Medication AdherenceNCT03697083
Reminders Through Association & Prescription Adherence
A study testing Reminders Through Association in people with Medication Adherence, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to develop behavioral interventions that provide effective tools that policy makers can use to help individuals avoid forgetting to follow-through on important behaviors and for individuals to use to help themselves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Reminders Through Association
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 777 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2018to 21 Sep 2018
- 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
- Participants must be capable of sending and receiving text and picture messages on their phone.
Who cannot join
- Participants will only be excluded if they participated in the pilot study in which the investigators enrolled 150 participants. These participants will be excluded when they attempt to text the investigators to enroll.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to develop behavioral interventions that provide effective tools that policy makers can use to help individuals avoid forgetting to follow-through on important behaviors and for individuals to use to help themselves. In the investigators past research, they have shown that reminders through association work in the lab setting. The investigators seek to understand how this strategy can work in the field, especially when people are trying to fulfill a health outcome.
Read the detailed description
Participants enter an online survey where they are asked to confirm that they plan to pick up a prescription, state what day they plan to pick up their prescription, and indicate the type of location where the prescription will be picked up (e.g., pharmacy, hospital, doctors office, etc.). Participants are asked to participate in a prescription reminder program in which they will receive up to eight text messages from the researchers and send up to three text messages to the researchers. Participants are then quizzed about the reminder program to ensure they understand what they are signing up for. Participants are further told that if they follow the directions outlined in the program they will be compensated for participating in this survey via their phone number.
Participants who wish to enroll in the reminder program will initiate the text messaging by texting "STARTXXXX" to number provided. This validates that the participants received the message, have the capacity to text, and are willing to text. Participants are then randomly assigned to one of three conditions. In the treatment condition, participants will be prompted to think of a reminder cue that will help them remember to pick up the prescription. In the active control condition, participants will be asked to think about where they will store their prescription. Participants in the baseline control condition will simply be thanked for enrolling.
Participants in the treatment and active control conditions then receive a series of text messages prior to the scheduled pick up date reminding them to pick up their medication. In addition, the text message will prompt participants to text a picture of their prescription receipt to validate that they followed-through on their behavior. If participants text us a picture of their receipt that follows the guidelines outlined in the survey, participants are compensated.
- Conditions
- Medication Adherence
- Being tested
- Reminders Through Association, Active Control, Baseline Control
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reminders Through AssociationOther
Participants receive 8 text messages asking them to think of a reminder cue that will help them remember to pick up the prescription and use the cue.
Active ControlOther
Participants receive 8 text messages asking them to think of where they plan to store their medication once they pick it up and to think about that location on their intended date of pickup.
Baseline ControlOther
Participants receive 1 text message thanking participants for enrolling in the reminder program. Participants are not contacted further.
| Study group | Role | What they receive |
|---|---|---|
| Reminders Through Association Arm | Experimental | participants will be prompted to think of a reminder cue that will help them remember to pick up the prescription. Receives: Other: Reminders Through Association |
| Active Control Arm | Active comparator | Participants will be asked to think about where they will store their prescription. Receives: Other: Active Control |
| Baseline Control Arm | Active comparator | Participants are thanked for enrolling in the reminder program. Receives: Other: Baseline Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Picking up Prescription on Intended Date of Pickup
At the beginning of the study, participants indicate the date they plan to pick up their prescription. Participants are later asked to text a picture of their prescription receipt to the experimenter after they complete the prescription reminder program. The receipt must satisfy three criteria:
- The receipt must show that a prescription was purchased.
- The receipt must show the date of purchase. This date of purchase must match the participant's intended pick up date.
- The participant must write the word "End" on their receipt. Upon receiving the picture text, one research assistant will verify that the image of the receipt satisfies all three criteria. the investigators' primary dependent variable is binary taking the value one if the participant sends a picture of their receipt to the investigators that satisfies all criteria stated above and taking the value zero if otherwise.
Measured: The time frame can range from less than 1 day to a maximum of 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start14 Jun 2018
- Primary completion21 Sep 2018
- Study completion21 Sep 2018
Why it stopped: The primary hypotheses were unsupported with half of the data collected.
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.
