Acute Myocardial Infarction (AMI)NCT01890018
Partners and Alerts: A Study of Social Forces in Medication Adherence
A study testing Electronic Pill Bottle tracking, Adherence Messaging and Social Influence in people with Acute Myocardial Infarction (AMI), run by University of Pennsylvania at 1 site in United States.
Trial summary
The overall objectives of this study are to improve medication adherence of patients and subsequent health outcomes. This study is designed to examine the existence of strong associations between social networks and health behavior. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI)
- What is being tested?
- Electronic Pill Bottle tracking, Adherence Messaging and Social Influence
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients must have
- experienced an AMI and have been placed on a once-a-day statin and have a medication adherence ratio (MPR) that is less than 80%.
- access to internet to create an account on Way to Heath.
Who cannot join
- There are no exclusion criterial for patients able to provide consent and who meet the eligibility criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The overall objectives of this study are to improve medication adherence of patients and subsequent health outcomes.
This study is designed to examine the existence of strong associations between social networks and health behavior. This study intends to demonstrate that social forces are particularly effective at building enduring habits for healthy behavior, specifically adherence to statin medication for this study. The investigators believe the improved medication adherence will result in fewer additional vascular events, following the most recent of these events, and will result in fewer patient hospitalizations. The investigators will leverage insights from the fields of social comparison (being provided with information about the actions of others prompts social comparison that can significantly influence behavior), social pressures (encouragement or discouragement from others is a powerful social force that can influence individual behavior), and social triggers (cues in the environment can motivate people to take certain actions and have powerful effects on purchasing behavior).
The results of this study and experience gained from the implementation of these interventions will be used to inform new versions of a larger trial intervention to be tested in new patient cohorts in a rapid cycle framework.
Read the detailed description
This study is a 4-arm pilot study involving 248 patients (62 per arm) who are on a once-a-day statin who have a medication adherence ratio (MPR) that is less than 80%. Patients in all arms would receive a GlowCap, manufactured by Vitality Inc., which records pill-bottle openings and be asked to use the GlowCap for that medication for the duration of the study.
The study arms leverage two strategies that the investigators think will be particularly effective at improving adherence and may be even more effective when used in tandem. Patients in some arms will be asked to select an adherence partner: another person who can help them adhere to their medication regimen. The investigators will contact this adherence partner and ask them to officially accept this role and provide guidance of their choosing as to how they can help the patient adhere. In addition, patients in some arms will receive an alert whenever two full days pass without their GlowCap being opened (i.e. 48 hours of non-adherence). This alert will encourage them to begin taking their medication again. The design allows for some patients to have both an adherence partner and to receive alerts after 48 hours of non-adherence. In these arms, the adherence partner would also receive the alert after 48 hours of non-adherence. This introduces a two-by-two design.
Subjects would spend 6 months in their randomly assigned treatment, and the investigators will compare adherence of subjects in each of the arms to one another.
The investigators plan to track daily adherence of patients to a prescribed chronic disease drug using a new technology that electronically monitors when a pill bottle has been opened. In our control condition, patients will be monitored but not be provided with any reminders, adherence information, or inclusion of friend of family member to help them adhere to their medication. Our four additional treatments will either: (1) email the patient after 48 hours of non-adherence; (2) allow the patient to select friend or family member to encourage medication adherence; (3) email the patient, as well as patient-selected friends or family members after 48 hours of non-adherence; or (4) provide the patient with a daily email, text message, or phone call reminder to take the pill.
- Conditions
- Acute Myocardial Infarction (AMI)
- Being tested
- Electronic Pill Bottle tracking, Adherence Messaging, Social Influence
- Keywords
- Acute Myocardial Infarction (AMI), taking a statin medication, also have a medication adherence ratio (MPR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Pill Bottle trackingBehavioural
All 4 groups will use the GlowCaps, a remote monitoring bottle, to take their statin medications
Adherence MessagingBehavioural
Some arms will receive adherence messages if they have not used the Glowcap bottles for 2 of the last 3 days.
