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Reminders Through Association & Prescription Adherence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03697083
Recruitment Status : Terminated (The primary hypotheses were unsupported with half of the data collected.)
First Posted : October 5, 2018
Results First Posted : August 6, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE August 28, 2018
First Posted Date  ICMJE October 5, 2018
Results First Submitted Date  ICMJE February 25, 2019
Results First Posted Date  ICMJE August 6, 2019
Last Update Posted Date August 6, 2019
Actual Study Start Date  ICMJE June 14, 2018
Actual Primary Completion Date September 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03697083 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reminders Through Association & Prescription Adherence
Official Title  ICMJE Reminders Through Association & Prescription Adherence
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Medication Adherence
Intervention  ICMJE
  • Other: Reminders Through Association
    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.
  • Other: Active Control
    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.
  • Other: Baseline Control
    Participants receive 1 text message thanking participants for enrolling in the reminder program. Participants are not contacted further.
Study Arms  ICMJE
  • Experimental: Reminders Through Association Arm
    participants will be prompted to think of a reminder cue that will help them remember to pick up the prescription.
    Intervention: Other: Reminders Through Association
  • Active Comparator: Active Control Arm
    Participants will be asked to think about where they will store their prescription.
    Intervention: Other: Active Control
  • Active Comparator: Baseline Control Arm
    Participants are thanked for enrolling in the reminder program.
    Intervention: Other: Baseline Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 19, 2019)
777
Original Estimated Enrollment  ICMJE
 (submitted: October 3, 2018)
1200
Actual Study Completion Date  ICMJE September 21, 2018
Actual Primary Completion Date September 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must be capable of sending and receiving text and picture messages on their phone.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03697083
Other Study ID Numbers  ICMJE 825556
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Katherine Milkman, PhD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP