Medication AdherenceNCT05098743
The Influence of a Medication Adherence Smartphone Application on Medication Adherence in Chronic Illness
A study testing Medisafe smartphone mobile application and Printed medication list in people with Medication Adherence and Self Efficacy, run by Vanderbilt University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Self Efficacy
- What is being tested?
- Medisafe smartphone mobile application and Printed medication list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Nov 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NCHC's Smilow Life Center
Norwalk, Connecticut, 06854
Norwalk Community Health Center, Inc. (NCHC)
Norwalk, Connecticut, 06854
About this study
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.
Read the 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.
- Conditions
- Medication Adherence, Self Efficacy
- Being tested
- Medisafe smartphone mobile application, Printed medication list
- Keywords
- Medication Knowledge, Medication Social Support, Medication Self Efficacy, Mobile Phone Applications, Medically Underserved Populations
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medisafe smartphone mobile applicationBehavioural
The medication adherence smartphone mobile application (app) will provide reminders to take individual patient medications and offers medication information and a social support feature.
Printed medication listBehavioural
Patients will receive a printed out medication list from their electronic medical record.
| Study group | Role | What they receive |
|---|---|---|
| Participants using the medication adherence mobile application. | Experimental | Participants in this arm will use the Medisafe app to receive medication reminders for thirty days. Receives: Behavioral: Medisafe smartphone mobile application |
| 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. Receives: Behavioral: Printed medication list |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start19 Nov 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christa Hartch, Vanderbilt University
- Investigators
- Deonni P Stolldorf, PhD, RN, Study chair, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098743
- Sponsor's protocol ID
- 211409
- Status last verified
- Mar 2024
- First submitted
- 15 Oct 2021
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39773694Hartch 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.
PubMed 38127174
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of a Medication Adherence Smartphone Application on Medication Adherence in Chronic Illness
- ClinicalTrials.gov ID
- NCT05098743
- Acronym / sponsor ID
- 211409
- Conditions
- Medication Adherence, Self Efficacy
- Keywords
- Medication Knowledge, Medication Social Support, Medication Self Efficacy, Mobile Phone Applications, Medically Underserved Populations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Posted 19 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants using the medication adherence mobile application. | Experimental | Behavioral: Medisafe smartphone mobile applicationParticipants in this arm will use the Medisafe app to receive medication reminders for thirty days. |
| Participants using a printed copy of their medication list. | Active comparator | Behavioral: Printed medication listParticipants in this arm will use a printed out copy of their medication list for thirty days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medisafe smartphone mobile applicationThe medication adherence smartphone mobile application (app) will provide reminders to take individual patient medications and offers medication information and a social support feature. | Behavioural | Participants using the medication adherence mobile application. |
| Printed medication listPatients will receive a printed out medication list from their electronic medical record. | Behavioural | Participants using a printed copy of their medication list. |
Primary outcome
Change in Medication Adherence as Measured by the Adherence to Refills and Medications Scale (ARMS)
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39773694Hartch 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.
- Derived from this study: PubMed 38127174Hartch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deonni P Stolldorf, PhD, RN study chair
Vanderbilt University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medisafe smartphone mobile application and Printed medication list in people with Medication Adherence and Self Efficacy, run by Vanderbilt University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Medication Adherence as Measured by the Adherence to Refills and Medications Scale (ARMS) (time frame: Baseline to 30 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05098743, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.