale |
| Race/Ethnicity, Customized Asian | 5 participants | 2 participants | 7 participants |
| Race/Ethnicity, Customized Black or African American | 10 participants | 13 participants | 23 participants |
| Race/Ethnicity, Customized Chose not to respond | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 4 participants | 10 participants | 14 participants |
| Race/Ethnicity, Customized Native American or Alaska Native | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Other | 3 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized White | 6 participants | 3 participants | 9 participants |
| Region of Enrollment United States | 30 Participants | 31 Participants | 61 Participants |
| SEAMS | 29.0 units on a scale | 31.0 units on a scale | 29.0 units on a scale |
| Sex: Female, Male Female | 17 Participants | 12 Participants | 29 Participants |
| Sex: Female, Male Male | 13 Participants | 19 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 31 |
| other Total, other adverse events | 0 / 30 | 0 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 31 |
Outcome results
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.
Time frame: Baseline to 30 days.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants Using the Medication Adherence Mobile Application. | Change in Medication Adherence as Measured by the Adherence to Refills and Medications Scale (ARMS) | -4.0 score on a scale |
| Participants Using a Printed Copy of Their Medication List. | Change in Medication Adherence as Measured by the Adherence to Refills and Medications Scale (ARMS) | -1.0 score on a scale |
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.
Time frame: Baseline to 30 days.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Participants Using the Medication Adherence Mobile Application. | Change in Medication Self-efficacy as Measured by the Self-efficacy for Appropriate Medication Use Scale (SEAMS) | 3.5 score on a scale |
| Participants Using a Printed Copy of Their Medication List. | Change in Medication Self-efficacy as Measured by the Self-efficacy for Appropriate Medication Use Scale (SEAMS) | 0.0 score on a scale |