- Other trials for Medication AdherenceStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 777 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Milkman, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697083
- Sponsor's protocol ID
- 825556
- Status last verified
- Jun 2019
- First submitted
- 28 Aug 2018
- Last updated
- 6 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reminders Through Association & Prescription Adherence
- ClinicalTrials.gov ID
- NCT03697083
- Acronym / sponsor ID
- 825556
- Conditions
- Medication Adherence
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The primary hypotheses were unsupported with half of the data collected.
- Enrolment
- 777 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 21 Sep 2018 (actual)
- Study completion
- 21 Sep 2018 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Posted 6 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop behavioral interventions that provide effective tools that policy makers can use to help individuals avoid forgetting to follow-through on important behaviors and for individuals to use to help themselves. In the investigators past research, they have shown that reminders through association work in the lab setting. The investigators seek to understand how this strategy can work in the field, especially when people are trying to fulfill a health outcome.
Detailed description
Participants enter an online survey where they are asked to confirm that they plan to pick up a prescription, state what day they plan to pick up their prescription, and indicate the type of location where the prescription will be picked up (e.g., pharmacy, hospital, doctors office, etc.). Participants are asked to participate in a prescription reminder program in which they will receive up to eight text messages from the researchers and send up to three text messages to the researchers. Participants are then quizzed about the reminder program to ensure they understand what they are signing up for. Participants are further told that if they follow the directions outlined in the program they will be compensated for participating in this survey via their phone number.
Participants who wish to enroll in the reminder program will initiate the text messaging by texting "STARTXXXX" to number provided. This validates that the participants received the message, have the capacity to text, and are willing to text. Participants are then randomly assigned to one of three conditions. In the treatment condition, participants will be prompted to think of a reminder cue that will help them remember to pick up the prescription. In the active control condition, participants will be asked to think about where they will store their prescription. Participants in the baseline control condition will simply be thanked for enrolling.
Participants in the treatment and active control conditions then receive a series of text messages prior to the scheduled pick up date reminding them to pick up their medication. In addition, the text message will prompt participants to text a picture of their prescription receipt to validate that they followed-through on their behavior. If participants text us a picture of their receipt that follows the guidelines outlined in the survey, participants are compensated.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reminders Through Association Arm | Experimental | Other: Reminders Through Associationparticipants will be prompted to think of a reminder cue that will help them remember to pick up the prescription. |
| Active Control Arm | Active comparator | Other: Active ControlParticipants will be asked to think about where they will store their prescription. |
| Baseline Control Arm | Active comparator | Other: Baseline ControlParticipants are thanked for enrolling in the reminder program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must be capable of sending and receiving text and picture messages on their phone.
Key exclusion criteria (1 listed)
- Participants will only be excluded if they participated in the pilot study in which the investigators enrolled 150 participants. These participants will be excluded when they attempt to text the investigators to enroll.
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 |
|---|---|---|
| Reminders Through AssociationParticipants receive 8 text messages asking them to think of a reminder cue that will help them remember to pick up the prescription and use the cue. | Other | Reminders Through Association Arm |
| Active ControlParticipants receive 8 text messages asking them to think of where they plan to store their medication once they pick it up and to think about that location on their intended date of pickup. | Other | Active Control Arm |
| Baseline ControlParticipants receive 1 text message thanking participants for enrolling in the reminder program. Participants are not contacted further. | Other | Baseline Control Arm |
Primary outcome
Picking up Prescription on Intended Date of Pickup
Time frame: The time frame can range from less than 1 day to a maximum of 7 days.
At the beginning of the study, participants indicate the date they plan to pick up their prescription. Participants are later asked to text a picture of their prescription receipt to the experimenter after they complete the prescription reminder program. The receipt must satisfy three criteria: 1. The receipt must show that a prescription was purchased. 2. The receipt must show the date of purchase. This date of purchase must match the participant's intended pick up date. 3. The participant must write the word "End" on their receipt. Upon receiving the picture text, one research assistant will verify that the image of the receipt satisfies all three criteria. the investigators' primary dependent variable is binary taking the value one if the participant sends a picture of their receipt to the investigators that satisfies all criteria stated above and taking the value zero if otherwise.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Katherine Milkman, 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 Reminders Through Association in people with Medication Adherence, 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 1 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: stopped early, as of the sponsor's last update on 6 Aug 2019. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2019). 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?
Picking up Prescription on Intended Date of Pickup (time frame: The time frame can range from less than 1 day to a maximum of 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2019.