Social InfluenceBehavioural
Some arms will select their own adherence feedback partner who will provide support in taking their medication as scheduled.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | This arm will use GlowCaps to have their adherence tracked with no additional modifications:
Arm 1. Control group no modifications
Electronic Pill Bottle tracking Receives: Behavioral: Electronic Pill Bottle tracking |
| Feedback group | Experimental | This arm will use GlowCaps to have their adherence tracked with the following modifications:
Arm 2. Feedback group participants will receive an adherence message after 48 hours of not using the GlowCaps
Electronic Pill Bottle tracking; Adherence Messaging Receives: Behavioral: Electronic Pill Bottle tracking; Behavioral: Adherence Messaging |
| Adherence partner group | Experimental | This arm will use GlowCaps to have their adherence tracked with the following modifications:
Arm 3. Adherence partner group participants will designate a family member or friend who will serve as an adherence partner, encouraging adherence of the patient
Electronic Pill Bottle tracking; Social Influence Receives: Behavioral: Electronic Pill Bottle tracking; Behavioral: Social Influence |
| Adherence partner along with feedback | Experimental | This arm will use GlowCaps to have their adherence tracked with the following modifications:
Arm 4. Adherence partner along with feedback group participants will designate a family member or friend who will serve as an adherence partner, encouraging adherence of the patient, both the patient and partner will receive a message after 48 hours of not using the GlowCaps
Electronic Pill Bottle tracking; Adherence Messaging; Social Influence Receives: Behavioral: Electronic Pill Bottle tracking; Behavioral: Adherence Messaging; Behavioral: Social Influence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glowcap bottle openings/Medication Adherence
Primary outcome will measure the the number of days the GlowCap pill bottle is opened at least 1 time over the 6 month enrollment period, to be measured at 6 months after enrollment for each participant. Medication adherence for this study is considered to be at least 1 registered GlowCap opening for each day enrolled on the study. (N days at least 1 opening/180 days = Medication Adherence %)
Measured: 6 months
Secondary outcomes (2)
Patient pharmacy benefits-this will be a composite outcome measure assessing MPR
Secondary outcomes will be gap ratios and medication possession ratios.
Measured: 18 months
Patient Claims records - this will be a composite outcome measure assessing frequency of hospitalization
Secondary outcomes will be the number of repeat vascular events, following a similar approach to MI-FREEE, hospitalization, repeat or new cardiovascular procedures, and cost.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judd B Kessler, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890018
- Sponsor's protocol ID
- 817167
- Other IDs
- 1C1CMS331009-01-00
- Status last verified
- Nov 2017
- First submitted
- 9 May 2013
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.
PubMed 33769555Kessler JB, Troxel AB, Asch DA, Mehta SJ, Marcus N, Lim R, Zhu J, Shrank W, Brennan T, Volpp KG. Partners and Alerts in Medication Adherence: A Randomized Clinical Trial. J Gen Intern Med. 2018 Sep;33(9):1536-1542. doi: 10.1007/s11606-018-4389-7. Epub 2018 Mar 15.
PubMed 29546659
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partners and Alerts: A Study of Social Forces in Medication Adherence
- ClinicalTrials.gov ID
- NCT01890018
- Acronym / sponsor ID
- 817167
- Conditions
- Acute Myocardial Infarction (AMI)
- Keywords
- Acute Myocardial Infarction (AMI), taking a statin medication, also have a medication adherence ratio (MPR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 1 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objectives of this study are to improve medication adherence of patients and subsequent health outcomes.
This study is designed to examine the existence of strong associations between social networks and health behavior. This study intends to demonstrate that social forces are particularly effective at building enduring habits for healthy behavior, specifically adherence to statin medication for this study. The investigators believe the improved medication adherence will result in fewer additional vascular events, following the most recent of these events, and will result in fewer patient hospitalizations. The investigators will leverage insights from the fields of social comparison (being provided with information about the actions of others prompts social comparison that can significantly influence behavior), social pressures (encouragement or discouragement from others is a powerful social force that can influence individual behavior), and social triggers (cues in the environment can motivate people to take certain actions and have powerful effects on purchasing behavior).
The results of this study and experience gained from the implementation of these interventions will be used to inform new versions of a larger trial intervention to be tested in new patient cohorts in a rapid cycle framework.
Detailed description
This study is a 4-arm pilot study involving 248 patients (62 per arm) who are on a once-a-day statin who have a medication adherence ratio (MPR) that is less than 80%. Patients in all arms would receive a GlowCap, manufactured by Vitality Inc., which records pill-bottle openings and be asked to use the GlowCap for that medication for the duration of the study.
The study arms leverage two strategies that the investigators think will be particularly effective at improving adherence and may be even more effective when used in tandem. Patients in some arms will be asked to select an adherence partner: another person who can help them adhere to their medication regimen. The investigators will contact this adherence partner and ask them to officially accept this role and provide guidance of their choosing as to how they can help the patient adhere. In addition, patients in some arms will receive an alert whenever two full days pass without their GlowCap being opened (i.e. 48 hours of non-adherence). This alert will encourage them to begin taking their medication again. The design allows for some patients to have both an adherence partner and to receive alerts after 48 hours of non-adherence. In these arms, the adherence partner would also receive the alert after 48 hours of non-adherence. This introduces a two-by-two design.
Subjects would spend 6 months in their randomly assigned treatment, and the investigators will compare adherence of subjects in each of the arms to one another.
The investigators plan to track daily adherence of patients to a prescribed chronic disease drug using a new technology that electronically monitors when a pill bottle has been opened. In our control condition, patients will be monitored but not be provided with any reminders, adherence information, or inclusion of friend of family member to help them adhere to their medication. Our four additional treatments will either: (1) email the patient after 48 hours of non-adherence; (2) allow the patient to select friend or family member to encourage medication adherence; (3) email the patient, as well as patient-selected friends or family members after 48 hours of non-adherence; or (4) provide the patient with a daily email, text message, or phone call reminder to take the pill.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Electronic Pill Bottle trackingThis arm will use GlowCaps to have their adherence tracked with no additional modifications: Arm 1. Control group no modifications Electronic Pill Bottle tracking |
| Feedback group | Experimental | Behavioral: Electronic Pill Bottle tracking, Behavioral: Adherence MessagingThis arm will use GlowCaps to have their adherence tracked with the following modifications: Arm 2. Feedback group participants will receive an adherence message after 48 hours of not using the GlowCaps Electronic Pill Bottle tracking; Adherence Messaging |
| Adherence partner group | Experimental | Behavioral: Electronic Pill Bottle tracking, Behavioral: Social InfluenceThis arm will use GlowCaps to have their adherence tracked with the following modifications: Arm 3. Adherence partner group participants will designate a family member or friend who will serve as an adherence partner, encouraging adherence of the patient Electronic Pill Bottle tracking; Social Influence |
| Adherence partner along with feedback | Experimental | Behavioral: Electronic Pill Bottle tracking, Behavioral: Adherence Messaging, Behavioral: Social InfluenceThis arm will use GlowCaps to have their adherence tracked with the following modifications: Arm 4. Adherence partner along with feedback group participants will designate a family member or friend who will serve as an adherence partner, encouraging adherence of the patient, both the patient and partner will receive a message after 48 hours of not using the GlowCaps Electronic Pill Bottle tracking; Adherence Messaging; Social Influence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have
- experienced an AMI and have been placed on a once-a-day statin and have a medication adherence ratio (MPR) that is less than 80%.
- access to internet to create an account on Way to Heath.
Key exclusion criteria (1 listed)
- There are no exclusion criterial for patients able to provide consent and who meet the eligibility criteria
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 |
|---|---|---|
| Electronic Pill Bottle trackingAll 4 groups will use the GlowCaps, a remote monitoring bottle, to take their statin medications | Behavioural | Adherence partner along with feedback, Adherence partner group, Control, Feedback group |
| Adherence MessagingSome arms will receive adherence messages if they have not used the Glowcap bottles for 2 of the last 3 days. | Behavioural | Adherence partner along with feedback, Feedback group |
| Social InfluenceSome arms will select their own adherence feedback partner who will provide support in taking their medication as scheduled. | Behavioural | Adherence partner along with feedback, Adherence partner group |
Primary outcome
Glowcap bottle openings/Medication Adherence
Time frame: 6 months
Primary outcome will measure the the number of days the GlowCap pill bottle is opened at least 1 time over the 6 month enrollment period, to be measured at 6 months after enrollment for each participant. Medication adherence for this study is considered to be at least 1 registered GlowCap opening for each day enrolled on the study. (N days at least 1 opening/180 days = Medication Adherence %)
2 secondary outcomes
Patient pharmacy benefits-this will be a composite outcome measure assessing MPR
Time frame: 18 months
Patient Claims records - this will be a composite outcome measure assessing frequency of hospitalization
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 33769555Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.
- Derived from this study: PubMed 29546659Kessler JB, Troxel AB, Asch DA, Mehta SJ, Marcus N, Lim R, Zhu J, Shrank W, Brennan T, Volpp KG. Partners and Alerts in Medication Adherence: A Randomized Clinical Trial. J Gen Intern Med. 2018 Sep;33(9):1536-1542. doi: 10.1007/s11606-018-4389-7. Epub 2018 Mar 15.
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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.
Judd B Kessler, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Pill Bottle tracking, Adherence Messaging and Social Influence in people with Acute Myocardial Infarction (AMI), run by University of Pennsylvania at 1 site 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 3 inclusion and 1 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Glowcap bottle openings/Medication Adherence (time frame: 6 months). 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 NCT01890018, 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 17 Nov 2017.